High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury
Phase: NA
Conditions: Mild Traumatic Brain Injury
Sponsor: University of New Mexico

PROTOCOL TITLE:  High-Definition Transcranial Direct Current Stimulation for 
Sensory Deficits in Complex TBI
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PROTOCOL TITLE:
High-Definition Transcranial Direct Current Stimulation for Sensory Deficits in 
Complex TBI
PRINCIPAL INVESTIGATOR:
Davin Quinn, MD
Department of Psychiatry
VERSION NUMBER:
#16
DATE:
 November 30, 2020
REGULATORY FRAMEWORK:
Please indicate all that apply:
x
DOD (Department of Defense)
DOE (Department of Energy)
DOJ (Department of Justice)
ED (Department of Education)
EPA (Environmental Protection Agency)
FDA (Food and Drug Administration)
HHS (Department of Health and Human Services)
VA
Other:      
Is this a clinical trial under ICH-GCP E6?   x Yes   
 No
If yes, please confirm that the research team is familiar with and agrees to 
comply with the investigator requirements cited in ICH-GCP E6.  x Yes   
 No 
ICH-GCP E6 can be accessed by copying and pasting this URL into your 
browser: 
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf

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Table of Contents
1.
Objectives.....................................................................................................................3
2.
Background ..................................................................................................................3
3.
Study Design ................................................................................................................4
4.
Inclusion and Exclusion Criteria ..................................................................................6
5.
Number of Subjects......................................................................................................7
6.
Study Timelines............................................................................................................7
7.
Study Endpoints ...........................................................................................................7
8.
Research Setting...........................................................................................................7
9.
Resources Available.....................................................................................................7
10.
Prior Approvals.......................................................................................................10
11.
Multi-Site Research ................................................................................................10
12.
Study Procedures ....................................................................................................11
13.
Data Analysis..........................................................................................................13
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects...........................13
15.
Withdrawal of Subjects...........................................................................................14
16.
Data Management/Confidentiality..........................................................................14
17.
Data and Specimen Banking...................................................................................16
18.
Risks to Subjects.....................................................................................................16
19.
Potential Benefits to Subjects .................................................................................17
20.
Recruitment Methods..............................................................................................17
21.
Provisions to Protect the Privacy Interests of Subjects ..........................................17
22.
Economic Burden to Subjects.................................................................................18
23.
Compensation .........................................................................................................19
24.
Compensation for Research-Related Injury............................................................19
25.
Consent Process......................................................................................................19
26.
Documentation of Consent (see attached forms)....................................................20
27.
Study Test Results/Incidental Findings (see next section) .....................................20
28.
Sharing Study Progress or Results with Subjects...................................................20
29.
Inclusion of Vulnerable Populations ......................................................................20
30.
Community-Based Participatory Research N/A.....................................................21
31.
Research Involving American Indian/Native Populations N/A..............................21
32.
Transnational Research N/A...................................................................................21
33.
Drugs or Devices ....................................................................................................21
34.
Checklist Section ....................................................................................................22
Appendix A........................................................................................................................35

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1. Objectives
Aim 1: To use magnetoencephalography (MEG) and structural magnetic resonance imaging (MRI) in 
Veterans and Active Duty Service members, and civilians with mTBI and sensory postconcussive 
symptoms to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as 
shown by reliable changes in the functional connectivity between the cognitive control network (CCN) 
and sensory system network (SSN) following stimulation; 
Aim 2: this intervention will result in long-term improvements in measures of executive function, 
depression/anxiety, and quality of life. 
These objectives were formulated based on a) our extensive clinical experience treating patients with 
TBI and postconcussive symptoms (PCS); b) our previous studies of network dysfunction in TBI and 
other disorders using functional MRI and MEG; and c) our pilot data showing improvements in 
executive function and PCS in TBI patients following tDCS and training.
2. Background
Arguably the most common and disabling postconcussive symptoms (PCS) after a traumatic brain 
injury (TBI) occur in the sensory systems, and include vestibular (dizziness, nausea), visual (difficulty 
reading, blurry vision), and auditory (tinnitus, effortful comprehension) disturbances.1,2 Subject who 
sustain a mild TBI (mTBI) frequently report symptoms in multiple sensory domains, despite a 
significant percentage having normal visual and auditory acuity.3,4 These findings suggest that sensory 
symptoms arise not from a problem with sensory cortex itself but from a problem with “top-down” 
processing of sensory information. This processing may be conceptualized as the communication 
between two distinct brain networks: a unimodal sensory system network (SSN) that receives and 
refines sensory inputs (i.e. visual or auditory cortices) and a cognitive control network (CCN) of 
prefrontal and temporo-parietal association areas that integrates, interprets, and prioritizes 
multisensory data.5,6 Cognitive control deficits are commonly found in mTBI;5,9 utilizing functional 
magnetic resonance imaging (fMRI) and magnetoencephalography (MEG), we have documented 
abnormalities in CCN activation during visual and auditory attention tasks, as well as top-down 
attention-related modulations (ARMs) of SSNs by the CCN in mTBI patients.6,8 Eye movement 
abnormalities are also prevalent after TBI,2,9 and our group has used eye-tracking technology with both 
fMRI and MEG to identify nodes in the visuomotor control network that overlap with auditory and 
visual SSNs.10,11 Our recent findings confirm earlier work suggesting the combination of MRI with MEG 
(termed magnetic source imaging or MSI) is significantly more sensitive than other modalities such as 
electroencephalography (EEG) for detecting subtle sensory dysfunction after mTBI.9,12 This sensitivity 
is due to the high spatial resolution (~3 millimeter) of MRI, when combined with the high temporal 
resolution (< 1 millisecond) of MEG, that allows precise measurement of the brain’s magnetic fields. 
Despite our ability to identify top-down processing deficits underlying sensory PCS, proven treatments 
that specifically address these deficits are few. N-acetylcysteine and vestibular training are 
recommended for acute and subacute concussions, but are understudied in intractable cases, and may 
require frequent office visits over prolonged periods to ensure efficacy.13 New tools are needed that 
can “normalize” aberrant CCN activity to rapidly reduce symptom burden (which goes above and 
beyond the sensory domain?) and improve quality of life. One intervention that holds significant 
promise is high-definition transcranial direct current stimulation (HD-tDCS). HD-tDCS is a well-
tolerated, non-invasive, Non-Significant Risk technique that utilizes focused electrical fields applied 
through the scalp to modulate neuronal excitability. To date, HD-tDCS has never been studied for sensory 
dysfunction after TBI. Unlike transcranial magnetic stimulation, HD-tDCS has negligible seizure risk 
and can easily be paired with simultaneous rehabilitation. Over the last four years our group has 
conducted numerous successful investigations into the mechanisms of tDCS cognition-enhancing 
effects in both healthy and neurologically impaired populations.14–16 We are currently running a NIH-
funded study of tDCS for chronic PCS after mild-moderate TBI, and initial pilot data from this trial 
indicate significant reduction in PCS and improvements in executive function with stimulation paired 
with cognitive training. We have also developed highly detailed, computational finite element models 

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demonstrating that HD-tDCS can more precisely steer current to specific neural networks by using a 
greater number of electrodes than traditional sponge-based tDCS.16,17 Thus we are well-prepared to 
explore HD-tDCS as an intervention to target aberrant CCN activity identified with MSI.
3. Study Design
We will recruit 120 participants ages 18-69 for the study:  80 participants with mTBI (“intervention 
participants”), and 40 non-TBI healthy subjects (“healthy controls”).  Military TBI population 
participants will participate in two components to the study—one component at the NMVAHCS, and 
one component at the UNM Center for Brain Recovery and Repair (UNM CBRR)—each with its own 
consent and protocol, and governed by its respective Institutional Review Board.  Military population 
healthy controls will only participate at the UNM CBRR.  Civilian TBI and healthy control populations 
will only participate at the UNM CBRR. All study activities occurring at UNM CBRR will be supervised 
by the UNM HSC IRB.
For the purposes of UNM IRB review, this document will discuss in detail only the aspects of the 
protocol which take place at UNM/MRN.  
Aspects of the protocol which take place at the NMVAHCS (i.e., Some long-term follow-up visits with 
Veterans may take place at the NMVAHCS if they prefer to complete these visits in-person and some 
recruitment activities)will be reviewed by the NMVAHCS IRB Committee.  Finally, the USAMRMC IRB 
will review both protocols to ensure compliance with Department of Defense Human Research 
Protections regulations. 
There are a total of 17 visits for this study:  

2 visits to complete Baseline assessments

10 visits to complete Stimulation

2 visits to complete Post-Stimulation assessments3 Long-term follow-up visits (either by 
phone or in-person)

Recruitment populations will include the following:
Military TBI and military healthy control populations:  Patients from the NMVAHCS Polytrauma Clinic, 
the Kirtland Air Base 377th Medical Group Clinic, and community dwelling Veterans and Active Duty 
Service Members.
Civilian TBI and civilian healthy control populations:  civilians in the community or referred by 
clinicians.
Qualifying TBI intervention (both military and civilian) participants will have a mild TBI with chronic 
sensory PCS (auditory, visual, and/or vestibular) reported on the Neurobehavioral Symptom 
Inventory (NSI) and normal hearing and visual acuity. 
After screening and consent, all participants (military and civilian; TBI and healthy controls) will 
undergo demographic survey and neuropsychological assessment at the UNM CBRR Clinical Core. 
Common Data Elements (CDE) instruments, of depression, post-traumatic stress disorder (PTSD), and 
the quality of life questionnaire will be collected. Participants will then undergo structural MRI 
scanning and MEG scanning at the Mind Research Network (MRN) at UNM, adjacent to the CBRR. 
During the 60-minute MEG session, participants will perform tests of auditory orienting, visual 
attention, and pro/anti-saccades using eye-tracking, while event-related changes in brain activity are 
recorded. All data will be entered and stored securely in the MRN Collaborative Informatics and 
Neuroimaging Suite (COINS). 
All TBI participants (military and civilian) will receive either active or sham anodal HD-tDCS to the left 
DLPFC for a total of 30 minutes each day for ten consecutive weekdays at the University of New Mexico 
Center for Brain Recovery and Repair.  After the intervention, TBI participants will then repeat all 

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demographic, cognitive, and imaging assessments. MEG sources will be reconstructed within 
individual MRIs to create pre- and post-treatment MSI current distribution models for each task. (Aim 
1.) 
Followup Visits: 
Military TBI participants:  At 1, 3, and 6-months post-stimulation, intervention participants will be 
surveyed regarding symptom burden and quality of life using the NSI, PGIC, and Promis-29. (Aim 2.) 
These assessments will be overseen by the NMVAHCS IRB.
Civilian TBI participants.  At 1, 3, and 6-months post-stimulation, intervention participants will be 
surveyed regarding symptom burden and quality of life using the NSI, PGIC, and Promis-29.  These 
assessments will be overseen by the UNM IRB.
The main behavioral outcome variable is degree of improvement in sensory processing tests and 
symptom severity. MSI outcome variables are the changes in event related field source strength and 
latency during auditory, visual, and saccades tasks. Secondary outcome variables include changes in 
accuracy on cognitive control tasks PTSD and depression symptoms, and quality of life ratings.

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4. Inclusion and Exclusion Criteria
Inclusion Criteria
Out of the total 120 subjects to be recruited, 80 TBI subjects (Veterans, Active Duty, and civilians) will 

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be recruited to undergo the full protocol, while an imaging-only control group of 40 non-TBI subjects 
(Veterans, Active Duty Service Members, and civilians)  will be recruited to undergo only the initial 
baseline assessments. This imaging-only group will have the same inclusion and exclusion criteria 
except they will not have had a head injury. Subjects will be enrolled in this study if they 1) are aged 
18-69, 2) have suffered a mild TBI (alteration in neurological functioning < 24 hours, loss of 
consciousness (LOC) less than 30 minutes, Glasgow coma scale (GCS) score (if available) of between 
13 and 15 acutely, and less than 24 hours of post-traumatic amnesia (PTA); 2) were injured between 
3 months and 20 years ago; 3) have post-traumatic sensory symptoms as evidenced by endorsing at 
least 2 out of 12 sensory symptoms on the Neurobehavioral Symptom Inventory (NSI), a measure of 
post-traumatic symptoms from the NIH Common Data Elements (CDE) to a severity of “3” or higher, 
4) are fluent in English, 5) have been on stable doses of any psychotropic medications for the past 2 
months. The imaging-only group will have the same inclusion and exclusion criteria except they will 
not have had a head injury. All military TBI subjects will have enrolled in the NMVAHCS portion of the 
study prior to enrollment in the UNM portion.
 
Exclusion Criteria
Subjects will be excluded from participation in this study if there is 1) any history of moderate or 
severe TBI; 2) a prior history of other neurological disease or any history of seizures beyond 
immediate post-traumatic seizure, to as to reduce risk of exacerbation of epilepsy or other neurological 
symptoms; 3) history of psychosis, so as to reduce risk of psychiatric decompensation; 4) history of 
current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on 
cognition and plasticity; 5) any discontinuity in skull electrical conductivity (i.e., unhealed burr holes 
in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded 
electrical current; 6) presence of any implanted electrical device (e.g. pacemaker), to reduce risk of 
device malfunction; 7) recent medical hospitalization (within three weeks), to reduce risk of medical 
decompensation during the study; 8) any condition that would prevent the subject from completing 
the protocol; 9) appointment of a legal representative, as assessed via direct inquiry of the subject and 
a designated trusted other, to avoid coercion of a vulnerable population; 10) any significant blindness, 
to screen out peripheral sensory damage; 11) any significant deafness beyond mild hearing loss, to 
screen out peripheral sensory damage; 12) any ongoing litigation related to TBI, to prevent 
interference with legal proceedings; 13) any contraindication to MRI; 14) membership in an identified 
vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion.
5. Number of Subjects
120 subjects will be recruited in total: 80 patients with mild TBI will be recruited for the imaging + 
stimulation arm, while 40 non-TBI healthy controls will be recruited for the imaging-only group.  
Clark and colleagues found an effect size of Cohen’s d = 1.2 for tDCS to induce improvements in 
cognition.21 For our power calculations we will assume a more conservative effect size of d = 0.7 
which is consistent with a recent meta-analysis of tDCS effect sizes.18 With 40 tDCS treatment 
patients compared to 40 sham patients and an effect size of 0.7, we have 80% power to detect effects 
of active versus sham treatment in a two-sample t-test.
6. Study Timelines
The duration of an individual subject’s participation in the research may range up to 6 months. The 
duration anticipated to enroll all subjects is 4 years. The expected duration for the investigators to 
complete the study (complete analysis) is 6 years.
7. Study Endpoints

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Primary endpoints: change in score on the somatic subscale of the Neurobehavioral Symptom 
Inventory, Beck Depression Inventory-II, change in MEG activations, and Patient’s Global Impression 
of Change (PGIC) quality of life measure from time 0 to 6 months.
8. Research Setting
All testing, analytical, and research activities will take place at the Clinical Core, UNM Center for Brain 
Injury Recovery and Repair, and the Mind Research Network, both located in Domenici Hall.
The Clinical Core of the UNM CBRR is a state-of-the-art cognitive neuroscience research facility, 
specializing in neuropsychological testing, neurophysiological measurement, and noninvasive brain 
stimulation. It is led by two cognitive neuropsychologists and features a dedicated staff of 
psychometricians and research technicians to carry out all aspects of Core projects. This includes 
developing, implementing, and coordinating research and administrative procedures for the 
successful management of clinical studies; scheduling neuropsychological assessments, neuroimaging 
appointments, and treatment appointments; and ensuring regulatory compliance of study 
modifications, events, and audits.
Mind Research Network: MRN is a world-class research organization located in Albuquerque, New 
Mexico with state-of-the-art imaging and information technologies and services. MRN is 
headquartered in Pete and Nancy Domenici Hall on the north (medical school) campus of the 
University of New Mexico (UNM) and occupies 33,000 square feet of space. MRN staff includes 
approximately 100 employees, 20 graduate students, and 40 volunteers. Domenici Hall is also home to 
two state-of-the-art animal research facilities: UNM’s Biomedical Research and Integrative 
Neuroimaging (BRaIN) Center, a neuroimaging facility for basic studies of central nervous system 
pathophysiology in animal models; and UNM’s Neurobiology Research Facility (NRF). In addition, 
Domenici Hall provides all of the human research space for UNM’s Departments of Neurology and 
Psychiatry – both part of UNM’s Health Science Center (UNMHSC). Resource sharing and collaboration 
between UNM and MRN are encouraged by this proximity, as well as by joint academic appointments. 
Together, UNM and MRN form a unique neuroimaging center for advancing neuroscience research.
9. Resources Available
Principal Investigator
As a junior PI in the UNM Center for Brain Recovery and Repair, Dr. Quinn’s goal is to establish an 
independent NIH-funded research program in neurorehabilitative and neurostimulatory therapies for 
affective, behavioral, and cognitive sequelae of traumatic brain injury (TBI).  The current proposal 
represents an exciting opportunity for him to bring together several of his academic interests in one 
scientific endeavor.  Dr. Quinn has made the treatment of TBI the focus of his clinical work for the past 
several years, achieving board-certification in neuropsychiatry and behavioral neurology in 2012 and 
brain injury medicine in 2016, and establishing a neuropsychiatry clinic in the UNM Clinical 
Neurosciences Center in 2013 to better serve the undertreated population of TBI patients in New 
Mexico. Serving as the consultant psychiatrist for the University of New Mexico Hospital since 2009, 
Dr. Quinn evaluates patients admitted to the hospital to the neurological and neurosurgical services.  
As UNMH is the only Level 1 trauma center in the state, the vast majority of TBIs receive care at this 
institution, and Dr. Quinn treats many patients with post-traumatic amotivational, dysexecutive, 
disinhibition, and psychomotor syndromes resulting from damage to cortical-subcortical circuits.  He 
has followed these patients after their hospitalizations as well, and published several case reports 
highlighting theoretical and practical dilemmas in treating TBI. 
Dr. Quinn joined the UNM Electroconvulsive Therapy (ECT) Service in 2012 after becoming certified 
in ECT, and in 2013 became the consultant psychiatrist for the UNM Movement Disorders Clinic and 
their associated deep brain stimulation (DBS) team.  He established the UNM Transcranial Magnetic 
Stimulation Clinic in 2017. He has co-authored a review of longitudinal neuroimaging studies of ECT, 

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a review of psychiatric symptoms after DBS, and reported the first successful use of right unilateral 
ECT for catatonia in a patient with a deep brain stimulator.   
To assist him in carrying out the proposed research Dr. Quinn has assembled an experienced team of 
advisors. Dr. Stacey Harris-Carriman, is a board-certified physiatrist and attending physician in the 
NMVAHCS Polytrauma Clinic, who performs daily evaluations of TBI patients. Dr. Marom Bikson is an 
expert in high-definition transcranial direct current stimulation, and its mechanisms of action, and will 
provide key guidance regarding the application of this neurostimulatory technology. Dr. Michael 
Hoffer is a prolific researcher in the neurosensory symptoms of TBI, and will provide methodological 
and research design expertise.  Additional guidance will be provided by Dr. Andrew Mayer, who is 
expert in neuroimaging of TBI and methodological issues; Dr. Julia Stephen, who is the MRN MEG Core 
Director; Dr. Jessica Richardson, who has studied the use of individualized HD-tDCS electrode 
placement in stroke patients; and Dr. Tara Alvarez, who has designed and optimized virtual-reality-
based treatments for post-traumatic oculomotor dysfunction.   
Research Coordinator, TBN, 12.0 calendar months/1.0 FTE (Years 1-4) 
The Research Coordinator will be responsible for running of the protocol at MRN, UNM CBRR, and 
NMVAHCS. The research coordinator will work closely with Drs. Quinn, Harris-Carriman, Mayer, 
Stephen, Alvarez, Richardson, and Hoffer to conduct neurobehavioral and sensory system assessments 
including test scoring and the majority of the data entry. She/he will schedule assessments, and she/he 
will also schedule the imaging data acquisition sessions with the research MRI and MEG staff. She/he 
will be responsible for identifying and recruiting the participants, perform pre-scan screening 
procedures, conduct neurobehavioral assessments, test scoring, and data entry. This individual will 
assist the research assistant in maintaining the regulatory binders, screening database, adverse event 
logs, and minutes of meetings. She/he will also participate in meetings and conference calls. In 
performing these administrative and regulatory tasks, the RA will work under the supervision of Drs. 
Quinn and Harris-Carriman. 
Research Assistant, UNM, TBN, 6.0 calendar months/0.50 FTE (Years 1-4) 
The UNM Research Assistant will be responsible for running of the protocol at NMVAHCS. The research 
assistant will work closely with Drs. Quinn, and Harris-Carriman to conduct sensory system training 
and brain stimulation with HD-tDCS. She/he will be supervised by Drs. Quinn and Harris-Carriman 
during the administration of these therapies. She/he will schedule sessions, and will be responsible 
for identifying and recruiting the participants, performing data entry and scoring. This individual will 
assist the study coordinator in maintaining the regulatory binders, signed consent forms, and securing 
coded hard copies of completed test forms and electronic data. She/he will also participate in meetings 
and conference calls. In performing these administrative and regulatory tasks, the RA will work under 
the supervision of Drs. Quinn and Harris-Carriman. 
Data Analyst, TBN, 12.0 calendar months/1.0 FTE (Years 1-4) 
The Data Analyst will be responsible for data acquisition, storage, curation, statistical analysis, fidelity, 
and quality assurance at UNM, MRN, and NMVAHCS. The data analyst will work closely with Dr. Quinn 
and Dr. Harris-Carriman to analyze the MRI, MEG, behavioral, and demographic data, create automated 
analytical pipelines, troubleshoot performance issues in the data acquisition components of the 
protocol, conduct statistical analyses, and create data representations for conveyance in meetings, 
reports, and publications. The data analyst will draft, co-author, and edit manuscripts for publication, 
and participate in meetings and conference calls.
Neuropsychological Assessment Measures. The Core has a library of advanced neuropsychological 
tools, applicable to assessment of different aspects of recovery and repair following TBI.  The library 
is useful for subjects of different ages and severity of injury.  This library has novel, computer-based 
neuropsychological measures as well as traditional neuropsychological measures long utilized in 
neuropsychological research projects and recommended for specific clinical populations (e.g., TBI 

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NINDS Common Data Elements). The Core maintains an instrument bank of health-outcome measures, 
including state-of-the-art, computer-administered measures. 
2) NIH Toolbox: Assessment of Neurological and Behavioral Function.  The NIH Toolbox is a state-of-the-
art set of standardized instruments developed by NIH to enhance data collection and advance and 
accelerate the pace of discovery in neuroscience research. The NIH Toolbox is a recently developed set 
of brief, computerized measures of key neuropsychological functions appropriate for use throughout 
the lifespan (i.e., 3+ years old) and across diverse study designs and settings. 
Virtual Reality Eye-Tracking Devices: An Oculus Rift virtual reality head-mounted display outfitted 
with ISCAN eye-tracking sensors will be used to characterize oculomotor performance deficits (UNM) 
during assessments.
3) Transcranial Direct Current Stimulation (tDCS). A sponge-based tDCS system (NeuroConn: DC-
Stimulator MR) and a high-definition tDCS system (Soterix:  MxN tES) are available in the Core for 
investigators to use to modulate neuronal excitability. These are CE-certified medical devices for 
conducting non-invasive transcranial direct current stimulation (tDCS), alternating (tACS) or random 
noise (tRNS) current stimulation on subjects, capable of delivering stimulation through diverse 
montages for sophisticated current steering. Both devices are equipped to deliver current through a 
variety of electrode shapes and sizes, with options for double-blind administration, and use in 
magnetic resonance imaging scanners. 
Data and sample collection. The Core will provide expert neuropsychological and 
electrophysiological assessment technical support. This will include providing testing rooms, 
neuropsychological tests and supplies, laptop computers, electroencephalography, and 
neuropsychology technicians/ psychometricians, as well as data entry and storage.  Core staff will 
assist the investigators with scheduling of assessments, neuroimaging, and treatment appointments. 
The Core will provide space for interventions being studied as part of this research project. 
Neuropsychological assessment batteries will be administered by Core psychometricians under the 
supervision of the Core co-directors. Neuropsychological test data will be scored by the 
psychometricians, with scoring reviewed for accuracy by the supervisors. A neuropsychological test 
summary prepared by technicians and reviewed by the supervisors will be provided to investigators, 
participants, and referral sources if indicated. If requested, Core co-directors will also provide 
feedback to participants regarding neuropsychological assessment results. Participant hardcopy data 
will be stored in locked file cabinets in locked rooms within a locked, security-patrolled building. For 
analysis, participant data will be entered and stored in COINS, a web-based electronic data capture 
platform that is secure and HIPAA compliant available on the MRN server. Neuropsychological data 
will be entered by psychometrists into study databases with accuracy verified by double entry.
3T MRI and the Elekta Neuromag MEG are housed immediately proximal to the neuropsychological 
testing rooms, as part of the MIND Research Network (MRN) advanced biomedicalimaging core.  The 
imaging facilities have private changing rooms with lockers for personal items.
Should patients require any medical or psychological care as a consequence of participation in 
research, UNM Health Sciences Center is located immediately proximal to the CBRR and Mind Research 
Network and can provide basic to advanced care 24 hours a day, 7 days a week.
10.
Prior Approvals
Departmental Approval form included.
11.
 Multi-Site Research

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Plans for communication between the collaborating institutions: Dr. Quinn and Dr. Harris-
Carriman will be the head of an Administration and Oversight committee that will consist of study staff 
and collaborators. They will communicate regularly by e-mail, weekly by conference call with the study 
coordinator, and in-person at an annual study meeting. The Administration and Oversight component 
will monitor progress in all aspects of the project and discuss issues concerning 
recruitment/enrollment, data collection/analysis/entry, preparation of papers and technical 
problems. This group will also be responsible for oversight of the project, including compliance with 
ethical guidelines for conduct of human research as regulated by HIPAA and institutional review 
boards (IRBs), conferring regularly with their project staff to ensure that recruitment and data 
collection are carried out according to the standardized project protocols and that data are transferred 
to the research coordinator in a timely manner for entry into the study database. This committee will 
also be responsible for ensuring that all sites have the most current version of the protocol, consent 
document, and HIPAA authorization; that all required approvals have been obtained at each site, that 
all modifications have been communicated to sites, and approved by each site’s IRB of record. Any 
noncompliance with the study protocol will be reported by the PI to the study IRBs of record, as well 
as the USAMRMC IRB.
Data Safeguarding: Dr. Quinn will manage neuropsychological, demographic, and sensory data entry 
at UNM. Oversight for imaging data collection and analysis at MRN will be performed by Dr. Stephen 
and Dr. Mayer. Overall data quality assurance will be conducted by Drs. Quinn and Harris-Carriman. In 
addition, Dr. Quinn will analyze imaging, cognitive, behavioral, and sensory data, and brain stimulation 
data from the two sites at least once a month to guarantee that procedures remain consistent 
throughout the grant period. Drs. Quinn and Harris-Carriman will monitor subject enrollment and 
address issues that arise. They will communicate by email and telephone weekly and as needed, at 
which time enrollment will be reviewed so that inclusion/exclusion criterion are observed 
consistently over all recruitment sites. The secure, password-protected, firewall-protected MRN 
server will be used to store data from the study sites, including the demographic, neuropsychological, 
and neuroimaging information collected by individual MRN/University of New Mexico (UNM) 
investigators during the course of IRB-approved human research. All research data collected in this 
server is coded with random subject identifiers. If a participant grants permission, this information 
may be used for unspecified future research. The database is stored on a secure network at MRN and 
access is password protected. 
Standardization of Study Procedures Across Sites: All consenting, cognitive, sensory, behavioral, and 
clinical measures will be standardized across study staff at CBRR. MRI and MEG scanning will take 
place at the adjacent MRN, physically located within the same building as CBRR. 
Our assessments will follow NINDs recommended Common Data Elements (CDE) and the data protocol 
currently proposed. In regards to neuroimaging, the same MRI and MEG scanners will be utilized 
throughout the study, with protocoled procedures for obtaining necessary sequences. At initial grant 
funding, Dr. Quinn and Dr. Harris-Carriman, in consultation with Drs. Mayer, Stephen, Alvarez, Hoffer, 
and Richardson, will write standardized project protocols for recruitment (inclusion/exclusion 
criterion), consenting, screening, administration of brain stimulation and training, administration of 
cognitive, behavioral, and clinical measures, MRI and MEG safety screening, MRI and MEG data 
acquisition, neuroimaging data processing and analyses, and data entry. The research coordinator, 
postdoctoral fellow, and research assistants will be jointly trained in
these standardized project protocols by study investigators. 
Real-time communication will be assured by having all investigators and research staff carry cellular 
phones, with access to all contact phone numbers. They will all agree to be available to answer phone 
calls from other team members, and if a call is missed, agree to call back within a three-hour time-
window.
Plans for data transfer between the collaborating institutions: Appropriate Data Transfer Agreements 

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will be established according to institutional guidelines of UNM/MRN, and NMVAHCS, and approved 
by each local IRB. Consent forms for this UNM study will clearly document a participant’s permission 
to store and share any data obtained during the course of the study. Only IRB-approved study 
personnel will have access to any data collected during the course of this study. 
12.
 Study Procedures
Experimental Design and Methods
     
Participants:  120 subjects will be recruited for this study, 40 healthy controls subjects for the imaging-
only group, and 80 mTBI subjects for the stimulation arm who have suffered mild TBI at least 3 months 
prior to study enrollment, but not more than 20 years prior to enrollment.  All participants will be 18-
69 years of age.  We will expect to screen approximately 200 patients with mTBI in order to reach our 
goal of 80 TBI subjects. Recruitment of civilians will be overseen by UNM and recruitment of military 
subjects will be overseen by the NMVAHCS IRB.
Recruitment:   Recruitment of civilians will occur via flyers, clinician referrals, and word of mouth. 
Military participants (ages 18-69) enrolled in the study protocol at the NMVAHCS will automatically 
be invited to come to the UNM CBRR to ask questions prior to providing consent (for UNM part of 
protocol).  Healthy control participants will be invited to UNM CBRR to ask questions and complete 
consent if interested in participating. They will be provided with consent forms that describe the 
study procedures and potential risks in great detail.  If participants are unsure about participation, 
they will be given our contact information and be invited to call if they decide to participate.Once 
UNM CBRR informed consent is obtained and the appropriate forms signed, the participant will be 
assigned a unique research subject identifier (URSI) number, and from that point forward all 
research data will only be labeled with the URSI number.  The key linking identifiers of participants 
to the URSI will be maintained on a separate database that will be stored behind locked doors, in a 
locked filing cabinet in a secure area of the CBRR, and on the UNMHSC secure server. 
If public health conditions require in-person research encounters be minimized some of the above 
outlined recruitment procedures may be conducted over the phone.  The following outlines phone 
recruitment procedures:
Military and healthy control participants (ages 18-69) enrolled in the study protocol 
at the NMVAHCS will automatically be called so that they can ask questions prior to 
providing consent (for UNM part of protocol).  After discussing the study and asking 
questions, potential participants who complete screening and are eligible for 
participation, will be mailed or emailed the consent form that describes the study 
procedures and potential risks in great detail.  Participants will be given our contact 
information and be invited to call if they decide to participate.  If they decide to 
participate, a consent phone call will be conducted in which the consent form is 
reviewed, the participant can ask questions, and if interested in continuing 
participation, the Consent Form Quiz will be completed (over the phone).  If they are 
successful with the quiz, they will be scheduled for their first visit.  
Consent form signature will be done in person, at their first visit, so that it can be 
witnessed and signed by research staff.  Once informed consent is obtained and the 
appropriate forms signed, the participant will be assigned a unique research subject 
identifier (URSI) number, and from that point forward all research data will only be 
labeled with the URSI number.  The key linking identifiers of participants to the URSI 

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will be maintained on a separate database that will be stored behind locked doors, in 
a locked filing cabinet in a secure area of the CBRR, and on the UNMHSC secure 
server.All participants (both TBI and healthy control; military and civilian) may then undergo 
baseline demographic data collection, neuropsychological assessments sensory evaluation, at UNM 
CBRR. They may also undergo MEG and MRI at the Mind Research Network, located in the same 
building as CBRR. 
The TBI intervention group (military and civilian) will then undergo HD-tDCS and sensory training 
sessions, which will be delivered over 10 days at UNM CBRR. They will then repeat all testing and 
assessments that were performed during the baseline visits.
Long-term follow-up will then be performed at 1, 3, and 6 months for the intervention group.  For 
military TBI participants, this will be overseen by the VA IRB. For civilian TBI participants, this will be 
overseen by UNM.
All assessment items with an asterisk may be over the phone or sent to the participant to complete if 
public health conditions require in-person research encounters be minimized.  Consent will be 
obtained prior to any study activities.
*Demographic Data: As part of the initial assessment, basic demographic data regarding the subject 
may be noted down, including age, gender, socioeconomic status, educational attainment, medical and 
mental history, handedness, use of common stimulants such as caffeine, and brain injury severity. They 
may also be asked if they are willing to allow their medical record to be accessed, for the purposes of 
confirming details about any TBI as well as obtaining results of neuroimaging studies done at the time 
of injury or afterward.   This will include medical, surgical, neurological and psychiatric history, results 
of lab tests, brain scans, electroencephalography tests, medication lists, information from doctor’s 
visits and hospital visits.  
TBI Diagnosis: will be assessed using:
*Combat Exposure Scale
*Glasgow Outcome Scale
*Ohio State University Identification Method
*Walter Reed Army Medical Center Blast Injury Form
Behavioral Symptoms: will be assessed using:
*Defense and Veterans Pain Rating Scale and Supplement 
*Neurobehavioral Symptom Inventory
*PTSD Checklist – Military Version
Quality of Life will be assessed using: 
*Patient’s Global Impression of Change 
*Community Integration Questionnaire
*Promis 29
Neuropsychological testing procedures: All neuropsychological testing will be administered in the 
Center for Brain Recovery and Repair Core by trained study personnel under direct supervision of core 
directors, clinical neuropsychologists Drs. Yeo, Campbell, or the PI. The primary dependent outcome 
variable to be studied is the somatic subscale score on the NSI. The following domains and tests will 
be administered:  
Digit Span Hopkins Verbal Learning Test (HVLT)); 

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Test of Memory Malingering (TOMM); 
Test of Premorbid Functioning
Trail Making A and B
NIH Toolbox Assessments
Handedness; 
Sensory Assessment: Hearing, balance, and vision will be assessed using CDE instruments:
Vision:
Convergence Insufficiency Symptom Survey (CISS)
Oculomotor Assessment Tool
Visual Acuity (Snellen Chart)
Oculomotor control will be assessed using virtual reality goggles (Oculus DK) with implanted eye 
trackers (iScan).
Hearing:
Hearing Handicap Inventory
Audiometry
SCAN-3 A
Tinnitus Handicap Inventory
Balance
*Dizziness Handicap Inventory
Neurosensory Assessment
Magnetoencephalography: Magnetoencephalography (MEG) may be done after neuropsychological 
testing. The participant will sit in the MEG scanner to record brain magnetic fields. MEG setup takes 
between 10 and 30 minutes, and subsequent recording takes one to two hours.  During MEG 
assessments participants will complete numerous active tasks.   Each task is designed to parse different 
cognitive mechanisms that contribute to sensory performance.  In perceptual tasks, participants will 
discriminate tone pitches amongst novel distracting tones.  For eye movement tasks, participants are 
asked look either towards or away from a visual stimulus. 
Magnetic resonance imaging:  Structural MRI scan(s) will be obtained for integration with MEG, as 
needed for MSI analyses. Total scan time, including participant setup and removal, is expected to take 
30 minutes to 1 hour. Participants may lie down on a table and be placed into a long donut-shaped 
magnet. During the scan, participants will be asked to rest quietly or to fixate on a dot on a screen in 
front of them. In visual decision making tasks, participants are required to classify stimuli based on 
pre-determined types of rules.  No contrast will be used. Any female over 18 will complete a urine 
pregnancy screen before the MRI scan. Results of pregnancy screens will be kept strictly confidential 
as per MRN policy. Urine samples will be disposed of immediately after testing. 
Left DLPFC anodal HD-tDCS Intervention (Visits #3-12): All TBI participants (military and civilian) will 
receive either active or sham anodal HD-tDCS to the left DLPFC for a total of 30 minutes each day for 
ten consecutive weekdays at the University of New Mexico Center for Brain Injury Recovery and 
Repair.  Current will be ramped up over 1 minute at initiation and ramped down over 1 minute with 
termination. The choice of anodal stimulation was based on our preliminary data and reviewed 
literature.   A longer period of stimulation (2 weeks instead of 1 week) was selected based on 
evidence that repeated stimulations in close succession result in longer-lasting effects in healthy 
controls, stroke, and depression, with observed effect up to three months afterward.  A Soterix 9-
channel high-definition transcranial electrical stimulator system will be used to administer HD-tDCS 
current. Targeting of the left DLPFC (F3 position, International 10-20 system of EEG coordinates) will 
be done by utilizing a standard EEG cap fitted snugly to the subject’s head.  Round, 1 cm2 HD-tDCS 

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electrodes will be utilized to deliver anodal current and receive cathodal current. Two anodal 
electrodes will be placed on the scalp over the DLPFC, delivering approximately 1 mA of current 
each, to reduce overall sensation. Up to 6 cathodal return electrodes will be placed in cardinal 
positions around the anode.  Current for the treatment condition will be applied at 2.0 mA for 30 
minutes for a total delivered charge of 60 mA-min.  UNM Co-investigator Dr. Davin Quinn will train 
the research technician and/or the research coordinator to administer the HD-tDCS.
Double blind design and sham treatment: The sham stimulation (control) group will receive 0.5 mA 
current for 30 minutes each session with a 1 minute ramp at the beginning and end of treatment.  The 
0.5 mA current is used as a control condition, rather than the absence of stimulation, to equate aspects 
of the procedure (preparation and application of electrodes), and to give the participant a degree of 
physical sensation that is somewhat like that of the 2.0 mA stimulation group while remaining well 
below the level sufficient to affect brain function and behavior. To accomplish a double blind, the HD-
tDCS machine is programmed to randomize sham versus active stimulation and keeps track of the 
stimulation protocol for later querying. 
Sensory Training Tasks (Visits #3-12): For all groups, participants will be administered the sensory 
training battery for 30-45 minutes, during treatment and sham. While there are multiple sensory 
modalities that could have been targeted with training, the auditory, visual, and vestibulo-oculomotor 
systems are the most implicated in PCS. Session procedures will begin with HD-tDCS electrode 
placement while seated in a comfortable chair. After initiation of HD-tDCS, the first half of the training 
is a set of vision therapy exercises for convergence insufficiency symptoms after traumatic brain 
injury, devised and validated by Consultant Alvarez and her colleagues.  It is delivered via computer 
with an Oculus Rift virtual reality headset outfitted with eye-tracking sensors.  The exercises consist 
of 1) disparity vergence steps, where two visual images are presented and the subject attempts to fuse 
the images by converging with their eyes; 2) disparity vergence ramps, using images moving smoothly 
inward or outward the subject must focus on; and 3) saccadic stimuli, where subjects are asked to look 
at visual stimuli in the periphery. These tasks activate a consistent brain network involving nodes of 
the CCN (DLPFC), frontal eye fields, parietal, cerebellar, and midbrain nodes that is implicated in 
convergence insufficiency.  Thus this task is well suited to pairing with HD-tDCS to activate CCN circuits 
associated with the vestibulo-oculomotor system.
During the second half of the experiment, subjects will perform our dual visual/auditory n-back task 
that specifically loads onto CCN circuits in the DLPFC mediating working memory, and has been 
utilized in our current tDCS trial (Quinn et al, in preparation). In the dual n-back, subjects are asked to 
look at a sequence of squares displayed on a computer screen, one at a time, in different areas.  They 
must press a button if the current square matches the location of the square from 1, 2, or 3 instances 
previous. At the same time, a computer-generated voice is stating a string of numbers, one at a time. 
The subject must also respond with a button press if the current number matches the number from 1, 
2, or 3 instances previous. Cognitive load increases as subjects are asked to go from 1, to 2, to 3-back 
in the task, trying to hold both locations of squares as well as stated numbers in working memory. 
Post stimulation testing:  the next available weekday following completion of the intervention, subjects 
will return to UNM CBRR to repeat the demographic, neuropsychological, sensory, and imaging 
assessments.  Participants and research staff will also complete an exit questionnaire after the 
completion of all assessments and testing.
COVID-19 Assessments
Depending on public health guidelines, participants may complete the following assessments:
Prior to any study visit and upon arrival for visit, participants may complete via text or phone call, the 
Participant COVID-19 Symptom Checklist to assess for any symptoms of COVID-19.  If any symptoms are 
endorsed, the PI will be notified, and the study visit may be cancelled. 

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The CoRonavIruS Health Impact Survey (CRISIS) V0.3: Adult Self-Report Baseline Current Form 
may be used to assess participant’s anxiety related to COVID-19.  The demographic questions on this form 
will not be administered. 
Long term followup: At 1 month, 3 months and 6 months after stimulation, military TBI subjects will 
complete the PCL-M, the NSI, Promis-29, and PGIC quality of life assessment tools at the NMVAHCS or 
via telephone.  This will be overseen by the NMVAHCS IRB. Civilian TBI subjects who are enrolled in 
the study will complete these follow-ups at UNM CBRR or via telephone.  This will be overseen by the 
UNM IRB.  
13.
Data Analysis
All data will undergo standard preprocessing (e.g. motion correction, spatial normalization) and 
quality control prior to statistical modeling. Depending on the specific question of the study, data 
may be analyzed using the general linear model, independent components analysis, machine learning 
techniques, or a variety of other standard approaches for neuroimaging data. Drs. Mayer, Stephen, 
and Alvarez are skilled in analysis of the various behavioral data, sensory performance, MEG and MRI 
sequences and will assist the PI in analysis of the data.
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects
Data safety and monitoring will be carried out to ensure and maintain the scientific integrity of this 
project and to protect the safety of our participants.  Safety monitoring is the process during the 
study that involves review of accumulated outcome data for groups of subjects to determine if any of 
the procedures practiced should be altered or stopped.  Ultimately, the PI (Quinn) will be responsible 
for monitoring the safety of the study and complying with the reporting requirements. An 
independent study monitor, Dr. Christopher Abbott and Sarah Pirio Richardson (Appendix A) , will 
review the study data on a quarterly basis with the co-PIs to ensure participant safety. Dr. Abbott is a 
board-certified psychiatrist and NIH-funded clinical investigator in the use of neuroimaging to 
evaluate mechanisms of action of electroconvulsive therapy, and is thus a highly qualified person to 
serve as the independent study monitor. Continuous, close monitoring of participant safety will 
include prompt and frequent reporting of safety data (i.e., adverse/serious adverse events) to the 
monitor, the University of New Mexico Health Sciences Center Institutional Review Board (UNMHSC 
IRB) and the USAMRMC staff with oversight responsibility.  The PI will provide a summary of the safe 
conduct of the study to USAMRMC on an annual basis as part of the progress report.  All AEs 
occurring during the course of the study will be collected, documented, and reported to the UNMHSC 
IRB.  
The review of data may result in early termination of the study, amendment to the protocol, or 
changes to the data collection plan or study forms if it appears that there are adverse events 
occurring at a rate significantly greater than that found in similar tDCS studies involving subjects 
with neurological disorders (ie. stroke).  Should the protocol or data collection plans or study forms 
be amended as a result of data review, the IRB will be notified and the amendment approved prior to 
study amendment implementation.  Any substantive changes to the protocol, such as a change in PI, 
change or addition of an institution, elimination or alteration of the consent process, change to the 
study population that has regulatory implications (e.g. adding children, adding active duty 
population, etc), significant change in study design (i.e. would prompt additional scientific review) or 
a change that could potentially increase risks to subjects, will also be submitted to the USAMRMC 
IRB. In addition, the participants will be notified of any significant new findings that develop during 
the course of research that may affect their wish to continue participation in the study. 
15.
Withdrawal of Subjects

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If at any time a participant wishes to withdraw from the study, they will be debriefed by the 
study coordinator or principal investigator as to the reason for their withdrawal. They will be 
offered the chance to partially withdraw from the stimulation protocol and continue in the 
data collection aspect if they so wish.  Otherwise the participant will then be thanked for their 
time, and they will be compensated for the extent of their participation.  
If the participant wishes to withdraw, they will be asked if they will allow data already 
collected on them to be used in the study analysis.  If not, the data associated to their 
identifying code will be purged from the study database.
16.
Data Management/Confidentiality
Questionnaire Data: All data are coded with a unique research subject identifier (URSI) number.  
Electronic data is stored on a drive only accessible by the research team on a secure MRN server, 
and/or in the COINS database on a secure HIPAA compliant cloud based server.  For non-
computer based forms, such as the neuropsychological assessments, the data collection sheets are 
stored in a locked cabinet in a locked office at MRN.
Behavioral and Imaging Data: All data are coded with a unique research subject identifier 
(URSI) number.  Electronic data is collected and stored on a drive only accessible by the research 
team on a secure MRN server, and/or in the COINS database on a secure HIPAA compliant cloud 
based server.
Neuropsychological testing, sensory testing, and questions regarding demographics, medical and TBI 
history, postconcussive symptoms, and quality of life, and neuroimaging will be recorded on to paper 
and pencil or computerized data forms that do not contain identifying information, and will only be 
marked with the subject’s URSI. A separate file contains contact information for the purpose of 
providing the radiology review letter and future contact, if needed, but has no personal data or 
protected health information that is collected as part of the study.
No personally identifying information will be coded on the questionnaires, neuropsychological 
measures, brain imaging data, or any other data recording instruments, assuring confidentiality to 
the best of our ability. Subject identification numbers are assigned to each participant.  Only the PI 
and HIPAA-trained project coordinator have access to the file that links names with subject numbers.  
All data are stored in locked file cabinets in a locked office, and on password-protected computers 
located behind a secure and maintained firewall.
All data are collected by the PI, or trained research assistants who have completed on-line training in 
human subjects’ research, HIPAA and research integrity; who are trained in our lab on research data 
management and confidentiality; and who are trained to criterion on project protocol. Data will be 
collected specifically for this proposed research project.
Participants will be assured that all records will be kept confidential in research files located in a 
locked office and entered into a password-protected computer located behind a secure and 
maintained firewall. Breach of confidentiality is highly unlikely because all personally identifying 
information will be kept separate from data collected, and will be linked only by a master subject 
identification list maintained by the project coordinator and PI.  
In order to address any concerns regarding coercion, participants will be informed that they are free 
to choose not to participate and may withdraw at any time (this is included in the consent form). 
Finally, because any information gathered as part of this study is confidential, we cannot intervene on 
an individual level unless it is discovered that there is imminent threat to the life of the participant, to 
others, or if there is any indication of child or elder abuse.  In these rare cases, we would consider the 
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themselves (i.e., talk with the participant and express concern, present the participant with local 
options for treatment, encourage him/her to disclose the issue to authorities, and if unwilling, inform 
them that we must disclose the information to authorities for their (or others’) safety.
We will also provide all participants and their families with a referral list of community support, 
treatment, and educational resources about TBI.  This information will also be explained during the 
consent process. In addition, if a participant’s status with respect to any of the study criteria change 
during the experiment (i.e., initiation of substance abuse), the participant’s participation in the study 
may be terminated without their consent.  Our consent form will include a statement regarding 
anticipated circumstances under which the subject’s participation may be terminated by the 
investigator without regard to the subject’s consent and a statement indicating that significant new 
findings developed during the course of the research which may relate to the subject’s willingness to 
continue participation will be provided.
Data collected from participants in this study will be shared with FITBIR Informatics System.  The 
Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System is a central 
repository and resource for sharing data that was developed by the Department of Defense (DOD) 
and the National Institutes of Health (NIH) to promote collaboration, accelerate research, and 
advance knowledge on the characterization, prevention, diagnosis and treatment of traumatic brain 
injury (TBI). FITBIR provides a common platform and standardized format for data collection, 
retrieval and archiving, while allowing for flexibility in data entry and analysis. Additional 
information and detailed implementation guidance related to the FITBIR Informatics System can be 
found at http://fitbir.nih.gov (FITBIR Data Sharing Policy, 2017).  All links to identifiers will be 
removed from the data before it is shared. Only de-identified data which does not include any direct 
identifiers that might directly identify you will be shared with FITBIR users and the general scientific 
community for research purposes (FITBIR Data Sharing Policy, 2017).  Rakib Zaman 
(Rakib.zaman@publicissapient.com) is this study’s contact at FITBIR Informatics Systems.  His 
official title is “FITBIR Operations”.
Statistical analyses will utilize the CTSC Biostatistics core.  Power analyses and statistical analysis 
strategy were determined with our statistician Dr. Orrin Myers, who will continue to provide 
recommendations and support throughout the project.  For Aim 1, the central analyses evaluate 
group (active vs. sham) differences in the MEG data and on the three Examiner composite variables 
across the three initial time points (before, immediately after, and 1 month after tDCS stimulation 
protocol). To test this hypothesis, three separate linear mixed models analyses will be performed 
using the three Examiner composite scores (Fluency, Cognitive Control, Working Memory) as 
dependent variables. In each analysis, we will incorporate three covariates that may predict variation 
in learning (depression: BDI score, premorbid intelligence: WTAR score, and symptom burden: NSI). 
This will allow us to determine predictors of treatment response. Sex, ethnicity, and age will also be 
entered into the statistical model. The effects of these covariates will be estimated by constructing 
appropriate contrasts in model effects. A similar set of analyses will evaluate group differences on 
the variables assessed in our long-term oral/phone follow-up (five data points: (1) before tDCS, (2) 
immediately after tDCS, (3) 1 month, (4) 3 months, and (5) 6 months. For these analyses dependent 
variables will be the total sensory items score of the NSI). Significant effects will be followed up with 
more fine-grained analysis of the components of composite scores. The use of linear mixed-models 
minimizes the adverse impact of a missing data point, which may well occur in a longitudinal clinical 
study such as this.  Expected attrition will be taken into account with an intention-to-treat 
analysis.  Missing data patterns will be analyzed to assess the extent to which they are informative (in 
contrast to missing at random), and analyses adjusted accordingly.  All MEG data will undergo 
standard preprocessing (e.g. motion correction, spatial normalization) and quality control prior to 
statistical modeling. Depending on the specific question of the study, data may be analyzed using the 
general linear model, independent components analysis, machine learning techniques, or a variety of 
other standard approaches for neuroimaging data. 

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Data will be stored in Excel spreadsheet form as well as on hard copies.  
Digital data will be stored on secure encrypted drives located behind a secure firewall.  Data 
will be reviewed by the PI for quality control.
No data will be collected, transmitted, and/or stored via the internet. No data will be collected 
via audio/digital recordings. No data will be collected on video recordings or via photographs. 
Data will be stored for the duration of the study and will be destroyed after the final data 
analysis is complete.  It will be stored at the Clinical Core on secured encrypted drives (digital) 
and in locked file cabinets behind locked doors in a secure area of the Clinical Core.
A Certificate of Confidentiality (CoC) has been received for this study.  The CoC helps the 
researchers to protect the privacy of the subjects enrolled in the study from compulsory legal 
demands, such as court orders and subpoenas, for identifying information or identifying 
characteristics of a subject.  This study is eligible for a CoC because it will collect personally 
identifiable, sensitive information about subjects, and will be federally funded.  Sensitive 
information in this study includes information about a subject’s neuropsychological 
performance and emotional states.  This is information that if released could be damaging to 
a subject’s financial standing, employability, or reputation within the community; pertains to 
a subject’s psychological well-being or mental health; and might lead to social stigmatization 
or discrimination if it were disclosed.   
17.
Data and Specimen Banking 
N/A
18.
Risks to Subjects
Participation in this study for mild TBI subjects may involve minor risks and/or discomforts associated 
with possible breach of confidentiality risk, neuropsychological testing, sensory testing, MRI, and MEG.  
MRI: Radio and magnetic waves associated with MRI scans are not associated with any known adverse 
effects. MRI is non-invasive and considered minimal risk by the FDA and OHRP. However, the scanner 
is a large magnet, so it could move objects containing ferrous metal in the room during the scan.  All 
control and mmTBI participants are screened using the MRI safety screening form prior to be being 
scanned.  Participants with any MRI scanning contraindications will be excluded from study 
participation.  Participants may be bothered by feelings of claustrophobia (uncommon). The MRI also 
makes loud ‘drum’ beating noises during the study.  There is a small risk that the MRI procedure may 
increase anxiety for participants who have post-traumatic stress disorder, Headphones are provided 
for protection. Rarely, large tattoos can heat up during an MRI scan and cause skin irritation like a 
sunburn (uncommon). No long-term harmful effects from MRI are known. However, since the effect of 
MRI on early development of the fetus is unknown, participants who are pregnant will not be allowed 
to go in the MRI. Females 18 years of age or older who suspect they may be pregnant will be asked to 
take a urine pregnancy test before being allowed to participate in the study. The test results will only 
be shared with participant. 
MEG:  The laboratory stimuli used in the current experiments are neither physically nor emotionally 
intense. The MEG recording procedures involve no pain or invasive techniques. The primary risk to 
the subjects during the MEG exam is discomfort from sitting still for approximately 90 minutes, or due 
to discomfort from electrodes on the scalp of the head or on the skin of the face. MEG itself is entirely 
noninvasive and only measures the signals naturally being generated by the activity in one’s brain. 
There are no known health risks associated with the proposed MEG studies. A two-way intercom 
system and a video monitoring system provide continual monitoring of the subject’s condition. If 
discomfort or concern is expressed or detected, the experiment will be stopped and the subject will be 
given the option to discontinue at any time.

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Neuropsychological tests.  The neuropsychological tasks involved in the protocol entail no foreseeable 
risk, besides perhaps fatigue or mild to moderate demands on attention and cognition. These are 
typically very marginally significant risks, mitigated by the fact that if a patient fatigues during testing 
they are given a rest break or are rescheduled.  There is also mild psychological risk inherent in testing 
participants for cognitive abilities.
One potential risk is breach of confidentiality related to collection of sensitive information.  
Confidentiality issues are significant since this study collects a variety of sensitive data, in particular 
with respect to substance use. Because personal information is gathered, there exists the risk of 
possible invasion of privacy. However, our hard copy data is stored in locked cabinets in locked rooms 
within a locked, security-patrolled building; and there has never been a breach of confidentiality in our 
lab. Hence we believe that the likelihood of invasion of privacy is minimal. 
Sensory testing:  Participants may experience mild “motion sickness” or headache while using the 
virtual reality goggles to assess oculomotor control. Some participants may experience nausea, 
vomiting, or increased headache when performing sensory testing.
MEG: There is a very small possibility that participants with sensitive skin (e.g., contact dermatitis) 
may experience some skin irritation from the gel or sensors used for monitoring heartbeat and eye 
movements. (uncommon).  There may be fatigue or restlessness associated with undergoing MEG. 
Subjects will be allowed to take breaks as needed during scanning.
Special Precautions
Subjects will be asked about any changes to medications or use of recreational substances or changes 
in eating/drinking habits at each assessment point. At study enrollment subjects will be asked to keep 
their medication use constant between the assessments, unless changes are medically recommended 
during that time, and that they should alert study personnel to any changes in their medications during 
the study period. Subjects will be asked not to smoke cigarettes or drink coffee 1 hour prior to arrival 
for testing, and that they should bring any and all assistive devices or wearable prosthetics with them 
to study appointments, including hearing aids, glasses, contact lenses. Women of child-bearing age will 
be asked to use two forms of contraception between pre- and post-stimulation assessment for 
pregnancy prevention. Subjects will be advised to avoid further head injuries while enrolled in the 
study, and to notify study personnel of any new injuries or other medical symptoms.
No special care or special equipment is needed for the subjects to be enrolled in the study.
Safety of stimulation (Visits #3-12). 
A Data Safety and Monitoring Board (DSMB) will review study data with the PI quarterly for any side 
effects or adverse events.  There are several risks associated with HD-tDCS treatment and sham 
procedures, however, based on our experience with this technology (3 current IRB-approved studies 
at UNM ongoing) we believe that these risks are minimal (Bikson et al, 2016). Common expectable side 
effects during HD-tDCS include skin redness, itching sensation, mild fatigue or drowsiness, nausea, and 
headache. 
All patients undergoing stimulation with HD-tDCS will be asked to rate their discomfort with these 
symptoms every ten minutes, and the treatment will be stopped if discomfort rises above 7 on a 10-
point anchored Likert scale, if mood is lowered to a rating of 2 or less, or at any time the patient wishes 
to stop. All efforts will be made to reduce subject discomfort and avoid the rare occurrence of skin 
burns, including evidence-based techniques such as using gel with HD-tDCS electrodes; offering 
emollient cream for reddened areas following stimulation; cleaning all electrodes regularly; not 
stimulating over skin with lesions or dermatologic conditions; checking skin impedance before 
stimulation. When these precautions are followed with conventional HD-tDCS protocols (i.e., 1-2 mA 
stimulation for up to 30 minutes), using optimized safety protocols, significant adverse effects, such as 

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burns on the skin near electrode affixation or heating of the electrodes affecting nearby scalp surface 
have not been reported. 
In HD-tDCS, small circular electrodes with conductive gel are used to administer the current, which 
protects the scalp from irritation. Additionally, since more than two electrodes are used less current 
passes through each electrode, making slightly higher (e.g., 2mA) current strengths more comfortable. 
Multiple studies of HD-tDCS in patients with chronic pain, stroke, and tinnitus have demonstrated no 
differences in heart rate, blood pressure, or participant ratings of discomfort during treatments, no 
increased sensations compared to conventional sponge tDCS, and no adverse events.  (Shekhawat et 
al, 2016, Richardson et al, 2015, Castillo-Saavedra et al, 2016)
 
Precautions taken in this study include monitoring mood with visual analog scales during stimulation, 
and pre/post-treatment depressive symptom questionnaires. There has not been a reported instance 
of suicidality caused by tDCS. In healthy controls there have been no reported adverse events of HD-
tDCS, other than the physical sensations and skin irritation above. Of critical importance is the safety 
of HD-tDCS in patients with neurological illnesses that may carry some increased vulnerability to 
either brain damage or seizures. The experimental threshold at which tDCS causes brain injury was 
found to be two orders of magnitude above the current densities used in humans, making stimulation 
at the scalp with contemporary protocols causing brain damage extremely unlikely. tDCS is used in 
post-stroke patients in protocols that place the stimulating electrodes ipsilateral to the lesion and 
very often close to perilesional areas, without any increased side effects or adverse consequences 
(Richardson et al, 2015). Even more reassuring, tDCS at 1.0-2.0 mA has been performed over damaged 
left frontal cortex in 37 patients with moderate to severe TBIs, who are at the highest risk of post-
traumatic seizures and demonstrate the greatest levels of structural damage, without adverse events, 
seizures, or decrements in neurologic status.(Li et al, 2016) A review of and contact with studies 
registered in clinicaltrials.gov for tDCS in TBI (Spaulding, NYU, U. Leige) did not discover any 
occurrence of seizures or adverse events. 
COVID-19 Study Precautions
Study procedures may be amended based on UNMHSC, HRPO, state public health office, or federal 
regulations to minimize risk of infection.  The following safety measures may be performed when 
appropriate:  

When possible, assessments that can be completed without research staff support may be 
sent to the participant to complete offsite (see Section 12)

Participant screening will continue to be completed by phone. 

Prior to each participant visit and upon arrival at a visit, a research staff member may call or 
text prior to the scheduled participant visit or ask participant upon arrival questions to 
assess for COVID-19 symptoms.   The “Participant COVID Symptom Checklist” will be used to 
assess for such symptoms.  If any symptoms are endorsed, the PI will be notified, and the 
participant visit may be cancelled. 

Prior to arriving at work, staff may be required to complete the “Staff COVID Symptom 
Checklist”.  If any symptoms are endorsed, the PI will be notified, and the staff member may 
not work onsite until symptoms have resolved. 

During in-person research visits, the following precautions may be taken:
o
Social distancing (6’)
o
Reducing the number of people in an exam room to no greater than 2 at a time
o
Include a barrier between research personnel and participants when 6’ social 
distancing is not possible (i.e., assessments that requires close observation).
o
Minimize the number of staff who have “hands on” contact with study participants
o
Wearing personnel protective equipment (PPE) including gloves and masks.
o
Washing hands before and after contact with participants

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o
Disinfect surfaces and equipment in the location of the visit before and after each 
participant visit with recommended products from the EPA List N for approved 
disinfectants against SARS-CoV-2.  

Li S et al. Clinical utility of brain stimulation modalities following traumatic brain injury: current 
evidence. Neuropsychiatric Disease and Treatment 2015; 11: 1573-1586.
 
Bikson M et al. Safety of transcranial direct current stimulation: evidence based update 2016. 
 
Richardson J et al. Feasibility of using high-definition transcranial direct current stimulation (HD-
tDCS) to enhance treatment outcomes in persons with aphasia. Neurorehabilitation 2015; 36: 115-
126.
 
Shekhawat GS et al.  Intensity, duration, and location of high-definition transcranial direct current 
stimulation for tinnitus relief. Neurorehabilitation and Neural Repair 2016; 30(4): 349-359.
 
Castillo-Saavedra L et al. Clinically effective treatment of fibromyalgia pain with high-definition 
transcranial direct current stimulation: phase 2 open-label dose optimization. The Journal of Pain 
2016; 17: 14-26.
19.
Potential Benefits to Subjects
There may be a mild temporary improvement in sensory symptoms as a result of participation in this 
study. This study has the potential to increase scientific understanding of the extent to which TBI-
related sensory deficits can be modified with brain stimulation using a longitudinal design. 
Participants will receive a radiology review and report of their MRI scan and will be 
compensated for their time and inconvenience. No other direct benefit to participants is 
anticipated.
20.
Recruitment Methods
The following groups will be recruited via the following methods:
1)
Civilians healthy controls and TBI subjects: by distributed flyers, referrals from clinicians, 
and word of mouth. (overseen by UNM IRB)
2)
Military healthy controls:  by distributed flyers, referrals from clinicians, and word of mouth 
(overseen by NMVAHCS IRB)
3)
Military TBI subjects: Human participants ages 18-69 who are enrolled in the NMVAHCS part 
of the study are automatically invited to come to the UNM CBRR to ask questions prior to 
providing consent. 
Consent forms will be provided, as well as forms that again describe the study procedures and 
potential risks in detail.  If potential participants are unsure about participation, they will be given a 
copy of the consent form with our contact information and be invited to call if they decide to 
participate.  Once informed consent is obtained and the appropriate forms signed, the complete 
procedures of the study, as described in the consent forms, are provided to prospective subjects.  We 
review the forms, and file them away in a locked file cabinet in a locked office at CBRR, away from any 
material with personal or sensitive study data. The participant will be assigned a unique research 
subject identifier (URSI) number, and from that point forward all research data will only be labeled 

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with the URSI number.  
Randomization will occur at time of consenting. Once group membership is determined, individual 
participants will be scheduled for demographic data collection, neuropsychological assessments, 
MRI, MEG at UNM CBRR. Direct identifiers of participants will be maintained on a separate database 
that will be stored behind locked doors, in a locked filing cabinet in a secure area of the UNM CBRR, 
containing only the name, contact information, and address of the participants in order to send 
radiology reports to them, and perform followup telephone calls as needed.
21.
Provisions to Protect the Privacy Interests of Subjects
No personally identifying information will be coded on the questionnaires, neuropsychological 
measures, brain imaging data, or any other data recording instruments, assuring confidentiality to 
the best of our ability. Subject identification numbers are assigned to each participant.  Only the PI 
and HIPAA-trained project coordinator have access to the file that links names with subject numbers.  
Additionally, private health information may also be disclosed to DOD representatives including the 
research monitors and representatives of the DOD are authorized to review research records as a 
part of research oversight.  All data are stored in locked file cabinets in a locked office, and on 
password-protected computers located behind a secure and maintained firewall until the time of 
study completion, or as long as the participant has agreed to have identifying information held for 
the purposes of future studies.
    
All data are collected by the PI, or trained research assistants who have completed on-line training in 
human subjects’ research, HIPAA and research integrity; who are trained in our lab on research data 
management and confidentiality; and who are trained to criteria on project protocol. Data will be 
collected specifically for this proposed research project.
Specially designated interview rooms will be used for the purposes of obtaining consent, conducting 
research, and debriefing subjects.  These rooms will be behind locked facility doors to which only the 
PI and trained research assistants will have access, ensuring privacy of the study participants.   
22.
Economic Burden to Subjects
Responsible Party
Research Procedures
Number 
of 
Samples/Procedur
es
Study
3rd 
Party 
Payer 
or 
Participant
Demographic Assessment
2
x
Neuropsychological/Sensory Testing
2
x
Telephone Interviews
3
x
MEG testing
2
x
MRI
2
x
Intervention
10
x
     
     
     
     
Responsible Party
Standard of Care Procedures
Number 
of 
Samples/Procedur
es
Study
3rd 
Party 
Payer 
or 
Participant
     
     
     
     

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Participants will be responsible for travel to and from the testing site. Participants will not be charged for 
the costs of an investigational drug or device or intervention.  Participants will be responsible for paying 
for treatment of adverse events.  As numerous studies have documented minimal risk of adverse events 
for MRI, MEG, HD-tDCS, and neuropsychological testing with appropriate screening measures, any 
adverse events requiring medical care will be extremely unlikely.  If incidental findings from the study 
result in the need for further evaluation/treatment, the participant or their insurance company will be 
responsible for additional clinical evaluation/treatment that may be needed. Also, incidental finding 
information is disclosed only to the individual participant. However, if a participant chooses to disclose 
such information also to their personal physician, this may become part of their medical record which 
may or may not have an effect in the future on getting health or life insurance. 
23.
 Compensation
Each of the 40 healthy control participants will receive the equivalent of $100 for the first visit 
(Baseline Day 1) and $100 for the second visit (Baseline Day 2).  
Each of the 80 mTBI participants will receive the equivalent of $100 for the first visit (Baseline Day 1), 
$100 for the second visit (Baseline Day 2), $100 for completing the 3rd visit (Post-Stimulation Day 1), 
$100 for completing the 4th visit (Post-Stimulation Day 2), and $60 for completing 3 follow-up visits. 
TBI participants will receive $100 for completing the first 5 intervention visits and $100 for completing 
the second 5 intervention visits. The maximum amount to be paid for involvement in the study is $660. 
Military participants who complete their follow-up visits at the VA will receive compensation for these 
followups via the VA system. This averages out to approximately $20 per hour.  Subjects will be 
reimbursed in the form of merchandise cards dispersed in-person or sent to their email for taking part 
in the study at UNM.  This is felt to be a fair amount that is not coercive and will help decrease attrition 
for this study that involves several visits. If subjects withdraw from the study early, they will be 
compensated for any sessions completed until the time of withdrawal.
Per 24 USC 30, payment to Federal Employees and Active Duty military personnel for participation in 
research while on duty is limited.  Active Duty military personnel may not receive any other payment 
or non-monetary compensation for participation in a research study unless they are off duty or on 
leave during the time they are participating in the protocol.
24.
Compensation for Research-Related Injury
Any medical care required by participants for injuries incurred during the research study will be 
performed at cost to the participant.  All participants will be given information during the consent 
interview and provided at any time during the study regarding how to access urgent and emergency 
care at UNM, including emergency psychiatric care at UNM PES. These facilities are within 5-10 minute 
walk to the MIND Research Network Domenici Hall where the study facilities are located, and may also 
be accessed easily via emergency medical rescue (ie. 911 EMS).  
25.
Consent Process

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Consent will be obtained by the PI, the research coordinator, or a research assistant.  All persons 
obtaining consent will be trained and certified in the ethical treatment of human participants in 
research studies as taught in IRB-required courses.  
In regards to screening for pregnancy, female subjects will be asked if they are pregnant, not 
pregnant, or not sure.  If a woman says she is pregnant, she will be excluded from the study.  All 
women of childbearing age will be required to have a negative pregnancy test to be enrolled. If 
enrolled she will be advised to use two forms of birth control during the time of the stimulation 
phase of the study. If she is not able or willing to take the pregnancy test, she will be excluded from 
the study.  
If a patient remains interested and eligible, the project will be described in great details and the 
potential participant and their caregivers will be invited to ask questions prior to providing consent.  
If the participant is willing, they will be invited to schedule an appointment to undergo informed 
consent prior to study initiation.  Appointments will be held at the Clinical Core in designed interview 
rooms behind secure facility doors so as to ensure privacy. Consent forms will be provided, as well as 
forms that again describe the study procedures and potential risks in detail.  If potential participants 
are unsure about participation, they will be given a copy of the consent form with our contact 
information and be invited to call if they decide to participate.  Once informed consent is obtained and 
the appropriate forms signed, the complete procedures of the study, as described in the consent forms, 
are provided to prospective subjects.  We review the forms, and file them away in a locked file cabinet 
in a locked office, away from any material with personal or sensitive study data.  Participants may 
withdraw their consent at any time during the study.  At each study encounter participants are 
reminded that they have the ability to withdraw consent at any time.  
All subjects will be asked whether they have the ability to consent themselves, or whether 
they have a legally authorized representative (LAR) available to make decisions with regard 
to informed consent for them.  In such cases, patients with a LAR will be excluded from 
participation.
The process of determining whether an individual is capable of consent will take place after the study 
has been explained, but before the subject is asked to sign the consent form.  A short list of questions 
regarding the purpose of the research, the research intervention, the clinical trial structure, the risks 
and benefits of the study, and the voluntary nature of it will be given to the subject before signing the 
consent form, to ensure capacity to understand and comprehend the study.  Each subject must answer 
100% of the “Consent Form Quiz” questions correctly; if answers are ambiguous or unclear the 
research team member will prompt the subject to clarify their meaning.  If any questions are not 
answered correctly, the research team member will remind the subject of the pertinent information, 
and then ask the question(s) again.  This will be repeated up to 2 times.  If the subject still fails to 
answer the questions 100% appropriately after the third attempt, they may be invited back to undergo 
the consent process again on a different day.  If after a second consent process the subject still cannot 
answer the questions 100% correctly, that subject will be excluded from the study.
If public health conditions require in-person research encounters be minimized some of the outlined 
consent procedures may be conducted over the phone.  The following outlines phone consent 
procedures:
Military and healthy control participants (ages 18-69) enrolled in the study protocol at the NMVAHCS 
will automatically be called so that they can ask questions prior to providing consent (for UNM part of 
protocol).  After discussing the study and asking questions, potential participants who complete 
screening and are eligible for participation, will be mailed or emailed the consent form that describes 
the study procedures and potential risks in great detail.  Participants will be given our contact 
information and be invited to call if they decide to participate.  If they decide to participate, a consent 
phone call will be conducted in which the consent form is reviewed, the participant can ask questions, 

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and if interested in continuing participation, the Consent Form Quiz will be completed (over the 
phone).  If they are successful with the quiz, they will be scheduled for their first visit.  
Consent form signature will be done in person, at their first visit, so that it can be witnessed and signed 
by research staff.  Once informed consent is obtained and the appropriate forms signed, the participant 
will be assigned a unique research subject identifier (URSI) number, and from that point forward all 
research data will only be labeled with the URSI number.  The key linking identifiers of participants to 
the URSI will be maintained on a separate database that will be stored behind locked doors, in a locked 
filing cabinet in a secure area of the CBRR, and on the UNMHSC secure server.
The participants will be reminded at each study encounter that they have the ability to withdraw 
consent at any time to protect against loss of capacity to consent. It is highly unlikely that there will be 
any deterioration in decisional capacity as a result of the study procedures themselves, as they exert 
no direct effect on the brain. Given that subjects will only have mild TBIs, with chronic symptoms, it is 
also unlikely that they will lose decisional capacity spontaneously during the course of the study.  
However, should study staff or the PI suspect a change in capacity due to new inability to follow the 
protocol, the subject will be assessed, and undergo re-consent if appropriate.
26.
Documentation of Consent (see attached forms)
27.
Study Test Results/Incidental Findings (see next section)
28.
Sharing Study Progress or Results with Subjects
As the neuropsychological and MEG tests employed in the study are for research purposes and not 
diagnostic purposes, these results will not be shared with the participants, unless their physician 
requests to see a report. In this instance the Clinical Core will obtain the participant’s permission to 
generate a summary report of the neuropsychological test results and send this to the participant’s 
primary care physician. Subjects will not be provided with summaries of trial progress, or summaries 
of study results.
All research MRI scans are read for incidental findings by a radiologist. A report is sent by mail to the 
participant.  When the scan is read, an e-mail notification is sent to the participant letting them know 
new results are available. The participant can securely log in to the COINS Homepage to access their 
MRI radiology report. No sensitive or identifying information is sent via e-mail. If an abnormality that 
requires follow-up is identified, such as a Doctor Referral recommendation, a hard copy of the report 
may be mailed to the participant in addition to the e-mail notification. In these cases, the MRN Medical 
Director may also attempt to contact the participant by phone to explain the information and help 
answer questions.
29.
Inclusion of Vulnerable Populations
There will be no gender restrictions with regard to sample inclusion.  It is expected that our sample 
will reflect a mix of national sample characteristics of military TBI populations (approximately 95% 
male and 5% female) and civilian TBI populations (approximately 55% male and 45% female). The 
age range of 18-69 years was selected because we did not want to include developmental processes in 
our analyses and by 18 years old, many major neurodevelopmental changes in the brain will have 
taken place.  Using similar logic, we chose to include participants up to the age of 69 because we do not 
want to include advancing age-related changes in our analyses.  It is expected that the sample included 
in this study will reflect the demographics of the greater Albuquerque metropolitan community. The 
racial composition of the community is 69.7% White, 2.47% African American, 5.53% Native American, 
1.64% Asian, 0.10% Pacific Islander, 16.37% from other races, and 4.15% from two or more races.  
Hispanic or Latino people of any race were 41.48% of the population.  Through randomization, we will 
ensure that the sample obtained represents the study population.  Adults unable to consent, 

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individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners will 
be excluded from the study.
The compensation for participation in the study is calibrated so as not to exert undue influence on 
economically disadvantaged participants.  The materials, instructions, consents, and scripts involved 
in the study will be geared toward a low-enough educational level that the majority of educationally 
disadvantaged participants will be able to understand them.
    
Recruitment will be unrestricted with regard to minorities, with the exception that non-English 
reading/speaking-only individuals will not be eligible.  Albuquerque’s population is multicultural, with 
a particularly large representation of Hispanic (mostly Mexican American) people.  Ethnicity, Hispanic 
or other, will be determined through self-identification.  In compliance with NIH policy participants 
will be asked to self identify as to Hispanic or Non-Hispanic as well as American Indian or Alaska 
Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White.  All 
possible combinations of the multiple responses will be reported.
30.
Community-Based Participatory Research N/A
31.
Research Involving American Indian/Native Populations N/A
32.
Transnational Research N/A
33.
Drugs or Devices
During testing sessions, subjects will be engaging in sensory tasks. One of the tasks will be delivered 
using a commercially available head-mounted virtual reality device, Oculus Rift DK. This device will be 
outfiitted with eye-tracking sensors to quantify subject’s eye movements in response to the vision 
therapy, so as to assess symptom reduction (iscan.com). Because these devices simply display images 
and record eye movements, without imparting any energy into the head or body, they are 
nonsignificant risk. The only potential side effect of use of the Oculus Rift is mild nausea.
During intervention sessions, subjects will receive HD-tDCS while performing sensory training tasks 
on a computer. 
The HD-tDCS device is determined to be a Non-Significant Risk device by the sponsor-investigator 
(Davin Quinn, MD) for the following reasons:
1)  It is not intended as an implant.  
2)  It does not present a potential for serious risk to the health, safety, or welfare of the subjects. 
3)  It is not proposed to be for use in supporting or sustaining human life.  
4)  It is not of substantial importance in diagnosing, curing, mitigating, or treating  disease, or 
preventing impairment of human health.  
According to the FDA, serious adverse events are those in which the outcome is death, life-threatening, 
hospitalization, disability/permanent damage, congenital anomaly, requiring intervention to prevent 
permanent impairment, or other serious events such as refractory seizures, cardiorespiratory arrest, 
or anaphylactic reaction.  No serious adverse events attributable to HD-tDCS have been reported in the 
more than 10,000 subjects investigated in the contemporary tDCS literature since 1998.  This literature 
includes studies in patients with severe brain injury, stroke, epilepsy, and neurodegenerative 
disorders, none of whom have been reported to experience serious adverse events.  Specifically, there 
have been no reports or evidence presented of damage to the brain, seizures, or cardiorespiratory 
arrest.  Animal studies of charge densities necessary to induce brain damage in rats were found to be 
100 times higher than the charge density used in TDCS trials with standard parameters (< 2.5 mA, no 

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more than 2 sessions daily, < 60 min per session, use of electrodes that minimize skin burns) as 
determined by world-wide expert consensus. As this trial will be operating within standard 
parameters as defined above, we believe our use of HD-tDCS in subjects with mild traumatic brain 
injury represents a Non-Significant Risk. Even more reassuring, tDCS at 1.0-2.0 mA has been 
performed over damaged left frontal cortex in 37 patients with moderate to severe TBIs, who are at 
the highest risk of post-traumatic seizures and demonstrate the greatest levels of structural damage, 
without adverse events, seizures, or decrements in neurologic status.(Li et al, 2016) A review of and 
contact with studies registered in clinicaltrials.gov for tDCS in TBI (Spaulding, NYU, U. Leige) did not 
discover any occurrence of seizures or adverse events. 
Furthermore, the Soterix MxN device has already been deemed a Non-Significant Risk device by the 
UNM HSC HRRC in several studies, one involving neurologically damaged patients (Study #16-091, 
“Targeted transcranial direct current stimulation (tDCS) to Enhance Speech-Language Treatment 
Outcomes in Persons with Chronic Post Stroke Aphasia; Study #16-328, “Real-time measurement of 
cortical hemodynamics during concurrent brain stimulation  and cognitive tasks. 
Given that our patient population is an outpatient, ambulatory, mild TBI population and that these 
current strengths and amounts have already been administered safely to patients with stroke lesions 
ipsilateral and proximal to the site of stimulation, we feel that HD-tDCS is extremely safe.  Our group is 
currently studying HD-tDCS in subjects with stroke and healthy controls and are have found the 
stimulation to be very safe and well tolerated. There are no long-term neuropsychiatric effects from 
HD-tDCS.  With repeated stimulation, some subjects get dry skin.  Applying lotion helps to ameliorate 
this.  Using EEG gel for the electrode conductor helps reduce this occurrence as well. The commonly 
reported side effects of HD-tDCS are itching, burning, tingling, headache, and discomfort (10-40%), all 
of which are mild and transient.  A few people in other studies have experienced drowsiness, 
excitement, or dizziness after HD-tDCS.
As with any contact between persons and electrical apparatuses, there is a slight possibility of 
electrical shock. To our knowledge, no studies have reported any electrical shock resulting from HD-
tDCS, and we do not expect this event to occur in our experiment.

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34.
Checklist Section
This section contains checklists to provide information on a variety of topics that require 
special determinations by the IRB.  Please complete all checklists relevant to your research.
I.
Waivers or Alterations of Consent, Assent, and HIPAA Authorization
A. Partial Waiver of Consent for Screening/Recruitment
Complete this checklist if you are requesting a partial waiver of consent so that you 
can review private information to identify potential subjects and/or determine 
eligibility prior to approaching potential subjects for consent or parental 
permission.
1. Describe the data source that you need to review (e.g., medical records):
2. Describe the purpose for the review (e.g., screening):
3. Describe who will conducting the reviews (e.g., investigators, research 
staff):
4. Do all persons who will be conducting the reviews already have permitted 
access to the data source?
 Yes
 No. Explain:      
5. Verify that each of the following are true or provide an alternate 
justification for the underlined regulatory criteria:
a) The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of 
the records review will not be used for any purposes other than 
those described above.
 True
 Other justification:      
b) The waiver or alteration will not adversely affect the rights and 
welfare of the subjects because eligible subjects will be approached 
for consent to participate in the research and are free to decline.  
Further, the information accessed during the records review will 
not be disclosed to anyone without a legitimate purpose (e.g., 
verification of eligibility).
 True
 Other justification:      

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c) The research could not practicably be carried out without the 
waiver or alteration because there is no other reasonably efficient 
and effective way to identify who to approach for possible 
participation in the research.  
 True
 Other justification:      
d) Whenever appropriate, potentially eligible subjects will be 
presented with information about the research and asked to 
consider participation.  (Regulatory criteria: Whenever appropriate, 
the subjects will be provided with additional pertinent information 
after participation.)
 True
 Other justification:      
Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will 
review to identify potential subjects and/or determine eligibility include Protected 
Health Information (PHI).
6. Will you be recording any PHI when conducting the records review to 
identify potential subjects and/or determine eligibility?
 Yes. Describe:      
 No
7. If you answered “Yes” to question 6 above, please describe when you will 
destroy identifiers (must be the earliest opportunity consistent with the 
conduct of the research) or provide justification for why they must be 
retained:
     
8. The PHI accessed or recorded for identification/screening purposes will 
not be reused or disclosed to (shared with) any other person or entity, 
except as required by law, for authorized oversight of the research study, 
or for other research for which the use or disclosure of the PHI would be 
permitted under the Privacy Rule.
 True
 False
B. Waiver of Documentation of Consent
Complete this checklist if you intend to obtain consent verbally but will not be 
obtaining signatures from subjects on a consent form to document consent.  Waivers 

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of documentation of consent are commonly requested when using scripts, 
information sheets, or email or survey introductions to present the elements of 
consent instead of using a traditional consent form.
1. Are you requesting a waiver of documentation of consent for some or all 
subjects?
 All
 Some. Explain:      
2. Provide justification for one of the following:
a) That the only record linking the subject and the research would be 
the consent document and the principal risk would be potential 
harm resulting from a breach of confidentiality. Each subject will be 
asked whether the subject wants documentation linking the subject 
with the research, and the subject's wishes will govern.
     
b) That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context.
     
3. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form?
 Yes. Please attach a copy to your submission in Click.
 No
C. Alteration of Consent
Complete this checklist if you intend to obtain consent but will be eliminating or 
altering one or more of the required elements of consent. Alterations of consent are 
commonly requested for research involving deception or for minimal risk research 
when an abbreviated consent is desired and one or more of the required element are 
not relevant to the research.
Note: FDA-regulated research is not eligible for an alteration of consent.
1. Which element(s) of consent do you wish to eliminate and why?
     
2. Which element(s) of consent do you wish to alter and why?
     

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3. Provide justification for each of the following regulatory criteria:
a) The research involves no more than minimal risk to the subjects:
     
b) The waiver or alteration will not adversely affect the rights and 
welfare of the subjects:
     
c) The research could not practicably be carried out without the 
waiver or alteration:
     
d) Whenever appropriate, the subjects will be provided with 
additional pertinent information after participation:
     
D. Full Waiver of Consent/Parental Permission
Complete this checklist if you are requesting a full waiver of consent for all subjects 
or certain subject groups (e.g., retrospective cohort).  Full waivers of consent are 
commonly requested when the research does not include any opportunity for 
interaction with subjects (e.g., chart review).
Note: FDA-regulated research is not eligible for a full waiver of consent using 
these criteria.  If you believe that your FDA-regulated research may be eligible for 
a waiver under another mechanism, such as planned emergency research, contact 
the HRPO for assistance in determining what information to provide to the HRRC.
1. Are you requesting a waiver for some or all subjects?
 All
 Some. Explain:      
2. Provide justification for each of the following regulatory criteria:
a) The research involves no more than minimal risk to the subjects:
     
b) The waiver or alteration will not adversely affect the rights and 
welfare of the subjects:
     
c) The research could not practicably be carried out without the 
waiver or alteration:
     

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d) Whenever appropriate, the subjects will be provided with 
additional pertinent information after participation:
     
E. Full Waiver of Consent/Parental Permission (Public Benefit or Service 
Programs)
Complete this checklist if you are requesting a full waiver of consent for all subjects 
or certain subject groups (e.g., retrospective cohort) and the research involves the 
evaluation of a public benefit or service program.  
1. Are you requesting a waiver for some or all subjects?
 All
 Some. Explain:      
2. Provide justification for each of the following regulatory criteria:
a) The research or demonstration project is to be conducted by or 
subject to the approval of state or local government officials and is 
designed to study, evaluate, or otherwise examine: (i) public benefit 
or service programs; (ii) procedures for obtaining benefits or 
services under those programs; (iii) possible changes in or 
alternatives to those programs or procedures; or (iv) possible 
changes in methods or levels of payment for benefits or services 
under those programs:
     
b) The research could not practicably be carried out without the 
waiver or alteration.
     
F. Full Waiver of HIPAA Authorization
Complete this checklist if you are requesting a full waiver of the requirement to 
obtain HIPAA authorization for all subjects or certain subject groups (e.g., 
retrospective cohort).  Full waivers of HIPAA authorization are commonly requested 
when the research does not include any opportunity for interaction with subjects 
(e.g., chart review).
1. Are you requesting a waiver of authorization for some or all subjects?
 All
 Some. Explain:      
2. Describe your plan to protect health information identifiers from improper 
use and disclosure:

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3. Describe your plan to destroy identifiers at the earliest opportunity 
consistent with conduct of the research (absent a health or research 
justification for retaining them or a legal requirement to do so):
     
4. Describe why the research could not practicably be conducted without the 
waiver or alteration:
     
5. The PHI accessed or recorded for identification/screening purposes will 
not be reused or disclosed to (shared with) any other person or entity, 
except as required by law, for authorized oversight of the research study, 
or for other research for which the use or disclosure of the PHI would be 
permitted under the Privacy Rule.
 True
 False
G. Other Waiver Types
If you are seeking another waiver type (e.g., Planned Emergency Research, Waiver 
of Parental Permission to Protect Child Participants, Enforcement Discretion for In 
Vitro Diagnostics, etc. contact the HRPO office for assistance in determining what 
information to submit for the HRRC’s consideration.
II. Vulnerable Populations
A. Adults with Cognitive Impairments
Complete this checklist if the subject population will include adults with cognitive 
impairments.  
This checklist does not need to be completed if the research doesn’t involve 
interactions or interventions with subjects and will be conducted under a waiver of 
consent.
1. Describe why the objectives of the study cannot be met without inclusion 
of adults with cognitive impairments.
Traumatic brain injury results in a set of well-known postconcussive symptoms, that include 
difficulties with memory and attention. Therefore, in order to study a treatment for 
postconcussive symptoms, a population of subjects with TBI must be enrolled, and these subjects 
may have cognitive impairments.

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2. Describe how capacity to consent will be evaluated.
A consent quiz covering key aspects of the study will be administered after explanation of the 
consent form, but before signing.  Participants must answer all questions on the quiz correctly 
in order to be permitted to enroll in the study. They will receive two opportunities to correct 
any incorrect answers. If after two opportunities the subject still cannot answer the question 
correctly, the subject will not be enrolled.
3. If subjects may regain capacity to consent, or if subjects may have 
fluctuating capacity to consent, describe your plans to evaluate capacity to 
consent throughout the research and to obtain consent to continue 
participation if capacity is regained.
All subjects will be re-evaluated for capacity to consent by study staff if there is reason to 
suspect a loss of capacity, such as new inability to perform the study tasks. If capacity to re-
consent is not present, the subject will be dropped from the study, and all necessary measures 
taken to refer the subject to appropriate medical care, such as referral to a physician, or 
transport to an emergency department.  However, given that all subjects will have only mild 
traumatic brain injuries, that are chronic in nature, it is highly unlikely that a subject will lose 
capacity to consent during the course of the study.
4. Describe your plans, if any, to provide information about the research to 
subjects and the steps you will take to assess understanding.
Subjects will be provided with the consent, and the protocol, if requested, to read before 
undergoing informed consent. Capacity to provide informed consent will be assessed for every 
patient entering the study. This includes a quiz that assess understanding of the nature of the 
project, its status as research, and the voluntary nature of the subject’s participation.
5. Describe your plans to obtain assent, including whether assent will be 
obtained from none, some, or all subjects.
As subjects must be able to give their own informed consent to be in the study, and no subjects 
with legally appointed guardians will be allowed to enter the study, assent will not be obtained.
6. Describe why risks to subjects are reasonable in relation to anticipated 
benefits to the subjects.
There are only nonsignificant risks associated with the procedures of this study, which include 
neuropsychological testing, demographic assessment, and brain imaging. Therefore the risk to 

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subjects is miniscule and is not disproportionate to the minimal benefit anticipated for subjects 
in this study (having a brain scan performed).
7. If this study involves a health or behavioral intervention, describe why the 
relation of the anticipated benefit to the risk of the research is at least as 
favorable to the subjects as that presented by alternative procedures.
In this protocol at UNM there is no health or behavioral intervention.
8. Describe your plans for monitoring the well-being of subjects including 
any plans to withdraw subjects from the research if they appear to be 
unduly distressed.
At every study visit subjects will be asked if they are still willing to be in the study. Every study 
visit involves collection of data that pertains to their mental state, and thus study staff will be 
well aware if any subject is unduly distressed. In these circumstances, if a subject is unduly 
distressed, they will be offered the opportunity to stop the study procedures, or to speak to a 
study staff member, or to drop out of the study entirely.  If in need of referral or immediate 
medical assistance, the study staff will ensure the subject receives the appropriate level of care 
for their distress.
B. Children
Complete this checklist if the subject population will include children.
1. Select the category of research that you believe this research falls within 
and provide justification for any associated criteria.  If there are different 
assessments for different groups of children or arms (e.g., placebo vs. 
drug), include a memo to provide an assessment for each group.  
 Research not involving greater than minimal risk. (Minimal risk 
means that the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than 
those ordinarily encountered in daily life or during the performance 
of routine physical or psychological examinations or tests.)
 Research involving greater than minimal risk but presenting the 
prospect of direct benefit to the individual subjects.
Provide justification for each of the following criteria:
(1) The risk is justified by the anticipated benefit to the subjects:
     

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(2) The relation of the anticipated benefit to the risk is at least 
as favorable to the subjects as that presented by available 
alternative approaches:
     
 Research involving greater than minimal risk and no prospect of 
direct benefit to individual subjects, but likely to yield generalizable 
knowledge about the subject's disorder or condition.
Provide justification for each of the following criteria:
(1) The risk represents a minor increase over minimal risk:
     
(2) The intervention or procedure presents experiences to 
subjects that are reasonably commensurate with those 
inherent in their actual or expected medical, dental, 
psychological, social, or educational situations:
     
(3) The intervention or procedure is likely to yield generalizable 
knowledge about the subjects' disorder or condition which 
is of vital importance for the understanding or amelioration 
of the subjects' disorder or condition
     
C. Pregnant Women and Fetuses
Complete this checklist if the subject population will include pregnant women and 
fetuses.
This checklist does not need to be completed if the research is both minimal risk and 
is not conducted, funded, or otherwise subject to regulation by DHHS, DOD, EPA, or 
VA.
Provide justification for each of the following:
1. Where scientifically appropriate, preclinical studies, including studies on 
pregnant animals, and clinical studies, including studies on non-pregnant 
women, have been conducted and provide data for assessing potential risks 
to pregnant women and fetuses.
     
2. The risk to the fetus is caused solely by interventions or procedures that 
hold out the prospect of direct benefit for the woman or the fetus; or, if 
there is no such prospect of benefit, the risk to the fetus is not greater than 

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minimal and the purpose of the research is the development of important 
biomedical knowledge which cannot be obtained by any other means.
     
3. Any risk is the least possible for achieving the objectives of the research.
     
D. Neonates of Uncertain Viability or Nonviable Neonates
Complete this checklist if the subject population will include neonates of uncertain 
viability.
Provide justification for each of the following:
1. Where scientifically appropriate, preclinical and clinical studies have been 
conducted and provide data for assessing potential risks to neonates.
     
2. Each individual providing consent is fully informed regarding the 
reasonably foreseeable impact of the research on the neonate.
     
3. Individuals engaged in the research will have no part in determining the 
viability of a neonate.
     
4. The research holds out the prospect of enhancing the probability of 
survival of the neonate to the point of viability, and any risk is the least 
possible for achieving that objective, or, the purpose of the research is the 
development of important biomedical knowledge which cannot be 
obtained by other means and there will be no added risk to the neonate 
resulting from the research
     
E. Nonviable Neonates
Complete this checklist if the subject population will include nonviable neonates.
Provide justification for each of the following:
1. Where scientifically appropriate, preclinical and clinical studies have been 
conducted and provide data for assessing potential risks to neonates.
     

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2. Each individual providing consent is fully informed regarding the 
reasonably foreseeable impact of the research on the neonate.
     
3. Individuals engaged in the research will have no part in determining the 
viability of a neonate.
     
4. The purpose of the research is the development of important biomedical 
knowledge that cannot be obtained by other means.
     
Verify each of the following:
5. Vital functions of the neonate will not be artificially maintained
 True
 False
6. The research will not terminate the heartbeat or respiration of the neonate
 True
 False
7. There will be no added risk to the neonate resulting from the research
 True
 False
F. Biomedical and Behavioral Research Involving Prisoners
Complete this checklist if the subject population will include prisoners.
Note: Minimal risk for research involving prisoners is the probability and magnitude 
of physical or psychological harm that is normally encountered in the daily lives, or 
in the routine medical, dental, or psychological examination of healthy persons.
1. Select and justify which allowable category of research involving prisoners 
this research falls within:
 Study of the possible causes, effects, and processes of incarceration, and 
of criminal behavior, provided that the study presents no more than 
minimal risk and no more than inconvenience to the subjects
     

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 Study of prisons as institutional structures or of prisoners as 
incarcerated persons, provided that the study presents no more than 
minimal risk and no more than inconvenience to the subjects
     
 Research on conditions particularly affecting prisoners as a class (for 
example, vaccine trials and other research on hepatitis which is much 
more prevalent in prisons than elsewhere; and research on social and 
psychological problems such as alcoholism, drug addiction, and sexual 
assaults)
     
 Research on practices, both innovative and accepted, which have the 
intent and reasonable probability of improving the health or well-being 
of the subject
     
 Epidemiologic studies in which the sole purpose is to describe the 
prevalence or incidence of a disease by identifying all cases or to study 
potential risk factor associations for a disease, the research presents no 
more than Minimal Risk and no more than inconvenience to the 
subjects, and Prisoners are not a particular focus of the research.
     
2. Provide justification for each of the following regulatory criteria:
a) Any possible advantages accruing to the prisoner through his or her 
participation in the research, when compared to the general living 
conditions, medical care, quality of food, amenities and opportunity 
for earnings in the prison, are not of such a magnitude that his or 
her ability to weigh the risks of the research against the value of 
such advantages in the limited choice environment of the prison is 
impaired
     
b) The risks involved in the research are commensurate with risks that 
would be accepted by nonprisoner volunteers
     
c) Procedures for the selection of subjects within the prison are fair to 
all prisoners and immune from arbitrary intervention by prison 
authorities or prisoners. Unless justification is provided, control 
subjects must be selected randomly from the group of available 

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prisoners who meet the characteristics needed for that particular 
research project
     
d) The information is presented in language which is understandable 
to the subject population
     
e) Adequate assurance exists that parole boards will not take into 
account a prisoner's participation in the research in making 
decisions regarding parole, and each prisoner is clearly informed in 
advance that participation in the research will have no effect on his 
or her parole
     
f)
When appropriate, adequate provision has been made for follow up 
examination or care after research participation, taking into 
account the varying lengths of individual prisoners' sentences, and 
for informing participants of this fact
     
III. Medical Devices
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  
If more than one medical device is being evaluated, provide the requested information for each.
A. Device Name: MxN multichannel transcranial electrical stimulator
B. Manufacturer:  Soterix Medical, Inc.
C. Does the research involve a Significant Risk Device under an IDE?
 Yes. Include documentation of the FDA approval of the IDE with your submission.  
Acceptable methods of documentation include: (1) FDA letter noting IDE number 
and approval status; (2) Industry sponsor letter noting IDE number and FDA 
approval status; or (3) FDA-approved industry sponsor protocol with IDE number 
noted 
 No
D. Is the research IDE-exempt?
 Yes. Include a FDA letter with your submission noting the determination that the 
research is IDE-exempt or a letter from the sponsor (or sponsor-investigator) 
justifying why they believe the research is IDE-exempt*.  

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 No
E. Does the research involve a Non-Significant Risk (NSR) Device?
 Yes. Include a FDA letter with your submission noting the determination that the 
research is NSR or a letter from the sponsor (or sponsor-investigator) justifying 
why they believe the research is NSR**.  
 No
* This FDA guidance includes a description for when a device study is exempt from 
the 
IDE 
requirements: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.p
df 
**This FDA guidance includes information on how to differentiate between 
Significant 
Risk 
and 
Non-Significant 
Risk 
device 
studies: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.p
df 
Appendix A
DSMB Personnel and Duties
Christopher Abbott, MD
Associate Professor: Psychiatry Geriatrics
CAbbott@salud.unm.edu
(505)-272-2223
Sarah Pirio Richardson, MD
Associate Professor: Neurology Adult
SPirioRichardson@salud.unm.edu
(505)-272-3342
Summary of Duties: Will participate in quarterly DSMB meetings to act in an advisory capacity 
to the study team to monitor participant safety and data quality and evaluate the progress of the 
study.  They will serve in an individual capacity and provide expertise and recommendations.  
As a part of the DSMB, they will be responsible for safeguarding the interests of trial participants, 
for assessing the safety of the interventions during the trial, and for monitoring the overall conduct 
of the clinical trial. They will provide recommendations about stopping or continuing the trial and 
may also formulate recommendations relating to the selection/recruitment/retention of 
participants, their management, adherence to protocol specified-regimens, and procedures for data 
management and quality control.  As members of this DSMB, they will have a further 
responsibility to consider the interests of research subjects whose therapy may ultimately be 
influenced by trial results.  

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Authorities: Shall have authority to stop a research protocol in progress, remove individual 
human subjects from a research protocol, and take whatever steps are necessary to protect the 
safety and well-being of human subjects until the IRB can assess the monitor's report.
Responsibilities: Shall have the responsibility to promptly report their observations and findings 
to the IRB or other designated official and the HRPO.
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1. 
Fausti SA, Wilmington DJ, Gallun FJ, Myers PJ, Henry JA. Auditory and vestibular dysfunction 
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doi:10.1682/JRRD.2008.09.0118.
2. 
Alvarez TL, Kim EH, Vicci VR, Dhar SK, Biswal BB, Barrett AM. Concurrent vision dysfunctions in 
convergence insufficiency with traumatic brain injury. Optom Vis Sci. 2012;89(12):1740-1751.
3. 
Saunders GH, Echt K V. Blast exposure and dual sensory impairment: an evidence review and 
integrated rehabilitation approach. J Rehabil Res Dev. 2012;49(7):1043-1058.
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Pogoda TK, Hendricks AM, Iverson KM, et al. Multisensory impairment reported by veterans with and 
without mild traumatic brain injury history. J Rehabil Res Dev. 2012;49(7):971-984.
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Mesulam M. From sensation to cognition. Brain. 1998;121:1013-1052.
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Mayer AR, Hanlon FM, Dodd AB, Ling JM, Klimaj SD, Meier TB. A functional magnetic resonance 
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Larson MJ, Perlstein WM, Demery J a, Stigge-Kaufman D a. Cognitive control impairments in traumatic 
brain injury. J Clin Exp Neuropsychol. 2006;28(6):968-986. doi:10.1080/13803390600646860.
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Hunter MA, Houck J, Quinn DK, et al. Investigating auditory attention in mild traumatic brain injury 
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June 29, 2016. ; 2016.
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Diwakar M, Harrington DL, Maruta J, et al. Filling in the gaps : Anticipatory control of eye movements 
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Stephen JM, Coffman BA, Stone DB, Kodituwakku P, Bompas A, Neuroscience L. Differences in MEG 
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Hum Neurosci. 2013;7(December):1-9. doi:10.3389/fnhum.2013.00900.
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Alvarez TL, Jaswal R, Gohel S, Biswal BB. Functional activity within the frontal eye fields , posterior 
parietal cortex , and cerebellar vermis significantly correlates to symmetrical vergence peak velocity : 
an ROI-based , fMRI study of vergence training. Front Integr Neurosci. 2014;8(June):1-12. 
doi:10.3389/fnint.2014.00050.
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Lewine JD, Davis JT, Sloan JH, Kodituwakku PW, Orrison WW. Neuromagnetic assessment of 
pathophysiologic brain activity induced by minor head trauma. AJNR Am J Neuroradiol. 

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1999;20(May):857-866.
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Hoffer ME, Balaban CD. Early Diagnosis and Tre a t m e n t o f Tr a u m a t i c Ves t i b u l o p a t h y a n d 
Postconcussive Dizziness. Neurol Clin NA. 2015;33(3):661-668. doi:10.1016/j.ncl.2015.04.004.
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Hunter M a, Coffman B a, Trumbo MC, Clark VP. Tracking the neuroplastic changes associated with 
transcranial direct current stimulation: a push for multimodal imaging. Front Hum Neurosci. 
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Hunter M a, Coffman B a, Gasparovic C, Calhoun VD, Trumbo MC, Clark VP. Baseline effects of 
transcranial direct current stimulation on glutamatergic neurotransmission and large-scale network 
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Richardson J, Datta A, Dmochowski J, Parra LC, Fridriksson J. Feasibility of using high-definition 
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Bikson M, Rahman A, Datta A. Computational models of transcranial direct current stimulation. Clin 
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Hsu W, Ku Y, Zanto TP, Gazzaley A. Neurobiology of Aging Effects of noninvasive brain stimulation on 
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