Clinical trial NCT04022226
Conditions: Electroconvulsive Therapy Direct Current Electroencephalogram Ketamine Spreadind Depression
Sponsor: University of New Mexico
Start date: 2019-10-01; Completion date: 2020-10-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.

Detailed description:
This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.

Arms: arm 1: Standard of care anesthesia that does not affect slow wave characteristics arm 2: Standard of care anesthesia that suppresses slow wave characteristics
Interventions: intervention 1: Ketamine intervention 2: Methohexital
Intervention descriptions: intervention 1: Induction agent that suppresses infra-slow waves intervention 2: Induction agent that does not suppress infra-slow waves

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL TITLE:
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A Randomized Pilot Study Examining DCEEG 
Characteristics in Ketamine versus Methohexital 
Induction in Depressed Patients Receiving 
Electroconvulsive Therapy


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PROTOCOL TITLE:
A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine 
versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive 
Therapy
PRINCIPAL INVESTIGATOR:
Jeremy Miller, MD
Department of Psychiatry
University of New Mexico
ADMINISTRATIVE CONTACT:
Department of Psychiatry
VERSION NUMBER:
UNM IRM version 1.10
DATE:
December 5th, 2019
REGULATORY FRAMEWORK:
Please indicate all that apply:
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 per the NIH definition of a Clinical Trial?   
 Yes   
 No
NIH Definition of a Clinical Trial: 
A research study in which one or more human subjects are prospectively 
assigned to one or more interventions. An "intervention" is defined as a 
manipulation of the subject or subject’s environment for the purpose of modifying 
one or more health-related biomedical or behavioral processes and/or endpoints. 
Examples include: drugs/small molecules/compounds; biologics; devices; 
procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-
to-face interviews); strategies to change health-related behavior (e.g., diet, 
cognitive therapy, exercise, development of new habits); treatment strategies; 
prevention strategies; and, diagnostic strategies. (which may include placebo or 
other control) to evaluate the effects of those interventions on  health-related 
biomedical or behavioral outcomes.    
If yes, please confirm that the research team is familiar with and agrees to 
comply with the investigator requirement to register the study on the 


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ClinicalTrials.gov database. Additionally, the approved consent document(s) 
must be uploaded to the ClinicalTrials.gov database
 Yes   
 No 
FUNDING:
CTSC Pilot Project: CTSC funding pending


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


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1.
Objectives
Electroconvulsive therapy (ECT) is an effective treatment for depression, mania, and 
psychosis, and has been around for over 80 years. An initial series of ECT consists 
of 8-12 treatments. At each treatment, electrical current passes through the brain 
and induces a seizure. The reason for ECT’s high efficacy in a heterogeneous set of 
mental illnesses remains unknown. Without a biomarker of treatment adequacy, the 
titration schedule for dosing was empirically derived and a trial and error approach 
dictates treatment.
The electroencephalogram (EEG) is used to monitor seizure activity during ECT. 
EEG measures have been evaluated as markers for treatment adequacy, but were 
found to be ineffective, mainly due to EEG’s inability to discriminate between 
dosages in unilateral electrode placement and the weak association between EEG 
characteristics and clinical outcome [1]. Our neuromodulation group has recently 
deployed direct current EEG (dcEEG) in patients undergoing ECT. DcEEG differs 
from normal EEG by its ability to measure slow cortical potentials (SCPs) in low 
frequencies. SCPs are shifts in the cortical electrical activity lasting from several 
hundred milliseconds to several seconds. These SCPs may offer insight into 
inhibitory processes heretofore unexplored. We have captured large infra-slow brain 
activity using dcEEG on patients receiving ECT. This activity is consistent with a type 
of SCP called cortical spreading depression (SD). These so-called “brain tsunamis” 
are powerful, propagating waves of near-complete depolarization resulting in 
suppression of neuronal activity and are associated with the pathophysiology of 
stroke, traumatic brain injury, epilepsy, and migraines [2]. However, studies in rats 
and mice have associated SD in healthy brain tissue with neurogenesis [3, 4]. One 
in-vivo study with rats found that SD happened during ECT and suggested SD-
induced neurogenesis as the neurobiological element underpinning ECT’s clinical 
effectiveness [5]. We can observe the role SDs play in ECT based on the anesthesia 
used. 
Ketamine is an induction agent often used in ECT. Ketamine reduces seizure 
threshold and was thought to produce superior results given the longer and more 
pronounced seizures seen in ECT. However, multiple randomized controlled trials 
(RCTs) have shown no difference in clinical efficacy between ketamine and other 
induction agents [6]. Unlike other induction agents, ketamine blocks SDs [7]. This 
may explain why ketamine has not delivered on its promise. While it accentuates 
seizure production and strength, it may block SD-induced neurogenesis. 
Methohexital is another induction agent used in ECT. Although methohexital 
decreases seizure length and raises seizure threshold in comparison to ketamine, 
there is no difference in clinical outcome between methohexital and ketamine when 
used with ECT [8, 9].
Our long-term goal is to develop a biomarker of treatment in patients receiving ECT. 
By having this biomarker, practitioners could move towards individualized treatment 
parameters. We hypothesize that ictal power and post-ictal infra-slow waves will be 
associated with clinical response and the choice of anesthetic agent will accentuate 
ictal or post-ictal morphology. We propose a pilot project using dcEEG to look at 
infra-slow waves in depressed patients receiving ECT randomized to ketamine or 
methohexital. The rationale for this project is to identify biomarkers of treatment 
adequacy in ECT, which could lead to decreased morbidity and mortality with the 
procedure and lessen the burden of depression in our patient population. 
Aim 1: Identify EEG biomarkers related to clinical response


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Hypothesis 1.1: Ketamine will be associated with increased ictal power and 
increased post-ictal suppression compared to methohexital
Hypothesis 1.2: Methohexital will be associated with post-ictal infra-slow waves
Hypothesis 1.3: Increased ictal power and infra-slow waves will be associated 
with clinical outcomes
At the completion of this pilot project, we expect to identify infra-slow characteristics 
using dcEEG that correspond with clinically effective treatment. We plan to further 
evaluate these phenomena as a potential biomarker of treatment adequacy with the 
goal of individualizing ECT treatments and improving standard of care. 
2.
Background
Historically it was thought that inducing a seizure was all that was needed to produce 
the clinical effects seen in ECT, but multiple studies across the past 8 decades have 
shown varying rates of efficacy and severity of side effects based on ECT stimulus 
parameters. We learned empirically that electrode placement (bitemporal versus 
unilateral) and stimulus parameters that affect electrical pulse and pulse train matter 
[10]. However, practitioners continue to focus on total charge as the primary metric, 
largely ignoring the role individual stimulus parameters play in the equation. 
A biomarker of 
treatment response 
would help in 
evaluating clinical 
efficacy and 
accelerate evaluation 
of individual ECT 
parameters. There 
have been many 
potential biomarker 
for depression 
including hormones, 
cytokines, and neuro-
imaging. These 
investigations have 
been met with disappointing results [11]. EEG has also been evaluated as a potential 
biomarker in ECT, and there have been several advances that warrant a revisit to 
this line of inquiry. Firstly, traditional EEG filters out low frequency bands. Our 
preliminary data shows large infra-wave phenomena suggesting significant inhibitory 
activity (see figure 1) using dcEEG. This newly-captured neuronal activity during 
ECT could act by itself or in conjunction with ictal and postictal phenomena observed 
in normally observed frequency bands as a potential biomarker of treatment 
adequacy. Secondly, the EEG we propose is 24-lead, whereas prior investigations 
used up to 19-lead [12-14]. Our group has noticed more pronounced infra-slow 
waves in a subsection of the leads, meaning with greater resolution, we may be 
picking up neuronal activity that was previously missed. Thirdly, the studies 
evaluating EEG were carried out before ECT parameters were optimized with 
respect to seizure efficiency (high frequency and short pulse train duration). Current 
ECT devices have improved parameter ranges to individualize and optimize clinical 
outcomes.
3.
Study Design
Figure 1: 24-Lead ECT capturing spreading depression (box with arrow)


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This single-site clinical investigation will use assessments before, during and after the 
ECT series.  At the first time point (T1), subjects will be randomized to ketamine or 
methohexital induction.  The second time point (T2) will be the second ECT treatment. 
The third time point (T3) will occur midpoint, and the final time point (T4) will be the 
endpoint at the last ECT treatment. The patient will be blinded to the anesthetic.
4.
Inclusion and Exclusion Criteria
Inclusion Criteria, Major Depressive Disorder (MDD) & Bipolar Disorder (BPD)-
Depressed: 1) Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD 
or BPD-depressed (with or without psychotic features); 2) the clinical indications for 
ECT including treatment resistance or a need for a rapid and definitive response; 3) 
Hamilton Depression Rating Scale 24-item (HDRS-24) > 21; and 4) age range 
between 18 and 65 years of age. Per UNM ECT clinical service recommendations, 
subjects will be requested to taper and dc scheduled psychotropic medications with the 
exception of as needed medications for sleep or anxiety.
Exclusion Criteria: 1) Defined neurological or neurodegenerative disorder (e.g., 
history of head injury with loss of consciousness > 5 minutes, epilepsy, 
Alzheimer’s disease); 2) other psychiatric conditions (e.g., schizophrenia, 
schizoaffective disorder, bipolar disorder); and 3) current drug or alcohol use 
disorder, except for nicotine and marijuana 4) adults unable to consent, pregnant 
women, prisoner; 5) Have contraindications to methohexital and ketamine as described 
in the package inserts; 6) non-English speakers; 7) Patients that cannot tolerate 
Methohexital and Ketamine.
5.
Number of Subjects
26 subjects meeting the inclusion criteria will be recruited for this investigation. 
Our total sample size (n = 26) allows for a conservative 15% attrition rate leaving a 
final sample size of 22. This recruitment rate of 26 subjects per year will complete 
subject recruitment 1 year after study initiation. Sample size calculation is based on 
the 2004 Perera et al. paper examining ictal power between a threshold group and 
suprathreshold group (Cohen’s d = 1.19) with variances of .24 and .25 respectively. 
Assuming a power of .8 and a two-sided alpha (.05), we will need 11 patients in each 
group to adequately power our analysis, which is in line with our recruitment 
projections.
6.
Study Timelines
Individual subjects will have 4 points (T1-T4) in the study with the endpoint being 
their last treatment. ECT is done three times weekly and a typical series includes 8-
12 treatments. This means that patients will be enrolled and participating in research 
for approximately one month. The study period will be one year long with an 
additional three months for analysis for a total of 15 months.
7.
Study Endpoints
The primary endpoints include change in depression rating scale. Changes in 
depression rating will be compared with total ictal power and postictal suppression 
along with presence and power of infra-slow waves on dcEEG.  
8.
Research Setting
Patients will be recruited through the UNMH ECT consult service. All data collection 
will take place at the UNM Center for Psychiatric Research, or the ECT service at the 
University of New Mexico. All clinical assessments and neuropsychological testing will 
be conducted in an interview room or in a private patient room. 
9.
Resources Available


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Investigators: The PI (Dr. Miller) is a board-certified Psychiatrist and Assistant 
Professor at UNM. He has been on the neuromodulation service and doing ECT for 
two years. He has a recent publication on electrode placement and ECT. He has .5 
FTE devoted to completing this project as this constitutes his Master’s Thesis in the 
MSCR program. He plans to apply to the CTSC for pilot grant funding.
10. Prior Approvals
Departmental Review Form signed by Department Chair uploaded into Click under 
“supporting documents.”
11. Multi-Site Research
NA
12. Study Procedures 
Clinical Assessments: The primary clinical response measure will be change in the 
QIDS C and QIDS SR [15]. The trained clinical rater will use the structured interview 
for the HDRS-24 to examine inter-rater reliability [16]. The initial visit will also include 
the Maudsely Staging Method Form for treatment resistance [17], ECT 
Appropriateness Scale to assess the indication for ECT [18], Medical History form to 
gauge overall medical burden, and Edinburgh Handedness Inventory [19]. 
Neuropsychological Assessments: The Montreal Cognitive Assessment, a measure 
of global cognitive function that is sensitive to gross neurocognitive abnormalities, 
will be used for screening for preexisting cognitive impairment [20, 21]. The Dot 
Counting Test will measure effort. The Test of Premorbid Function estimates 
premorbid intellectual function [22] that will be used as a potential covariate in 
analyses. The Autobiographical Memory Test will assess free recall and retrieval 
patterns (specific versus general) of retrospective autobiographical memories [23-
25]. The Hopkins Verbal Learning Test-Revised (HVLT-R) will measure learning 
strategies, free recall, and recognition memory [26]. The Delis Kaplan Executive 
Function System (DKEFS) Color-Word Interference and Verbal Fluency Test 
measures processing speed, sequencing and cognitive flexibility [27-31]. To 
minimize practice effects, we will use three different published versions of the 
HVLT-R at each time point [32]. Also, we will construct a reliable change index for 
all cognitive variables of interest [33].  Following published guidelines, we will 
compute the HVLT-R percent retention score, which will be our primary outcome 
measure [34]. The percent retention score is a useful measure of hippocampal 
dependent memory function that reduces the possibility of over-estimating memory 
function from immediate and delayed free recall scores [34]. The entire 
neuropsychological battery (completion time < 60 minutes) will be used to compute 
composite z-scores that represent global cognitive function at each time point for 
secondary analysis.
ECT: The treating anesthesiologist will determine the appropriate dose for this 
procedure. The anesthetic agents include methohexital and ketamine, general 
anesthetics, and succinylcholine, a depolarizing neuromuscular blocker. Subjects will 
be randomized into methohexital and ketamine arms prior to the first ECT treatment. 
Both induction agents are considered standard of care during ECT. The first ECT 
session will determine individual seizure thresholds to ensure subsequent treatments 
are delivered at supra-threshold intensities. Motor, electroencephalographic and heart 
rate parameters will be recorded for each treatment.
Study Protocol: Subjects will receive their baseline depression and cognitive 
assessment 0 to 48 hours prior to the first ECT session (T1). One day after the sixth 
ECT treatment (T3), subjects will receive their second depression and cognitive 
assessment. Treatments will continue thrice weekly until clinical response, which 


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typically occurs between six and twelve treatments. The final assessment will occur 
after their last ECT treatment in the series (T4) and will include depression and 
cognitive assessments. DcEEG data will be collected at T1-T4 using a non-invasive 
cap that covers the patient’s head. Per standard of care, change of electrode 
placement will be assessed at the midpoint (T2) by the treating psychiatrist. If the 
patient is not responding to ECT they may be switched from RUL to bitemporal 
placement. This assessment will not be affected by the research protocol.
13. Data Analysis
See effect size calculation in question #5 for hypothesis 1.1. To the best of our 
knowledge, spreading depression has never been studied in ECT (aside from our 
preliminary findings). We will use the effect size for hypothesis 1.1 to guide us.
In terms of analyzing the mean power of the waves noted, we plan to calculate the 
sum of the mean power per epoch across T1-T4 data points to get total ictal power, 
as well as smaller epochs to calculate total infra-wave power and post-infra-wave 
suppression. We will also use chai2 to compare number of infra-slow waves and t-
tests to compare power of infra-slow waves and total ictal power of seizures and 
post-ictal suppression in the methohexital group. We do not expect to see infra-slow 
waves in the ketamine group.
14. Provisions to Monitor the Data to Ensure the Safety of Subjects
Methohexital and ketamine are both standard of care anesthetic agents used in ECT 
and the dcEEG device is worn on the scalp and is non-invasive. If the patient does 
not tolerate the anesthetic chosen, then they will be switched to the other anesthetic 
and act as a cross-over cohort. The medications and ECT device used in this study 
are standard of care. In the unlikely event that at the midpoint assessment (6 
months) greater than 50% of patients have refused to wear the EEG cap, our study 
will not be sufficiently powered and will be terminated.
15. Withdrawal of Subjects
If at any time a participant decides to withdraw from the study, the participant will be 
debriefed by the study coordinator or principal investigator as to the reason for their 
withdrawal. The participant will then be thanked for their time and 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
Some mental health information will be retained, including primary diagnosis and 
results of scales/cognitive tests. Patient will be made aware at time of consent that 
data will be de-identified immediately and stored in a secure location, and that data 
used in final analysis will not have any identifiable markers and will be de-linked at 
close of study. Records will be kept strictly confidential and will not be inspected by 
any other agency unless required by law. Data will be de-identified as appropriate to 
the UNM Human Research and Review Committee and HIPPA requirements by 
assigning a randomized eight-digit number to each participant upon entry into the 
study. This number will be used for all correspondence between study investigators 
and all data collection and analysis after the initial screening visit. Any personal 
information entered into computers is password protected and monitored for 
suspicious activity. In order to contact subjects for telephone visits and/or other 
matters, it will be necessary to retain names and telephone numbers of active subjects. 
However, these direct identifiers will not be stored with any clinical data or subject 
information in order to protect confidentiality. Any direct identifiers will be stored in 


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locked cabinets and in password-protected databases, separate from any clinical data. 
These will only be accessible by key study personnel. A link between study code 
numbers and direct identifiers will be retained in order to contact subjects for visit 
appointments or at a later date to inform them of newly received information. This link 
will be retained for the duration of the study. Subjects will be identified only by unique 
Patient ID numbers in Case Report Forms (CRFs) and electronic CRFs. The CRFs 
will be maintained in a locked cabinet housed in the Center for Psychiatric Research. 
These documents will only be accessible by authorized study staff and will comply with 
HIPPA requirements for the storage of health information. Moreover, all information 
will be in double-locked rooms per HIPAA specifications. At the time of study closure, 
all participant identifiers (name, address, etc.) will be made inaccessible to the 
research team. The results of this research may be presented at meetings or in 
publications; however, participants’ identity will not be disclosed. The participant will 
be provided with a copy of the consent form to take home upon request.
Devices:
MECTA Spectrum 5000Q (Electroconvulsive Therapy): The UNM ECT service has 
two MECTA 5000Q ECT machines for inpatient and outpatient ECT services.
 
Stimulus output
           Current: 800 mA constant current, limited to 450volts
•  Frequency: 10 to 120 Hz, in 10 Hz increments
•  Pulse width: 0.3 to 1.0 ms, in 0.25 ms increments
•  Duration: 0.50 to 8.0 s
•  Maximum output: standard maximum output 576 mC Recording Channels
•  Channels 1 & 2, EEG Stimulus Generation
•  Waveform
•  Bipolar
•  Brief pulse
•  Square wave
dcEEG: The 24-channel EEG monitoring (https://mbraintrain.com/smarting/) will 
include the low frequency range (< 0.01). EEG set-up will be facilitated with the use 
of a skull cap that includes the multi-channel electrodes. The EEG signal will be 
digitally recorded for approximately 30-minutes (pre- and post-ECT) and transferred 
to a dedicated device over Bluetooth. This dedicated device will not be on the 
network.
17. Data and Specimen Banking
Data will be stored in locked cabinets at the UNM Center for Psychiatric Research. 
Subjects' charts will be stored without direct identifiers. Only research staff designated 
by Dr. Miller will have access to these records. In order to contact subjects for 
telephone visits and/or other matters, it will be necessary to retain names and 
telephone numbers of active subjects. However, these direct identifiers will not be 
stored with any clinical data or subject information in order to protect confidentiality. 
Any direct identifiers will be stored in locked cabinets and in password-protected 
databases, separate from any clinical data. These will only be accessible by key study 
personnel. A link between study code numbers and direct identifiers will be retained in 
order to contact subjects for visit appointments or at a later date to inform them of 
newly received information. Information collected will be labeled with a study number 


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and will be entered into a computer database that is password protected. The data will 
be stored on the MRN computer network and compact disks, and will be destroyed 5 
years after publication. Clinical and research data will be de-identified after the study 
is complete and closure documents are submitted to the UNM IRB. The de-identified 
clinical data will be kept indefinitely for research purposes.
Electronic Data: Collaborative Neuroinformatics Suite (COINS). This web-based 
neuroimaging and neuropsychology software suite offers versatile, automatable data 
upload/import/entry options, rapid and secure sharing of data among PIs, querying 
and export all data, real-time reporting, and HIPAA and IRB compliant study-
management tools suitable to large institutions as well as smaller scale neuroscience 
and neuropsychology researchers. Network is accessed on a secure server and has 
firewalls in place. Controlled access is granted to only study team members.
De-identified information will be available at the Mind Research Network Data Sharing 
Repository for future research. Both the NDA and Mind Research Network Data 
Repositories are clearly described in the “Data Sharing” section of the consent form. 
18. Risks to Subjects
Participation in this study may involve minimal risk and/or discomforts associated 
with repeated cognitive testing and the time taken to place the dcEEG cap on their 
head prior to treatment at four different time points (T1-T4). The anesthetic agents 
are both standard of care in ECT. There is a risk of side effects with these 
medications, but these risks are no higher than if they were not in the study.
19. Potential Benefits to Subjects
There is no anticipated benefit for subjects.
20. Recruitment Methods
The UNM ECT Treatment Program receives referrals from inpatient and outpatient 
providers at the UNM Mental Health Center. The treatment team will clinically 
determine who will be eligible for the study and document this in the subject’s study 
records. The research team will only approach patients for the study protocol that have 
been identified by the primary treatment team. Patients diagnosed with Major 
Depressive Disorder and Bipolar Disorder currently Depressed are eligible for ECT 
treatment will be recruited from the UNM ECT Treatment Program. 
21. Provisions to Protect the Privacy Interests of Subjects
From the standpoint of privacy and confidentiality, the subject's welfare will be 
safeguarded by responsible, systematically controlled procedures in the collection of 
information for both clinical and research purposes. Subjects may refuse to answer 
any question at any time. Recorded information for research purposes will be identified 
only by subject initials and a study code number. Subject data will be kept in locked 
cabinets in the research clinic with limited access granted only to designated research 
personnel. These processes will be in place throughout the entire research process, 
from initial consenting to research, through research procedures, and follow-up. The 
study PI will maintain confidentiality of all records to the extent permitted by applicable 
laws. 
22. Economic Burden to Subjects
Subjects will be not placed under economic burden due to this trial.
23. Compensation
This study will require data gathering at 4 points (T1-T4). Subjects will be compensated 
$50.00 for completion of wearing the dcEEG cap. They will receive $50.00 for 
participating in the cognitive and depression assessments for each visit (up to 3 visits). 
The most compensation a patient can receive is $200.00. The compensation is for the 


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extra time for EEG preparation and neuropsychological assessments. All 
compensation will be given in the form of a merchandise card.
Compensation for Research-Related Injury
UNMHSC will provide subjects with emergency treatment, at their own cost. No 
commitment is made by the University of New Mexico Health Sciences Center 
(UNMHSC) to provide free medical care or money for injuries to participants in this 
study. In the event that you have an injury or illness that is caused by a subject’s 
participation in this study, reimbursement for all related costs of care will be sought 
from their insurer, managed care plan, or other benefits program. If the subject does 
not have insurance, they may be responsible for the costs. Subjects will also be 
responsible for any associated co-payments or deductibles required by their 
insurance.
24. Consent Process
Discussion of the proposed study will occur separate from the evaluation for the ECT 
procedure. Potential subjects will have ample time to ask questions regarding the 
nature of this study and will be clearly informed that this imaging investigation is 
optional. Informed consent will be discussed with each participant with plenty of 
opportunities to ask questions. The study PI (Miller), a board-certified psychiatrists will 
assess decisional capacity for each subject during the consent process. The PI has 
experience with the assessment of decisional capacity in both research and clinical 
domains. Patients with decisional capacity will provide written informed consent for 
study participation. Subjects who do not have decisional capacity will not be included 
in this investigation.
Subjects who are not yet adults (infants, children, teenagers
NA
Waiver or Alteration of Consent Process (consent will not be obtained, 
required element of consent will not be included, or one or more required 
elements of consent will be altered) 
NA
25. Documentation of Consent
Notes will be kept to document the informed consent process. Narratives will be 
completed by study staff noting how subjects were referred for research, contact dates, 
questions asked during the consent process, subject understanding, and the dates 
they reviewed and signed the consent. Narrative forms will be securely filed with other 
subject information to document each visit and contact, in addition to required study 
measures and procedures. Subjects will be given a copy of their signed consent form 
and HIPAA. A member of the research team will review the HIPAA authorization during 
the consent.
26. Study Test Results/Incidental Findings
Depression, cognitive, and dcEEG data will be shared with the patients. There are no 
potential incidental findings noted.
27. Sharing Study Progress or Results with Subjects
As above, the dcEEG, cognitive and depression assessment results will be shared 
with the patient. There will be no summary provided to the patient with research 
information at the end of the study.
28. Inclusion of Vulnerable Populations
Sample inclusion will not include gender restrictions.  It is expected that our sample 
will reflect the gender distribution of our ECT service over the last 5 years. Recruitment 


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will reflect the demographics of the state of New Mexico. Prisoners and pregnant 
women will be excluded from the study. The age range of 18 to 65 years was selected 
to limit the variability of age-related volume changes. Subjects with pre-existing 
diagnoses of neurodegenerative diseases or cerebrovascular pathology will be 
excluded. Dr. Miller (PI) will assess decisional capacity of all subjects participating in 
this investigation. Subjects that do not have decisional capacity for this investigation 
will not be included.
Community-Based Participatory Research
NA
29. Research Involving American Indian/Native Populations
The proposed research inclusion criteria will be open to all patients with major 
depressive disorder and bipolar disorder meeting the inclusion criteria. The UNM ECT 
service is part of a tertiary referral service and the demographics of this service reflect 
the state of New Mexico. This investigation will not have targeted recruitment outside 
of routine clinical referrals to the UNM ECT service.
30. Transnational Research
NA
31. Drugs or Devices
Methohexital: FDA approved for anesthesia
Ketamine: FDA approved for anesthesia
Mecta 5000q: FDA approved for ECT with 2-channel FP1 FP2 EEG capabilities for 
clinical decision making
SMARTING EEG
32. Principal Investigator’s Assurance
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that:
☒ The information supplied in this form and attachments are complete and correct.  
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements. 
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security 
Best Practices, including:
1.
Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap.
2.
Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include 
if the data is entered or stored using an untrusted device or storage.
3.
Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to 
be carried out in such a way as to avoid creating/retaining files on untrusted 
storage devices/computers. Trusted devices are HSC managed and provide one 
or more of following safeguards: access logs, encryption keys, backups, 
business continuity and disaster recovery capabilities.


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4.
Alternate storage media must be approve by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards.


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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
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).
1.
Will you be recording any PHI when conducting the records review to identify 
potential subjects and/or determine eligibility?
 Yes. Describe: Patient’s primary mental health diagnosis, age
 No
2.
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:
Patient information will be de-identified at time of enrollment, when they will 
be assigned an 8 digit number. The linking file will be stored separately from 
the de-identified information in a secure location.
3.
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


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1.
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therapy: a review of determination and clinical relevance. J ECT, 2006. 22(3): p. 213-7.
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5.
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