tDCS for Chronic Low Back Pain: A Study Examining the Effect of Transcranial Direct Current Stimulation on the Emotional Response to Chronic Low Back Pain
Phase: NA
Conditions: Chronic Low Back Pain
Sponsor: Butler Hospital

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IRB # 1411-003                         
BUTLER HOSPITAL 
INSTITUTIONAL REVIEW BOARD  
 
BUTLER HOSPITAL IRB NEW SUBMISSION FORM 
  
For: (check one) 
☑ Protocol for Research Involving Human Subjects: Complete Sections 1-4 & 6-9 
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6 & 7 
☐ Waiver of Authorization for use of Protected Health Information (PHI) Preparatory to 
Research: Complete 1, 6 & 7 
  
Protocol Status: ☑ New  ☐ Renewal   -or-    Authorization Waiver Status:   ☐ New   ☐ Renewal   
1.) TITLE OF PROJECT:       tDCS for Chronic Low Back Pain: A Study Examining the Effect of 
Transcranial Direct Current Stimulation on the Emotional Response to Chronic Low Back Pain    
 
Principal Investigator (P.I.)(s):  Benjamin Greenberg, M.D., Ph.D. 
Signature(s) of the P.I.(s):  
Other Investigator(s):  Timothy Mariano, M.D., Ph.D., Michael Stein, M.D.                                                                  
Corresponding Investigator:  Timothy Mariano, M.D., Ph.D                                                                                         
Mailing Address: C/O OCD Research; Butler Hospital 345 Blackstone Blvd., Providence RI  02906                           
Telephone/FAX/E-mail:  401-455-6610 / timothy_mariano@brown.edu                                           
                         
Funding: (Source, PI): Internal Funding                                                                                                                         
Duration of Project:     1 year  Duration for Individual Subjects: (if waiver: n/a)   2 months                                      
Specific Location(s) of Project:  Butler Hospital                                                                                                           
 
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Check if requirements have been met (submit written explanation if “no”):                                      
 
 
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ATTENTION: 
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Download the most recent version of this and any other needed IRB forms 
and consult the IRB Guidelines for updated directions. 

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2.) Description of Study 
The goal of this study is to investigate the role of central neural pathways in mediating chronic pain. 
The aim of the study is to test the effect of stimulating brain regions that are part of a network 
underlying central pain processing using a non-invasive brain stimulation technique, transcranial 
Direct Current Stimulation (tDCS).  Prior studies have used tDCS to target both sensory related 
cortical areas (Fregni 2006) and those important for higher-order representations of pain (Mendonca 
2011). This study will target brain regions important for the behavioral response to the chronic 
sensation of pain. The hypothesis is that stimulation of these brain regions can modulate not only the 
affective component of pain, but ultimately also improve functioning and quality of life.  This 
hypothesis will be tested by treating study participants eighteen and older with chronic low back pain 
(CLBP) of greater than six months using tDCS. To be part of this study, participants must meet all 
the inclusion and exclusion criteria. 
 
A.  Specific Aims 
 
The aim of the proposed study is to determine effects of tDCS on the affective and behavioral 
component of chronic pain. The study will specifically target the dorsal anterior cingulate cortex 
(dACC), an important component of brain circuits that mediate learning in response to emotionally 
charged experiences. Measures of distress will be obtained due to the sensory component of pain to 
assess the degree to which pain interferes with the participants’ daily activities, and the emotional 
impact of CLBP on their lives. 
Aim 1 To test the acute effects of active vs. sham cathodal (inhibitory) tDCS over dorsal anterior 
cingulate cortex (dACC), a region implicated in the affective components of pain in twenty (20) 
patients in a controlled design.  
Hypothesis: Acute Effect 
Hypothesis 1.1 
Distress associated with pain as measured by the West Haven-Yale Multidimensional Pain 
Inventory (WHYMPI) (affective subscale) and pain anxiety symptom scale (PASS-20) will 
decrease after ten (10) days of active but not sham stimulation. 
Hypothesis 1.2 
Pain-related avoidance and disability measured on WHYMPI (interference subscale), PASS-
20, and Rolland-Morris Disability Questionnaire (RMDQ) will decrease after ten (10) days of 
active but not sham stimulation. 
Hypothesis 1.3 
The perceptual component of pain, measured with the Defense & Veterans Pain Rating 
Scale (DVPRS) will not change 
Aim 2 To test the longer term effects of active vs. sham cathodal (inhibitory) tDCS over dACC in the 
same twenty (20) patients in a controlled design.   
Hypothesis: Longer Term Effect 
Hypothesis 2.1 

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Distress associated with pain as measured by the WHYMPI (affective subscale) and PASS-
20 will remain decreased at follow-up. 
Hypothesis 2.2 
Pain-related avoidance and disability measured on WHYMPI (interference subscale), PASS-
20, and RMDQ will remain decreased at follow-up. 
Hypothesis 2.3 
The perceptual component of pain, measured with the DVPRS will not change. 
 
B.  Background 
 
Chronic pain is one of the single most challenging problems facing medicine. Costs 
associated with treating chronic pain and the resulting disability may exceed the combined cost of 
treating patients with coronary artery disease, cancer, and AIDS (Turk 2002). Of patients with 
chronic pain, the most prevalent syndrome is CLBP.  Current treatments for CLBP consist mostly of 
opioid and non-steroidal anti-inflammatory medications that have been largely unsuccessful in 
curbing the growing societal cost of pain syndromes and providing long-term relief for patients. In the 
study proposed, the study investigators will test the efficacy of a novel approach to modulating brain 
areas important for processing the emotional dimension of pain. 
Recent studies of chronic pain have suggested that the sensation of pain can give rise to 
maladaptive avoidance behavior, and it is these behaviors that contribute to a significant part of 
pain-related disability. It has been posited that an adaptive mechanism exists for avoiding activities 
that result in further sensation of pain.  In the short-term, this mechanism may protect a person from 
further injury.  Continued avoidance of potential pain triggers, however, ultimately results in 
avoidance and discontinuation of daily activities that provide positive life experience, needed 
physical activity, and social support.  This pattern of behavior ultimately leads to continued physical 
deconditioning, social isolation, and depressed mood (Crombez 2012), factors contributing to a 
higher risk of anxiety, depression, and suicide.  In this study, we propose stimulation of brain regions 
underlying the emotional component of pain, with the goal of interrupting the continuation and 
reinforcement of this cycle of maladaptive behavior. 
Multiple interconnected brain regions are implicated in pain processing (Mackey 2004; 
Borsook 2010). These include areas of the brain directly responsible for processing sensory input 
such as the thalamus, primary and secondary somatosensory cortices, and regions important for 
mediating cognitive aspects of pain processing, such as dorsolateral prefrontal cortex (DLPFC), 
dorsal anterior cingulate cortex (dACC), medial and ventromedial prefrontal (mPFC and vmPFC, 
respectively), orbitofrontal (OFC), and insular cortex. The investigators will target those brain regions 
that play a role in emotional salience of pain processing. Specifically, our initial efforts will inhibit the 
activation of dACC. We posit that reducing the activity in dACC will decrease the emotional saliency 
of pain, impacting the degree to which CLBP causes disability. 
The role of anterior cingulate cortex (ACC) in mediating pain processing is well supported.   
First, a mainstay treatment for chronic pain includes opioid medications. Though these medications 
act in multiple brain regions, ACC exhibits one of the highest densities of opioid receptors in the 
brain and is a primary site of action for these treatments (Vogt 1995). Second, selective surgical 
lesion of the cingulate cortex has been used to treat chronic pain since the 1960s. Importantly, 
following surgery, though patients reported still experiencing the pain, they were less bothered by it 
(Eisenberger 2004; Folzt 1968). This response supports the role of ACC in the affective component 

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of pain processing. It is the goal of this study to determine whether a similar dissociation between 
the sensation of pain and the distress related to pain can be elicited by stimulating dACC using a 
non-invasive method, tDCS. 
Transcranial direct current stimulation, or tDCS, is classified by the FDA as a minimal risk 
technique. tDCS applies low amplitude direct current to the scalp to modulate the excitability of 
underlying cortex. Several studies have shown promising results treating acute pain, neuropathic 
pain resulting from spinal cord injury, and chronic pain from fibromyalgia (Antal 2008; Lefaucher 
2008; Fregni 2006). As in these studies, tDCS will be used to target areas of the brain that 
participate in pain processing at higher levels beyond simply relaying sensory information. By 
changing activity in the “affective tier” of brain networks implicated in responses to pain, the 
investigators expect to modify emotional responses and behaviors that add to its burden. 
 
C.  Experimental Method 
 
C1. Brief Description of Subjects 
 
Participants will be aged over 18 years old with a diagnosis of chronic low back pain based 
on the inclusion criteria (see below) by a referring physician.  Participants will be of any racial or 
ethnic group and of either sex.  A questionnaire will be administered to screen for possible 
contraindications for tDCS (see exclusion criteria). We will consent up to thirty (30) volunteers with a 
goal of enrolling twenty (20) participants, ten (10) in the treatment group and ten (10) in the control 
group. 
 
C2. Study Design 
 
The study includes a screening visit, ten (10) study treatment session visits on consecutive 
weekdays and a follow-up phone call, approximately six (6) weeks after the last study visit. The ten 
study visits will occur at Butler Hospital and will take between two (2) to two and half hours (2 ½) 
hours. The total duration of this study for the participant is expected to be up to approximately 
twenty- four (24) hours; this includes the consent process, screening and eligibility assessments and 
ten research visits which will include the study treatment, tDCS, completion of study related 
questionnaires, and the follow-up phone call. 
Half of the participants will receive only sham stimulation for all treatment days (days where 
tDCS is applied) and half will receive only active stimulation; this will be randomly assigned.  
Comprehensive measures of distress resulting from CLBP will be administered to assess both the 
short and longer term effects of tDCS treatment. Participants and research staff administering 
outcome scales will be blinded to active vs. sham tDCS.  
  
C3. Specific Procedures or Treatments 
 
After the potential participant signs the consent form, is screened, found eligible and states they are 
still interested they will be enrolled into the study. 
 
Questionnaires: Table 1, below identifies the schedule for when the study questionnaires 
will be used. All questionnaires will be done with assistance of blinded study personnel. 

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Pain Severity: This study will use the 11-point numerical scale  
http://www.dvcipm.org/files/manuals-resources/dvprs.pdf for rating pain intensity developed 
by the Office of the Army Surgeon General Pain Management Task Force (2010).  0 
indicates no pain and 10 indicates the most severe pain. This will be administered on 
screening, before and after each treatment session, and at follow-up. 
Pain Interference: Two measures will be used to assess pain interference.  First, the West 
Haven-Yale Multidimensional Pain Inventory (WHYMPI) (Kerns 1985) will be used as a 
measure of the chronic pain experience.  The interference sub-scale will be used to measure 
perceived interference of pain in vocational, social/recreation, and family/marital functioning.  
Second, we will use the Rolland-Morris Disability Questionnaire (RMDQ) to assess disability 
specific to back pain (Roland & Morris 1983).  The RMDQ is widely used and has acceptable 
psychometric properties (Roland & Fairbank 2000). 
 
Pain Acceptance: We will assess pain acceptance with the Chronic Pain Acceptance 
Questionnaire-8 (CPAQ-8) (Fish et al 2010).  This measure addresses the ability to 
experience ongoing pain but continue engaging in enjoyable daily activities that are not 
focused on avoiding or reducing the pain.  This measure has good psychometric properties 
(Rovner et al. 2014) 
 
Emotional Distress: Investigators will employ a battery of measures to determine the 
degree to which participants experience emotional distress resulting from pain.  First, the 
affective sub-scale of the WHYMPI will be used to measure negative emotion related to pain.  
Second, the General Anxiety Disorder 7-item scale (GAD-7) will be used to assess general 
anxiety symptoms.  Third, the Patient Health Questionnaire (PHQ-9) will be used to assess 
depressive symptoms (Kroenke 2001).  The PHQ-9 is a quick self-report measure 
demonstrating reliability and validity in primary care settings (Spitzer 1999).  Lastly, we will 
include the short form of the pain anxiety symptom scale (PASS-20) to measure fear and 
avoidance behavior related to pain (McCracken & Dhingra 2002). 
Patient Expectation and Satisfaction: We will assess treatment credibility and patient 
expectations for treatment success using the Credibility Expectancy Questionnaire (CEQ; 
Devilly & Borkovec 2000).  The Client Satisfaction Questionnaire-8 (CSQ-8; Larsen, 
Attkisson, Hargreaves, & al., 1979), an 8-item scale, will be used at post-treatment to assess 
patient satisfaction with the treatment. This scale has acceptable psychometric properties 
(Nguyen, Attkisson, & Stegner, 1983). 
Psychiatric History: Drug related problems, exclusionary disorders, and other non-
exclusionary psychiatric disorders will be assessed with a structured psychiatric interview, 
the Mini International Neuropsychiatric Interview (MINI). This is a validated interview 
designed to screen for Axis I disorders. Potential participants that are determined by the 
MINI to have lifetime diagnoses of bipolar disorder, schizophrenia, other chronic psychotic 
condition(s), and/or drug or alcohol dependence will be considered screen failures. 
  

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Sleep Measure: An in-office assisted report of sleep will be used to assess quantity and 
quality of sleep throughout the ten testing days of the study. The questions used to assess 
sleep have been based on those used in the 1992 Carskadon Sleep-Wake Diary. 
  
Table 1. Schedule of Assessments 
  
Purpose 
Consent 
and Screen 
First Day 
of Week 
One 
Session 
1 
Pre/Post 
Treatment 
Session 
1-10 
End of Week  
One and Two 
Session 
5 & 10 
Six Week 
Follow-up 
Pain Severity 
Defense & Veterans 
Pain Rating Scale 
(DVPRS) 
 
I, O 
 
X 
 
X 
 
X 
 
 
X 
 
X 
Pain Interference 
WHY-MPI 
RMDQ 
 
O 
O 
 
 
X 
X 
 
 
X 
X 
 
X 
X 
Pain Acceptance 
CPAQ-8 
 
O 
 
 
X 
 
 
X 
 
X 
Emotional Distress 
PHQ-9 (Depression) 
GAD-7 (Anxiety) 
PASS-20 (Pain related 
fear/avoidance) 
 
O 
O 
O 
 
 
X 
X 
X 
 
 
X 
X 
X 
 
X 
X 
X 
Psychiatric History 
MINI 
 
I 
 
X 
 
 
 
 
 
Sleep Measure 
Sleep assessment 
O 
 
X 
X 
X 
X 
Patient Expectation and 
Satisfaction 
CEQ 
CSQ-8 
 
T 
T 
 
 
 
X 
X 
 
 
 
X* 
X* 
*(only session 10) 
 
Assessment instruments are used for the following purposes: I= Inclusion criteria; T = 
Treatment Development Target Assessment; O = Outcome Measure 
Links to the measures, when available: 
DVPRS 

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WHY-MPI 
RMDQ 
CPAQ-8 
PHQ-9 
GAD-7 
PASS-20 
CEQ 
CSQ-8 
  
Study Visits: All participants will be clearly directed to the building and room where the 
study procedures will occur prior to each visit. All study visits will occur at Butler Hospital in a 
research room. 
On the first day of treatment, prior to the tDCS treatment, females of childbearing age 
will be required to have a urine pregnancy test (hCG dipstick) before any study procedures. 
The test will be administered by a trained member of the research staff overseen by Dr. 
Greenberg or another licensed physician. Any participants that show a positive pregnancy 
test will be considered a screen failure. 
Participants will be asked to complete the DVPRS, WHY-MPI, RMDQ, CPAQ-8, 
PHQ-9, GAD-7, PASS, CEQ, CSQ-8, and the Sleep Measure.  This will provide a baseline 
measure in regards to the sensory/perceptual component of their pain, the degree to which 
pain interferes with daily activity, and the emotional component of their pain.  
Prior to this and each study treatment, designated research staff will assess the skin 
on the participant’s scalp where the electrodes will be placed to assure there are no lesions, 
cuts, or exclusionary skin disorders. Participants will be positioned for optimal comfort on a 
chair, recliner or stretcher. Designated trained research staff will attach the electrodes to the 
participant’s scalp (participants will not need to have any hair shaved) and apply the flexible 
rubber headband to keep them in place. (See detail below). Participants will be educated that 
research staff will be monitoring them continuously through a non-recording closed-circuit 
camera from another room or he/she will be physically present in the room to assess if they 
need anything or want to stop the tDCS. 
The participant will then receive either the sham or active tDCS stimulation based on 
their random group assignment for twenty minutes (tDCS details are below). Following tDCS 
stimulation, only the DVPRS will be repeated.  This measure will be used to determine 
whether immediate pain relief following stimulation occurs.  Lastly, in order to monitor the 
effectiveness of the blind, participants will be asked to guess which treatment, active or 
sham, they received.  
On subsequent treatment days, the DVPRS will be repeated before and after 
stimulation and the Sleep Measure will be repeated before stimulation. At the end of the first 
week of treatment, session five, in addition to the DVPRS and the Sleep Measure, the WHY-
MPI, RMDQ, CPAQ-8, PHQ-9, GAD-7, and the PASS, will be repeated. During the second 
week, the DVPRS will again be administered before and after each treatment, and the Sleep 
measure will be repeated before stimulation 
 On the final day of treatment, in addition to the DVPRS and the Sleep Measure, the 
WHY-MPI, RMDQ, CPAQ-8, PHQ-9, GAD-7, CEQ, CSQ-8, and the PASS, will be repeated. 

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Follow-up assessments will occur by phone approximately six (6) weeks after the last tDCS 
treatment session and will consist of these same measures as session ten.  
 
tDCS Details 
 
Equipment used for tDCS Intervention, the Neuroconn DC-STIMULATOR PLUS, is a 
micro-processor-controlled constant current source.  tDCS is a non-invasive procedure  in 
which a device sends a small Direct Current (DC) across the scalp to modulate brain 
function. A low-level current from the positive electrode, anode, is sent to the negative 
electrode, cathode. When the extremely low level current passes from the anode to the 
cathode, it may simultaneously increase the activity of the brain by the anode and decrease 
the activity of the brain near the cathode. The DC-stimulator meets the highest safety 
standards thanks to (hardware- and software-based) multistage monitoring of the current 
path. It continuously monitors electrode impedance and it can detect insufficient contact with 
the skin and automatically terminate stimulation to reliably prevent participant injury. 
The FDA recognizes the tDCS device as a non-significant risk device. During each 
treatment session, tDCS will be applied to the scalp using a Neuroconn DC- Stimulator.  
 
  
Figure 1. tDCS device 
Stimulation will be applied to the participant’s skull using metal electrodes seated in a 
flat, slightly perforated rectangular sponge pocket.  The sponges will be soaked in normal 
saline (0.9% NaCl) and affixed to the head on intact skin (after the scalp skin is cleaned with 
an alcohol prep pad) and held in place with a custom tDCS specific rubber headband. One 
set of sponges will be used for each participant. Standard conductive water based gel 
(Spectra 360 electrode gel) will be applied to the sponge (between the scalp and the sponge) 
only if the impedance is found not to be optimal, to improve current flow. In this experiment, 
only 1 stimulating electrode and 1 reference electrode will be used.  The investigators will 
target the dorsal anterior cingulate cortex by placing the stimulating electrode at FC1 on the 

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10-20 EEG system (see Figure 2). The reference electrode will be placed on the 
contralateral supra-auricular point, at T3 (see Figure 3). Point T3 will be located immediately 
above the superior tip of the participant’s pinna. Point FC1 will be located via scalp 
measurements: 50% of the way from the participant’s nasion to inion will be used as 
reference point Cz (see Figure 2), 33% from the nasion to inion will be used as point Fz, and 
50% of the way from T3 to Cz will be used as C3. FC1 will be 50% of the way from C3 to Fz.  
Active tDCS, i.e. anodal or cathodal, will be applied during the session.  The device will 
deliver a maximum of 2 mA (2.55 mA/cm2) of direct current stimulation for twenty (20) 
minutes which is controlled by a timer on the device. 
  
 
  
    Figure 2. 10-20 EEG System                    
Figure 3. 10-20 EEG System 
In the sham condition, the current paradigm will consist of 40 seconds of stimulation 
at 1mA and then 19 minutes and 20 seconds of stimulation averaging no more than 0.002mA 
This procedure allows for participants to detect the associated tingling sensation at the 
beginning of the session, making participants more likely to believe that they are receiving 
active stimulation and the short duration is not expected to have any effect on brain function.  
 
C4. Data Analysis 
 
The PI(s) will be responsible for and supervise data collection and data management. Data 
will be stored in a locked cabinet in the PI’s office. Data analysis will be conducted using standard 
statistical software including SPSS and R.  Data will be analyzed through linear models including 
(M)ANOVA, repeated measures analyses and mixed linear model procedures to deal with 
correlational effects. This will be followed by appropriate post-hoc analyses comparing specific 
conditions. In order to maintain anonymity in data files participants will be only listed with their 
unique identification code. Data backup of these files and hard copies of data capture forms will be 
kept in locked files to which only authorized study personnel will have access. Descriptive data will 
be provided for all participants (e.g., mean age, sex, education, etc.). Clinical rating scales will be 
scored as they are in clinical use. There is no power analysis as this is an exploratory study. 
 
D.  Material Inducements 

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Compensation for time and effort will be offered for the measures administered in this study.  
Participants will receive $60 as compensation for participation if they complete all 10 sessions of 
tDCS treatment.  If the participants withdraw from the study before finishing, they will receive $6 per 
session for each session in which they participated regardless if they were able to complete the full 
session. 
 
E.   Training of Research Personnel 
 
Prior to initiation of the study all research personnel will be trained in the specifics of this 
research project according to their role. Research personnel responsible for administering 
assessments and questionnaires will be trained by the PIs and Co-PIs. Ongoing training will occur 
as needed, especially if the study is amended and for review of the logistics and progress of this 
project. 
All research staff will have completed research ethics training; including data management 
and procedures for maintaining data confidentiality and safety before being allowed to work on the 
project.  Urine pregnancy tests will be done at Butler Hospital by a trained member of the research 
staff under the supervision of a licensed physician. 
 
 
3) Human Subjects 
  
A.  Subject Population (include number; gender; age; diagnosis; inpatient vs. outpatient;               
 
physical health; inclusion/exclusion criteria; rationale for use of special groups) 
 
To be eligible for participation in this study participants must be eighteen years or older with 
a diagnosis of CLBP chronic low back pain and meet the inclusion and exclusion criteria (see 
below). There are no exclusions based on race, ethnicity or gender. The plan is to consent up to 
thirty (30) volunteers with a goal of enrolling twenty (20) participants, ten (10) in the treatment group 
and ten (10) in the control group. 
 
Inclusion Criteria: 
1.  At least eighteen (18) years old; 
2.  Chronic Low Back Pain - must be present for ≥ 6 months duration in the lumbar region, 
present more than half  the days of the month, and on average be at a moderate level of 
severity in the last month (≥ 4 on the DVPRS scale of pain intensity from 0 (no pain) to 10 
(worst pain imaginable).  
3.  At least one trial of physician recommended medication (i.e. acetaminophen, NSAIDS, 
skeletal muscle relaxants) 
4.  Pre-existing opioid and non-opioid pain medication must be non-existent or stable 
(medications have not changed for one month) 
5.  Be able to understand, read and write English. 
6.  If female and of childbearing age, agree to use acceptable birth control during the study  

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treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a 
 
reliable barrier method) during the study treatment period. 
 
Exclusion Criteria: 
1.  Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic  
condition; 
2.  Current DSM-IV diagnosis of substance dependence for alcohol, sedative/ hypnotic 
drugs, stimulants, or cocaine; 
3. Current cancer, infection, or inflammatory arthritis 
4.  Broken skin or other lesions in the area of the electrodes 
5.  Uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or 
airway disease, heart failure, coronary artery disease, or any other condition that poses a 
risk for the subject during participation. 
6.  Presence of metal in the cranial cavity 
7.  Holes in the skull made by trauma or surgery 
8.  Pacemakers, medication pumps, and other implanted electronic hardware; 
9.  Pregnancy  
  
B.  Recruitment and Consent Procedures 
 
Recruitment will primarily take place through referral from Butler Hospital clinicians or 
community providers.  Advertisements will also be posted at Butler Hospital and online.  See 
appendix for a text of these advertisements.  Written informed consent will be obtained prior to 
clinical screening or administration of any measures or procedures.  The consent process will be 
administered in person by a member the study team who has received research ethics training. The 
study team member will assess whether the potential participant understands the study procedures, 
and will ensure that all questions related to the study are answered. Participants will be informed that 
they may discontinue their participation at anytime without penalty. 
After signing the consent form, potential participants will undergo further screening and 
collection of information with a trained research interviewer, designated by the principal 
investigators.  The interviewer will collect demographic information (ex. age, gender, height, weight, 
racial/ethnic group, years of education, contact information) and further screen for study inclusion 
and contraindications of tDCS.  The screening assessments are further detailed under specific study 
procedures. 
Screening is expected to take up to one and a half hours (1 ½).  The principal investigator/s 
will make the ultimate determination of whether the participant meets all the enrollment criteria and is 
appropriate to enter the study. Participants that do not meet the study criteria will be informed that 
based on the information collected, it has been determined they are not appropriate for the current 
study. 
 
C.  Potential Risks   
 
There are minimal risks to be incurred from participating in this study. Specific risks related to 
the clinical and cognitive assessments (study questionnaires) and tDCS are described below. 

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Participants may be uncomfortable sitting or lying for an extended period of time on the chair, 
recliner or stretcher due to their CLBP. 
Risks and discomforts due to Clinical and Cognitive Assessment Administration:  There are 
several questionnaires that the participant will be asked to answer. The time it takes to answer these 
questions may create frustration or fatigue.  Answering the clinical symptom rating questions may 
involve sensitive information that could cause emotional reaction, embarrassment or discomfort. 
Previously undisclosed or unknown mental health problems may be identified. 
Risks due to tDCS: There is some inherent risk with tDCS. Mainly there is a risk of skin irritation 
where the electrodes are attached to the scalp, which in the literature has been mostly limited to 
transitory redness. No toxic effects have been found, and the procedure carries few risks (Brunoni, 
et al., 2012). At the levels we are proposing, only a few publications report minor injuries, and the 
stimulation is widely considered to be “safe” (Bikson, et al., 2009). In rare cases, when skin around 
stimulation sites was non-intact, or when the stimulation was delivered for a long time without proper 
conductive solutions being applied to the electrodes, a few minor burns and skin lesions have been 
observed (Frank, et al., 2010). If electrodes/sponges are placed over preexisting skin lesions, such 
as vascular moles and angiomas there may be a greater conductance than the surrounding skin, 
increasing the risk of irritation or possible burns. Care is thus taken to exclude potential participants 
who exhibit broken or marked skin near the sites of the electrodes and to avoid abrading the skin 
prior to placing the electrodes (Loo et al. 2011). The electrodes in this study are soaked in normal 
saline. A study using the same amperage proposed in this protocol found no mood or cognitive 
changes due to tDCS (Iyer, et al., 2005). Transient, very rare post-tDCS effects have been found to 
include mild headaches, nausea, and insomnia (Poreisz, et al., 2007).  In a prior study conducted by 
Drs. Greenberg and Mariano, eight of 40 participants reported sensations of itching, tingling, or 
burning under the tDCS electrodes; one participant reported mild dizziness. These sensations were 
consistent with those commonly reported for tDCS (Brunoni, et al., 2012). Less well-studied is the 
possibility of negative effects of tDCS on cognition and mood.  A study using the same current 
amplitude as proposed in this protocol found no mood or cognitive changes due to tDCS, but this 
was with a single stimulation session (Iyer, et al., 2005).  Several studies have used multiple 
sessions of tDCS of different brain regions successfully to reduce pain intensity from acute pain, 
neuropathic pain, and chronic pain from fibromyalgia (Antal, et al., 2008; Lefaucher, et al., 2008; 
Fregni et al. 2006) without significant adverse effects.  Another potential concern is the risk of an 
undesired synergistic effect between a participant’s existing medication and tDCS. There are some 
reports in the literature of isolated instances of hypomanic or manic symptoms, typically noted with a 
longer treatment course than proposed in the current study or in patients with pre-existing bipolar 
diagnoses (Brunoni, et al., 2013; Galvez, et al., 2011) diagnosed bipolar disorder is an exclusion 
criterion for the present study.  Nonetheless, comprehensive clinical studies quantifying the risk 
more precisely are clearly lacking.  For the present study, participants will be closely monitored 
throughout the study to assess for any such effects.  Participants will also be specifically instructed 
to tell the research staff if they notice an unwanted change in mood. 
 
D.  Protection of the Subject (include: D.1. measures to minimize potential risks; D.2 measures to 
ensure confidentiality; D.3. data safety monitoring plan) 
  

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Participants will be reminded that they may stop participating in the study at any time for any 
reason with no adverse consequences to health or future relationships with Butler Hospital or Brown 
University. Participants will be encouraged to take breaks when needed. They will be reminded that 
they may refuse to answer any questions on the study questionnaires and they may stop the tDCS 
treatment session at any time.   
 
D.1. Measures to Minimize Potential Risks 
 
D.1A Management of Risk due to due to Clinical and Cognitive Assessment Administration 
At least one of the MD investigators will be available to address any mental health concerns 
and assist in appropriate referrals as needed. As noted above participants may refuse to answer any 
questions and take breaks as needed. 
D.1B Management of Risks due to tDCS. 
Direct Current (DC) polarization has been applied unilaterally to the primary motor and dorsal 
prefrontal areas in many studies over the past decade (Wassermann, 2008) with no reports of 
adverse effects attributable to effects on the central nervous system. The proposed stimulation 
intensity in this study is similar to the stimulation intensity used in previous protocols as also 
performed at the NIH (and for which the risk determination from the FDA was requested). No 
adverse side-effects have been reported in these previous studies with the proposed stimulation 
settings. The proposed intensity level is therefore at the level at which we will expect to find effects 
of tDCS on our behavioral output measure, but without causing adverse side-effects. In a study 
measuring thermal effects of tDCS using a MRI-derived finite element human head model 
conventional rectangular-pad (7x5 cm2) electrodes were found not to increase tissue temperature 
using a bio-heat model (Datta et al., 2009). In safety studies conducted at City College of New York 
(CCNY) and during usage at the National Institutes of Health (NIH), sets of these electrodes did not 
cause skin problems more serious than tingling and transient redness when applied to the skin of the 
arm with current densities up to 2.56 mA/cm2 and durations of up to 22 minutes (Dr. Biksom, 
personal communication). It was also found that cathodal current produced the most skin irritation. 
However cathodal stimulation will be of crucial importance to our study design as we hypothesize 
that our target brain areas may be overactive, and hence require suppression.  During cathodal 
stimulation we will take extra precautions that consist of instructing the participants to advise the 
research staff of any discomfort during testing, inspection of stimulation sites as needed and 
immediate discontinuing stimulation if discomfort occurs. 
The tDCS device that will deliver the direct current is adjustable in both intensity as well as 
duration of stimulation. In addition, the device will be 9V battery-driven to function as a constant 
current stimulator with a maximum output in the milliamps range with absence of the risk of sudden 
large intensities of electrical current that could occur with an electrical driven device. 
Prolonged passage of direct current across metallic electrode (where electrons from the 
stimulator are converted to ions carried through the body) can produce undesired electrochemical 
products such as pH changes. The sponge pocket will act to physically separate, and thus buffer, 
the skin from electrochemical changes. The normal saline used on the sponges assists in preventing 
burns.  In addition, electrodes/sponges will not be placed over cuts, or skin lesions such as vascular 
moles and angiomas that might have greater conductance than the surrounding skin. One set of 

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sponges will be used throughout the study for each participant.  Electrodes will be held in place by 
using special head bands made of flexible rubber. 
All participants will be carefully screened prior to tDCS for contraindications to tDCS (see 
exclusion criteria). At least one PI will be available on an immediate basis for all study treatment 
sessions. 
tDCS will be administered by the tDCS Operator - a trained and qualified individual 
supervised by the principal investigators to deliver, or assist in delivery of, tDCS. Training includes 
the knowledge of safety considerations and precautions associated with tDCS. 
Participants will be closely monitored throughout the study to assess for any adverse effects 
on cognition or mood.  Participants will also be specifically instructed to tell the research staff if they 
notice an unwanted change in mood during the course of treatment. 
 
The tDCS operator will: 
a) Assess the participants’ scalp skin where the electrodes will be placed to assure it is 
intact, free of lesions, cuts or exclusionary skin disorders. 
b) Prepare and position the electrodes and tDCS device on the participant for accurate brain 
stimulation according to the protocol prior to initiation of stimulation. 
c) Operate the hardware associated with the tDCS device to assure the level of current and  
amount of time is accurate per protocol. 
d) Administer the tDCS, at the parameters established by the tDCS Attending Physician as 
per identified in this protocol. 
e) Assess the participants mental status and general clinical condition before and after tDCS 
to assure the safety of the participant to have tDCS and the safety of the participant to return 
home. 
f) Monitor the participant during the tDCS session to assess for potential occurrence of 
adverse events. 
g) Make routine adjustments to the placement of the device as required and consistent with 
product labeling (e.g., to ensure contact between participant’s head and electrode) during the 
tDCS session. The tDCS Operator may not independently make any revision to pre-
determined stimulation dose or electrode position parameters prescribed by the study 
protocol. 
h) Determine if tDCS should be interrupted or terminated (e.g., participants express 
increasing discomfort to their skin under the electrodes; participants show signs of discomfort 
or other stress; participant wants to discontinue study procedures). 
i) Take action in accordance with established Butler Hospital regulations in case of adverse  
events, for example: he/she will seek immediate medical attention for the participant if 
necessary; if there is any doubt about the mental or physical status of a participant after 
testing he/she will consult with the available study physician. He/she will document and 
report all adverse events (e.g. skin lesion or significant skin discomfort) to the principal 
investigators. A study physician will evaluate the participant and make a recommendation for 
immediate or follow-up care if required. Telephone or in-person follow-up will be arranged as 
needed. Any participant judged on clinical grounds to have suffered adverse effects will thus 
be evaluated and treated as necessary and withdrawn from the study. 

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j) When not in use, assure the tDCS machine, electrodes, sponges, conductive gel, alcohol 
prep pads and normal saline are maintained in the secure location as assigned to Dr. 
Greenberg in a lockable room. 
 
The experimenter will closely observe participants for signs of skin burns, discomfort, or 
other stress. Participants will have the option of discontinuing the study at any time and will be 
explicitly instructed to inform the experimenters immediately if they experience any discomfort. The 
experimenter will inform the supervising physician about any participant who has significant skin 
discomfort or a skin lesion after current delivery. If there is any doubt about the mental or physical 
status of an individual after testing, the principal investigators (or other supervising physician) will 
evaluate the participants and make a recommendation for follow-up care if that is required. 
Telephone or in-person follow-up will be arranged as needed.  Any participant judged on clinical 
grounds to have been injured as a direct result of participation in this research will be offered 
emergency medical treatment by Butler Hospital paid for by research funds, except for costs that are 
covered by your insurance or governmental programs, and withdrawn from the study. 
 
D.2 Management of Risks to Confidentiality 
 
Strict standards of confidentiality will be maintained. Precautions will be taken to prevent 
disclosure of information to unauthorized parties. 
All paper records, forms and data will be stored in secure files to which only members of the 
investigative team will have access. Computer records will be protected by standard measures that 
limit access of the data to designated trained research project personnel. 
This research data will include participant information that may be of a sensitive nature. All 
patient data will be stored in locked files in lockable offices.  Computers with subject data will be 
password protected and encrypted to ensure confidentiality of patient records. 
  
D.3. Data Safety Monitoring Plan 
 
Specific aspects of the data safety monitoring plan are: (1) Data sheets will be stored in one 
of the Principal Investigators’ locked files in a locked office; (2) Data will be entered in coded form; 
(3) Data will be stored in computer files protected from unauthorized access by passwords; (4) 
Information that might potentially allow an individual participant to be identified will not be allowed in 
any publications, or reports sent to individuals outside the study; and (5) All employees who are to 
handle data will be certified in Good Clinical Practice and Human Subjects Protection Training in 
confidentiality policies and procedures. 
Only information relevant to the protocol will be recorded. Personal Health Information (PHI) 
collected as part of the study protocol is shared only with the collaborative site on the project and is 
shared in de-identified form only. 
 
E.  Potential Benefits 
 
This study is designed to measure the potential benefits of tDCS for treating pain. This is an 
investigational study and therefore we cannot guarantee that patients will indeed experience a 
reduction in symptoms of their chronic low back pain. Participating in this study, however, may serve 

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to benefit advances in understanding chronic pain, potentially leading to future improvement in 
treatments. 
 
F.  Risk-Benefit Ratio 
 
Furthering knowledge regarding the brain mechanisms underlying the affective component of 
the chronic pain experience may provide significant benefit in developing alternative effective 
treatments for chronic pain. The approach taken in this research may provide beneficial treatment for 
this debilitating condition. Additionally, transcranial direct current stimulation, or tDCS, is classified 
by the FDA as a minimal risk technique. Therefore, we believe that the potential benefits of this 
study greatly outweigh the potential risks that may occur as a result of participating in this study. 
 
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Souza, M. Riberto, S. D. Freedman, M. A. Nitsche, and A. Pascual-Leone. A sham-controlled, 
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individuals. Neurology, 64(5), 872-875, 2005. 
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stimulation concerning healthy subjects and patients. Brain research bulletin, 72(4), 208-214, 
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MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health 
Questionnaire. JAMA : the journal of the American Medical Association, 282(18):1737–1744, 
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E. Wassermann. Direct current brain polarization. In E. Wassermann, C. Epstein, S. Lisanaby, T. 
Paus, V. Walsh, and U. Ziemann, editors, The Oxford Handbook of Transcranial Stimulation, 
pages 57–61. Oxford University Press, Oxford, 2008. 
 
5) STUDY RATIONALE: (complete for studies where only waiver is requested): 
  
 
6) CRITERIA FOR WAIVER OF AUTHORIZATION FOR USE OF PROTECTED HEALTH 
INFORMATION (PHI) 
  
6A. Does the requested use of PHI involve more than minimal risk to privacy? 
☐   YES   [if " YES," project is not eligible for PHI Waiver]   
☑    NO     [if "NO," address 1-3 below] 
  
      Plan to Protect Patient Identifiers from Improper Use and Disclosure: 

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a. Any on site electronic file containing PHI is password protected. 
b. All subjects will be assigned a number to which they are referred so that only their 
number is associated with their data file. 
c. All paper files containing subject responses are kept under lock and key. 
d. Patients will not be personally identified in any publications or reports of this research. 
e. Only trained research staff will have access to patient charts and data. 
f. 
Only information relevant to the protocol will be recorded. 
g. The master list and copy containing subject names and study numbers will be 
password-protected on computer equipment in a locked office. 
  
      Plan to Destroy Identifiers or Justification for Retaining Identifiers: 
  Identifiers will be retained so that they may be used for data analysis in this protocol and 
future  
  investigations. 
 
      Assurances that the PHI will not be Re-used or Disclosed: 
PHI collected as part of the study protocol is shared only with the collaborative site on the 
project and is shared in de-identified form only. 
 
6B. Could the research be practicably conducted without a waiver? 
☐ YES ☑ NO 
 
6C. Could the research be practicably conducted without access to and use of the PHI? 
☐ YES ☑ NO 
 
 6D. PHI is only needed for activities preparatory to research 
☐YES ☑ NO 
 
7) DESCRIPTION OF NEEDED PHI 
Name, date of birth, gender, education level, ethnicity, telephone numbers, address, address, clinical 
diagnoses, treatment history, medical history, clinical rating scores, cognitive test results. 
 
 
 

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8)    ADVERTISEMENTS 
Transcranial Direct Current Stimulation (tDCS)  
for Chronic Low Back Pain Research Study 
We are studying a new device for treating chronic low back pain (CLBP) and are enrolling adults age 
18+ in a clinical research trial. If you have been diagnosed with CLBP by a physician for at least 6 
months, have tried at least one physician-recommended pain medicine, and have no current 
diagnosis of substance dependence, you may be eligible to participate.  We will use a method for 
stimulating the brain, called transcranial Direct Current Stimulation (tDCS), to attempt to change the 
way you feel about your pain. 
 
The tDCS device uses a small electric current applied through removable electrodes placed on your 
scalp while awake.  We will not need to shave any hair.  Study participants will be randomly 
assigned to receive active or placebo tDCS, while following their regular health routine. 
● 
The study involves 10 visits to the Butler Hospital campus over a 2-week period with a 
follow-up phone call approximately six (6) weeks later. 
● 
Compensation up to $60 is available for eligible study participants. 
 
Eligibility 
● 
Adults (18+) with a history of chronic low back pain made as a clinical diagnosis 
● 
Any pre-existing pain medication must be stable for at least one month 
● 
No lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic  
● 
conditions 
● 
No current cancer, infection, or inflammatory arthritis 
● 
No metal in your head or holes in your skull from trauma or surgery 
● 
No implanted pacemakers, pumps, or other electronic hardware 
 
If you are interested in learning more about Transcranial Direct Current Stimulation (tDCS) for 
Chronic Low Back Pain Research Study, please call (401) 455-6610 or go to 
www.butler.org/XXXX. 
 
Please provide your name, telephone number, and a good time to reach you.  Please do not include 
any other information.  When you are done, press submit. A member of the research team will 
contact you soon.