Treating Self Injurious Behavior: A Novel Brain Stimulation Approach
Phase: NA
Conditions: Self-Injurious Behavior, Self Harm, Self-injury, Self-inflicted Injury, Self Injurious Behavior Without Suicidal Intent, Non-Suicidal Self Injury, Non Suicidal Self Inflicted Injury, Cutting, Depression, Bipolar Disorder, Borderline Personality Disorder
Sponsor: New York State Psychiatric Institute

Cover Sheet 
 
Protocol Name: Trea.ng Self Injurious Behavior: A Novel Brain S.mula.on Approach 
 
Protocol NCT Number: NCT04244786 
 
Date: 7/29/22 

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Protocol Title:
Treating Self Injurious Behavior: A Novel 
Brain Stimulation Approach
Protocol Number:
7170
First Approval:
01/21/2016
Expiration Date:
08/02/2022
Version Date:
07/29/2022
Research Area:  
Molecular Imaging & Neuropathology
Division:  
Molecular Imaging and Neuropathology
Contact Principal Investigator:
Jeffrey Miller, MD
Email: jm2233@columbia.edu
Telephone: 646-774-7613
Co-Investigator(s):
Barbara Stanley, PHD
Daniel Javitt, MD, PHD
Ashley Yttredahl
Research Chief:
J John Mann, MD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
I am submitting an annual continuation without modifications 
Department & Unaffiliated Personnel
Department
What Department does the PI belong to?
MIND/Psychiatry
Within the department, what Center or group are you affiliated with, if any? 
N/A
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 

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State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
Richard Carson, Ph.D., Yale University, Co-Investigator
Marc Potenza, MD, PhD - Yale University, Co-Investigator/ Study Physician
Jiansong Xu, MD, PhD – Yale University, Co-Investigator 

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Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   Internet-based Data Collection or Transmission
   MRI
   Use of Investigational Drug or Device
Population
Indicate which of the following populations will be included in this research
   Adults
   Adults over 50
   Employees or Students
Research Support/Funding
Will an existing internal account be used to support the project?
No
Is the project externally funded or is external funding planned?
Yes
Select the number of external sources of funding that will be applicable to this study
Funding Source #1
Is the PI of the grant/contract the same as the PI of the IRB protocol? 
Yes
Select one of the following
The grant/contract is currently funded
Source of Funding
Foundation
Sponsor
Citronberg Fellowship

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Select one of the following
Single Site
Business Office
RFMH
Does the grant/contract involve a subcontract?
No
Study Location
Indicate if the research is/will be conducted at any of the following
NYSPI
This protocol describes research conducted by the PI at other facilities/locations
No
Lay Summary of Proposed Research
Lay Summary of Proposed Research
The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current
stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). NSSI is the deliberate
attempt to harm oneself, most often through cutting or burning, without suicidal intent. NSSI is a
maladaptive emotion-regulation strategy often triggered by negative emotions, especially those involving
feelings of rejection. tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation
that delivers a low current to a specific area of the brain via electrodes. Several studies have demonstrated
its effectiveness in treating an array of conditions, depending on electrode placement, including depression
and chronic pain. tDCS may also facilitate adaptive emotion regulation; researchers have also successfully
used tDCS to reduce negative emotions and aggressive responses to social rejection. We therefore seek to
explore tDCS as a potential treatment for NSSI. This pilot feasibility study seeks 1) to examine how tDCS is
tolerated in a sample of individuals who engage in frequent NSSI; 2) to gather pilot data regarding changes
in neural responses to social rejection after a series of tDCS sessions in this clinical population of
individuals who engage in NSSI; 3) to gather pilot data on the effects of tDCS on NSSI behaviors and urges.
A sample of up to 10 volunteers will pilot the social feedback task during fMRI to assess its feasibility
before beginning fMRI procedures in our patient sample. This task will involve participants playing a virtual
ball-tossing game with two cartoon characters over the computer. We seek to recruit a sample of 22
individuals who engage in frequent NSSI to complete all study procedures, including neuroimaging.
Individuals will be randomized to receive active- or sham-tDCS for two twenty-minute applications on each
of six alternating days over approximately two weeks. tDCS delivery using a remotely-supervised treatment
protocol will minimize the burden of study visits and allow patients to continue participating in research
from the comfort of their homes when in-person procedures are not possible. During tDCS, participants will
listen to an audio file with different sounds and a voice instructing them to switch their attention between
the different sounds. The fMRI task will be performed at baseline and again after the completion of 12
sessions of tDCS. Subjects’ NSSI and urges to engage in NSSI will be recorded for three weeks in real-time,
using an iPod- based system that reminds subjects to stop at certain times during the day to record their

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thoughts, feelings, and behaviors. This will allow measurement of NSSI urges and behaviors for one week 
before, one week during, and one week after the tDCS intervention. The long-term goal of this study is to 
identify a novel form of treatment for NSSI and to better understand NSSI pathophysiology.
 
A sample of 24 patients who engage in NSSI will also be recruited to evaluate the feasibility of at-home 
self-administration of tDCS. tDCS delivery using a remotely-supervised treatment protocol will minimize 
the burden of study visits and allow patients to continue participating in research from the comfort of their 
homes when in-person procedures are not possible. These participants will undergo similar study procedures 
as described above for patients with NSSI, except for the MRI scan, in order to explore aims 1 and 3 above 
in a remote setting. Those in the remote arm of the study will complete an additional week of tDCS 
sessions, totaling 12 sessions over 6 days. We will continue to offer three months of treatment visits with a 
study psychiatrist at no-cost at the conclusion of study procedures, which will be provided via telemedicine.
Background, Significance and Rationale
Background, Significance and Rationale
Non-suicidal self-injury (NSSI), “the deliberate, self-inflicted destruction of body tissue without suicidal 
intent” ((Nock & Favazza, 2009), http://www.itriples.org/isss-aboutself-i.html), is a serious psychiatric 
problem (Briere & Gil, 1998; E. D. Klonsky, 2011) that is observed across a broad array of psychiatric and 
developmental conditions, including major depression, borderline personality disorder, intellectual 
disabilities, autism, Prader-Willi Syndrome, and Lesch-Nyhan Syndrome (Symons et al., 2001). NSSI is one 
of the most predictive risk factors for suicide attempts (Andover & Gibb, 2010; Favaro et al., 2008; E. 
David Klonsky, May, & Glenn, 2013; Lloyd-Richardson, Perrine, Dierker, & Kelley, 2007; Nock, Joiner, 
Gordon, Lloyd-Richardson, & Prinstein, 2006), and has a high prevalence, with estimates suggesting that 
about 21% of adult psychiatric inpatients (Briere & Gil, 1998) and 30-40% of adolescent inpatients have a 
history of NSSI (Darche, 1990). As the pathophysiology of NSSI is not well understood, clinicians have 
limited ability to predict which treatments will be most effective for specific individuals suffering from 
NSSI, making cases frequently persistent and treatment-refractory (Perry et al., 2009). Novel studies based 
on possible underlying mechanisms for NSSI are greatly needed to reduce the morbidity and mortality 
associated with this behavioral phenomenon. 
 
NSSI is a maladaptive emotion regulation strategy. People who engage in NSSI are more likely to have high 
sensitivity to social rejection and perceived social rejection can trigger the urge to engage in NSSI, (Nock, 
Prinstein, & Sterba, 2009). Studies using fMRI have shown that patients who frequently engage in NSSI 
also have heightened BOLD responses to social rejection in regions associated with subjective distress, such 
as the anterior insula (AI) and dorsal anterior cingulate cortex (dACC) (Brown et al., 2017; Groschwitz, 
Plener, Groen, Bonenberger, & Abler, 2016). This sample also exhibited abnormal responses in the 
ventrolateral prefrontal cortex, a key region for inhibitory control over emotions and response tendencies. 
The vlPFC has been shown to exert top-down influence on the amygdala and nucleus accumbens (Berkman, 
Kahn, & Merchant, 2014; Berkman & Lieberman, 2009; Cohen, Berkman, & Lieberman, 2013; Wager, 
Davidson, Hughes, Lindquist, & Ochsner, 2008; Wagner & Heatherton, 2013), subcortical regions involved 
in emotion-generation, during emotion regulation tasks such as reappraisal. During social rejection, activity 

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in the vlPFC negatively correlates with both subjective reports of distress as well as BOLD activity in the AI 
and dACC (Eisenberger, Lieberman, & Williams, 2003; Eisenberger, Way, Taylor, Welch, & Lieberman, 
2007; Kawamoto et al., 2012; Onoda et al., 2010), demonstrating its importance in shaping emotional 
responses to social stimuli.  Collectively, these data suggest that the vlPFC may be a promising target for 
NSSI treatment. 
 
Novel brain stimulation approaches may modulate vlPFC activity and, in so doing, could potentially exert 
therapeutic effects on NSSI. Transcranial direct current stimulation (tDCS) is an inexpensive, portable, non-
invasive form of brain stimulation that has demonstrated efficacy in major depressive disorder (Brunoni et 
al., 2013), cognitive difficulties (Hoy, Arnold, Emonson, Daskalakis, & Fitzgerald, 2014), and chronic pain 
(Villamar et al., 2013). By modulating the activity of neural regions involved in emotion regulation, tDCS 
may facilitate adaptive emotional responses to the environment. Recent studies have shown reductions in 
emotional distress and aggression following social rejection in healthy participants by stimulating the right 
ventrolateral prefrontal cortex (vlPFC) using tDCS (Riva, Lauro, DeWall, & Bushman, 2012; Riva, Lauro, 
DeWall, Chester, & Bushman, 2014; Riva, Lauro, Vergallito, DeWall, & Bushman, 2015). In her doctoral 
work, Dr. Yttredahl found reductions in rumination following social rejection due to vlPFC tDCS were 
directly related to trait emotion regulation abilities whereby participants with poorer regulation benefitted 
the most (Yttredahl, 2019).
The primary aim of this study is to examine the tolerability and effectiveness of tDCS in treating NSSI and 
urges to engage in NSSI. For this experiment in which we are examining the effects of anodal vLPFC tDCS 
on NSSI behavior and the neural correlates of social rejection assessed by fMRI, we plan to enroll up to 50 
individuals who engage in frequent NSSI to obtain a sample of 23 subjects who complete the study 
procedures. Participants will be randomized to receive active anodal vs. sham tDCS to right vlPFC for two 
twenty-minute applications on each of six alternating days over approximately two weeks. During the 
stimulation, participant behavior will be standardized by having all participants engage in the same 
Attention Training Technique administered over headphones. NSSI behaviors and urges will be recorded for 
three weeks using Ecological Momentary Assessment (EMA), a novel procedure that minimizes recall bias 
by capturing the thoughts, feelings, and behaviors of subjects in real time. This will allow measurement of 
NSSI urges and behaviors for the weeks before, during, and after the tDCS intervention. Our first goal in 
this study is to characterize tolerability and acceptability of this intervention in this population. Secondly, 
we wish to identify changes in BOLD responses to social rejection from pre- to post-tDCS using fMRI. We 
hypothesize that activity in the AI, dACC, and amygdala during rejection will be attenuated by tDCS. 
Lastly, it is hypothesized that tDCS directed to the right vlPFC will lead to reductions in both NSSI and in 
urges to engage in NSSI. This pilot work may pave the way for larger controlled trials to examine 
differential target engagement and clinical efficacy between active and sham conditions.
In order to continue to conduct research with patients who engage in NSSI, given the current state-instituted 
shutdown of in-person research activities, we are adding a remote-tDCS arm to our study. Remotely 
supervised, at-home tDCS has been gaining traction in clinical research in order to broaden the reach of 
clinical trials and reduce burdensome travel for patients receiving multiple tDCS sessions (Charvet et al., 
2015; Cucca et al., 2019). Specialized tDCS devices, such as the Mini-CT (Soterix, Inc) used in this study, 
have been developed to allow researchers to strictly control the dosing and timing of self-administered tDCS 
in the clinical setting (Charvet et al., 2015; Cucca et al., 2019; Shaw et al., 2017). These devices, combined 
with validated protocols, enable researchers and clinicians to provide safe, reliable, reproducible tDCS 

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stimulation to patients outside of the clinic (Charvet et al., 2015, 2020). Patients who enroll in our study are 
monitored regularly by a psychiatrist who provides open treatment for three months at the conclusion of 
tDCS procedures (and sooner in the event of clinical worsening). By creating a remote tDCS arm, we will 
be able to continue to enroll participants in research procedures, offer treatment following research 
procedures, and add valuable data to the literature on the feasibility and efficacy of at-home remotely-
supervised tDCS in this clinical population. This same equipment and procedure will be used in the 
neuroimaging arm of the study as well, so that participants who feel comfortable enough to receive MRI 
scanning at NYSPI can still receive all other assessments and tDCS remotely.
 
Heart rate variability: The autonomic nervous system (ANS) plays an intrinsic role in the coordinated brain-
body activity that gives rise to subjective emotional states and enables regulation of ongoing emotional 
experience. Increased heart rate, which may be parasympathetically and/or sympathetically driven, 
contributes somatic cues necessary to discern emotional feeling states and mount an appropriate response 
(Levenson, 2003). Cardiac innervation from the parasympathetic branch of the ANS enables rapid and 
flexible modulation of the heart rhythm, allowing swift adjustment to complex emotional demands (Thayer 
& Lane, 2000). By adding acquisition of ECG data concurrent with the fMRI social feedback task, we will 
be able to analyze these real-time sympathetic and parasympathetic responses to social rejection. Concurrent 
autonomic measurement may also aid in interpreting neural responses to task-relevant stimuli. These data 
will complement our investigation of the effectiveness of tDCS in facilitating adaptive emotion regulation in 
individuals with NSSI. 
Specific Aims and Hypotheses
Specific Aims and Hypotheses
Aims/Hypotheses 1 through 3 pertain to the sample of patients with NSSI. Aim 4 pertains only to the non-
clinical sample who will pilot our social feedback task. Aim 5 pertains to the remotely-supervised no-
contact arm of the study.
1. Evaluate the tolerability and acceptability of a tDCS intervention in a sample of individuals engaging 
in frequent NSSI. We hypothesize that 6 treatments of tDCS (two times per day for three days over 
right vlPFC) will be well-tolerated by study participants who engage in frequent NSSI. 
2. Characterize changes in BOLD responses to social rejection from pre- to post-tDCS sessions in the 
active tDCS group compared to the sham tDCS group using fMRI and a social exclusion task called 
Cyberball. Hypothesis: BOLD activity in the dorsal anterior cingulate cortex, the anterior insula, the 
amygdala, and the medial PFC/rostral ACC will scale with different percentages of exclusion in 
Cyberball. Furthermore, there will be a significant interaction effect whereby participants in the 
sham stimulation group will show greater changes in these three regions during scan 2 compared 
with those in the active group. 
3. Gather pilot data on the effectiveness of tDCS in treating NSSI and the urge to engage in NSSI in 
patients currently suffering from NSSI on a regular basis. Hypothesis: tDCS directed to the right 
ventrolateral prefrontal cortex will lead to greater reductions in both NSSI and in urges to engage in 

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NSSI, as assessed by self-report measures as well as real-time monitoring using ecological 
momentary assessment, than sham tDCS. 
4. Assess feasibility of the behavioral and neural responses to a social feedback task in a non-clinical 
sample.
5. Assess the feasibility of using remotely-supervised tDCS self-administration in a sample of patients 
who engage in NSSI.
Description of Subject Population
Sample #1
Specify subject population
Patients with NSSI receiving M1 tDCS and PET (no longer recruiting)
Number of completers required to accomplish study aims
3
Projected number of subjects who will be enrolled to obtain required number of completers
10
Age range of subject population
18-60
Sample #2
Specify subject population
Patients with NSSI receiving M1 tDCS without neuroimaging (no longer recruiting)
Number of completers required to accomplish study aims
10
Projected number of subjects who will be enrolled to obtain required number of completers
20
Age range of subject population
18-60
Sample #3
Specify subject population
Sample of healthy volunteers for fMRI pilot
Number of completers required to accomplish study aims
10
Projected number of subjects who will be enrolled to obtain required number of completers
10
Age range of subject population

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18 - 60
Sample #4
Specify subject population
Patients with NSSI receiving VLPFC tDCS and fMRI
Number of completers required to accomplish study aims
22
Projected number of subjects who will be enrolled to obtain required number of completers
50
Age range of subject population
18-60
Sample #5
Specify subject population
Remotely-Supervised Patients with NSSI
Number of completers required to accomplish study aims
24
Projected number of subjects who will be enrolled to obtain required number of completers
50
Age range of subject population
18-60
Gender, Racial and Ethnic Breakdown
Patients with NSSI:
a. Gender: Based on previous clinical trials and biological studies in our research division recruiting 
individuals with self-injury, 60% of participants were female. 
b. Ethnicity: No ethnic/racial group is excluded. Since subjects will be recruited by advertisement in the 
same fashion as we have done for previous studies, we expect that the sample will be similar to those who 
have responded to our advertisements in the past. Based on previous clinical trials and biological studies in 
our research division recruiting individuals with self-injury, we anticipate that our study population will be 
approximately 15% Hispanic, 85% non-Hispanic; 75% white, 22% black, and 3% Asian. 
Description of subject population
Patients with NSSI undergoing tDCS and fMRI:
Our sample will be defined by a symptom/pattern of behavior, and not by a DSM-V diagnosis. Specifically, 
we seek to recruit individuals engaging in frequent NSSI, because that is the symptom that we will attempt 
to target with this treatment. We aim to recruit 22 subjects who complete all study procedures. Based on 
recent brain imaging studies in our division, we estimate that we will need to enroll 50 subjects to achieve 
this number of completers, due to subject ineligibility, subject withdrawal prior to study completion, and 
failure to attend appointments.
 
Sample of healthy volunteers for fMRI pilot:

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We will recruit up to 10 healthy volunteers currently or previously enrolled in IRB #6786 or 7653 or 7172 
to complete the social feedback task twice during fMRI. 
 
Patients with NSSI undergoing remote tDCS:
Our sample will be defined by a symptom/pattern of behavior, and not by a DSM-V diagnosis. Specifically, 
we seek to recruit individuals engaging in frequent NSSI, because that is the symptom that we will attempt 
to target with this treatment. We aim to recruit 24 subjects who complete all study procedures. Based on 
recent brain imaging studies in our division, we estimate that we will need to enroll up to 50 subjects to 
achieve this number of completers, due to subject ineligibility, subject withdrawal prior to study completion, 
and failure to attend virtual appointments.  
Recruitment Procedures
Describe settings where recruitment will occur
Sample of patients with NSSI:
Participants may be recruited from the New York Presbyterian Hospital emergency room, referrals for 
inpatient and outpatient treatments from the community, a large network of referring doctors, and the 
extensive outpatient depression clinics at NYSPI (e.g., Depression Evaluation Service and the Late Life 
Depression Center).  Participants will also be recruited via advertisements. Printed advertisements will be 
posted and distributed around the medical center and in surrounding areas and may be given to affiliated 
clinicians. Online advertisement is described below. 
 
Sample of healthy volunteers for fMRI pilot: 
Healthy volunteers will be previously or currently enrolled in IRB #4185 or 6786 or 7653 or 7172 and will 
be contacted by phone.  
How and by whom will subjects be approached and/or recruited? 
Sample of patients with NSSI:
Clinical inpatients and emergency room patients will not be approached by research staff until clinical staff 
has ascertained that they are willing to discuss possible research participation. Participants will be recruited 
through printed as well as online advertisements. Subjects who have completed other protocols in our 
division may also be contacted and asked about study participation. Providers in the community may be 
contacted by email to refer patients who are interested and potentially eligible.
 
Sample of healthy volunteers for fMRI pilot:
Only participants who checked the box agreeing to be contacted for other studies on a consent form for IRB 
#4815 or 6786 or 7653 or 7172 will be contacted and offered the option of participating in these study 
procedures. Participants will be contacted by telephone by our research coordinator, Dr. Miller, or Dr. 
Yttredahl.

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How will the study be advertised/publicized? 
Sample of patients with NSSI:
Online advertisements will be placed on websites that may include Craigslist, in sections including 
volunteers, gigs, and jobs, Google Ads, Facebook, Research Match, RecruitMe, and others including our 
own IRB-approved website: https://tdcsresearch.wordpress.com . We will advertise this study to Columbia-
affiliated clinicians on the Columbia University PsychoPharmacology (CUPP) list-serve and will email local 
providers. The Google Ad includes the following link to a description of the study on the Columbia 
Recruitme Website:
https://recruit.cumc.columbia.edu/clinical_trial/1324 
where participants can learn more about the study and contact us if possibly interested in participating.
 
We would like permission to change contact information (name, phone #s) on internet-based advertisements 
(craigslist ads, CUPP posting, etc...) as needed. Any individuals listed as a contact for recruitment will have 
previously completed CITI training.
Do you have ads/recruitment material requiring review at this time? 
No
Does this study involve a clinical trial?
No
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
Yes
Describe concurrent research involvement
Sample of patients with NSSI:
Participants will be screened through our division’s screening protocol: 
IRB # 6879R: Molecular Imaging and Neuropathology Clinic Studies Initial Evaluation (formerly #5880R)
Participants will co-enroll in our division’s umbrella protocol:
IRB #4815: Biological and neurocognitive measures for genetic studies of psychiatric populations (PI: 
Maria A. Oquendo, M.D.)
Participants who previously enrolled in studies who may meet study eligibility criteria for the current study 
may be re-contacted to ask about their interest in current study participation. This includes studies in which 
participants have already given written consent to be re-contacted about future studies, including:
IRB #6777R: Treating of Suicidal Behavior and Self-Mutilation in BPD: Predictors of Change (PI: Barbara 
Stanley, Ph.D.)
IRB # 5792R: Prospective Study of Predictors of Suicidal Behavior in Borderline Personality Disorder 

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(BPD) - Biological Measures (formerly # 4728)
If we seek to re-contact subjects from protocols that do not include consent for re-contacting subjects, we 
will submit a ward-off letter to the IRB for approval. 
 
Sample of healthy volunteers for fMRI pilot:
Participants who previously enrolled in IRB #4815 or 6786 or 7653 or 7172 as a healthy volunteer may be 
re-contacted to ask about their interest in current study participation, if they have already given written 
consent to be re-contacted about future studies.
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Neuroimaging participants
Create or insert table to describe the inclusion criteria and methods to ascertain them
 Neuroimaging participants with NSSI: Inclusion Criteria Method of 
Ascertainment 
1. Age 18-60
Remote 
interview
2.
Frequent current NSSI (including cutting in which the 
skin is broken; self-hitting in which there is bruising; or 
burning in which there is evidence of a burn. Will not 
enroll if skin-picking or scratching is the only form of 
self-injury): has engaged in ≥2 episodes of NSSI in the 
two months prior to enrollment
Remote Self 
Injurious 
Thoughts and 
Behaviors 
(SITBI) scale 
and remote 
clinical 
interview
3. Capacity to provide informed consent
Remote clinical 
interview
4. If carries a diagnosis of bipolar I or II disorder, taking or 
willing to begin a therapeutic dose of a mood stabilizer*
Remote SCID, 
remote clinical 
interview, 
therapeutic 
blood levels if 
applicable
5. Normal hearing
Remote 
interview
6.
Physical capacity (e.g., manual dexterity) to set-up and 
self-administer tDCS
Remote 
interview

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* If not currently taking a mood stabilizer, the participant will have the option of beginning mood stabilizer 
with a psychiatrist on our team. We would perform any necessary blood testing to screen for 
appropriateness of mood stabilizer treatment and to monitor blood levels. We would provide psychiatrist 
visits and any necessary blood testing, but would not cover the costs of mood stabilizer medication. If 
participants continue to meet all other eligibility criteria upon achieving a therapeutic dose of mood 
stabilizer, we would proceed with research participation.  If they do not, we would forego research 
procedures and offer 3 months of open treatment.
Create or insert table to describe the exclusion criteria and methods to ascertain them
 
Neuroimaging participants with NSSI: Exclusion Criteria
Method of 
Ascertainmen
t
1. Unstable medical conditions based on medical history or 
medical assessment
Medical 
history (by a 
physician), 
medical 
assessment as 
conducted in 
IRB #4815 
2. Current psychotic disorder, mania, hypomania, 
intellectual disability
Remote 
psychiatric 
interview and 
SCID 
3. Dermatologic condition resulting in non-intact skin on 
the scalp
Medical 
history
4. Significant suicidal ideation with a plan and intent that 
cannot be managed safely as an outpatient
Remote C-
SSRS, remote 
clinical 
interview 
5. Pregnancy, currently lactating, or planning to conceive 
during the course of study participation* 
Urine HCG 
on days of 
MRI scans 
prior to 
scanning
6.
A neurological disease or prior head trauma with 
evidence of cognitive impairment. Subjects who endorse 
a history of prior head trauma and score ≥ 1.5 standard 
deviations below the mean on the Trailmaking A&B will 
be excluded from study participation.
Remote 
clinical 
interview and 
medical 
history, 
Trailmaking 
A & B as 

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needed.
7. Current alcohol or substance use disorder that is severe 
according to DSM-5 criteria
Remote SCID 
and clinical 
interview
8.
Individuals who initiated or increased the dose of 
concurrent psychiatric medications (including 
antidepressants, anxiolytics, antipsychotic medications, 
and mood stabilizers) within two weeks prior to 
enrollment
Remote 
clinical 
interview and 
medical 
history
9. Individuals who initiated psychotherapy within two 
weeks prior to enrollment
Remote 
clinical 
interview
10. Current seizure disorder
Remote 
clinical 
interview and 
medical 
history 
11. Use of anticonvulsant medications that target the GABA 
system (e.g., gabapentin)
Remote 
clinical 
interview and 
medical 
history
12.
Individuals currently using benzodiazepines who are 
unable or unwilling to refrain from the use of 
benzodiazepine medications for at least 72 hours before 
the first tDCS session and throughout the duration of the 
2-week tDCS intervention**
Remote 
clinical 
interview and 
medical 
history
13.
Metal implants or paramagnetic objects contained within 
the body (including heart pacemaker, shrapnel, or 
surgical prostheses) which may present a risk to the 
subject or interfere with the MRI scan, according to the 
guidelines set forth in the following reference book 
commonly used by neuroradiologists: “Guide to MR 
procedures and metallic objects,” F.G. Shellock, 
Lippincott Williams and Wilkins NY 2001. Additionally, 
transdermal patches will be removed during the MR 
study at the discretion of the investigator.
Remote 
clinical 
interview, 
MRI safety 
screening 
forms
14. Claustrophobia significant enough to interfere with MRI 
scanning
Remote 
clinical 
interview and 
medical 
history
15. Weight that exceeds 325 lbs or inability to fit into MRI 
Weight and 

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scanner
maximal body 
circumference 
(if necessary) 
as self-
reported; visit 
to the MRI 
suite if 
necessary***
 16
.    
  
 Suicide attempt within the past 3 months  
 Remote 
clinical 
interview 
and medical 
history
 17
.
 Serious self-harm resulting in hospitalization within 
the past 3 months.
 Remote 
clinical 
interview 
and medical 
history
 
*For females of childbearing age: Urine pregnancy test is performed during the screening procedure and 
urine pregnancy test is repeated on MRI scanning day. Since this test cannot detect the very early stage of 
pregnancy (the10-day period between fertilization and implantation), an effective birth control method or 
sexual abstinence is required during the 15 days before the scans.
**Individuals currently using benzodiazepines will be converted to an equivalent dose of a short-acting 
benzodiazepine, which they may continue to use until 72 hours before the first tDCS session.
***In cases where there is a question about whether a participant's dimensions are compatible with the MRI 
scanner, a subject's circumference may be measured to determine if the subject's circumference is less than 
the MRI scanner limit, 200 cm. The subject also may be brought to the MRI center so that the MRI 
technologist can assess whether or not the subject will fit safely inside the MRI scanner. Metal screening 
and urine pregnancy testing will be done before this brief visit. Subjects who cannot safely enter the scanner 
will not be eligible to participate in the scanning portion of the study but may elect to remain in the study as 
a non-imaging subject.
 
Inclusion/Exclusion Criteria #2
Name the subject group/sub sample
Participants without Neuroimaging (not currently recruiting)
Create or insert table to describe the inclusion criteria and methods to ascertain them 

Protocol Summary Form
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Page 18 of 45
  Participants with NSSI without Neuroimaging: Inclusion 
Criteria
 Method of 
Ascertainmen
t
 1
.  Age 18-60
 Interview
2.
 
 Frequent current NSSI (including cutting in which the 
skin is broken; self-hitting in which there is bruising; or 
burning in which there is evidence of a burn. Will not 
enroll if skin-picking or scratching is the only form of self-
injury): has engaged in ≥ 2 episodes of NSSI in the two 
months prior to enrollment
 Self Injurious 
Thoughts and 
Behaviors 
(SITBI) scale 
and clinical 
interview
3.
  Capacity to provide informed consent
Clinical 
interview 
4.
 
If caries a diagnosis of bipolar I or II disorder, taking a 
therapeutic dose of a mood stabilizer 
SCID, clinical 
interview, 
therapeutic 
blood levels if 
applicable 
Create or insert table to describe the exclusion criteria and methods to ascertain them 
 
 Participants without Neuroimaging: Exclusion 
Criteria
Method of 
Ascertainment 
1.  Unstable medical conditions based on medical 
history of physical examination
Medical history (by a 
physician), physical 
exam, screening lab 
tests as performed 
through co-enrollment 
in IRB #4815 
2. Current psychotic disorder, mania, hypomania, 
intellectual disability 
Psychiatric interview, 
SCID 
 3. Dermatologic condition resulting in non-intact 
skin on the scalp
Medical history, 
physical exam 
 4.
 Significant suicidal ideation with a plan and 
intent that cannot be managed safely as an 
outpatient
C-SSRS, clinical 
interview 
 5.  Pregnancy, currently lactating, or planning to 
conceive during the course of study participation
serum HCG at time of 
screening
 6.
 A neurological disease or prior head trauma with 
evidence of cognitive impairment. Subjects who 
endorse a history of prior head trauma and 
score ≥ 1.5 standard deviations below the mean 
Clinical interview and 
medical history, 
Trailmaking A&B as 
needed 

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Page 19 of 45
on the Trailmaking A&B will be excluded from 
study particpation
7.  Current alcohol or substance use disorder that is 
moderate or severe according to DSM-5 criteria
SCID, urine drug test, 
clinical interview 
 8. Current opiate use disorder 
SCID, urine drug test, 
clinical interview 
9. Current medical or recreational use of any opiate 
medication 
Clinical interview, 
urine drug test 
10.
 
 Individuals who initiated or increased the dose 
of concurrent psychiatric medications (including 
antidepressants, anxiolytics, antipsychotic 
medications, mood stabilizers, and 
benzodiazepines) within two weeks prior to 
enrollment 
 Medical history, 
clinical interview
11.
 
 Individuals who initiated psychotherapy within 
two weeks prior to enrollment
 Clinical interview
12.
  
 Suicide attempt within the past 3 months  
Remote clinical 
interview and 
medical history 
13.
 
Serious self-harm resulting in hospitalization 
within the past 3 months
Remote clinical 
interview and 
medical history 
Inclusion/Exclusion Criteria #3
Name the subject group/sub sample
Sample of healthy volunteers for pilot (not currently recruiting)
Create or insert table to describe the inclusion criteria and methods to ascertain them 
 
Sample of healthy volunteers for fMRI pilot
 Method of 
Ascertainment
1. 
  
Current or past enrollment in IRB #4815 or 6786 or 
7653 or 7172 as a healthy volunteer. *
 chart review
 2
.
Written consent to be contacted about additional studies  chart review
 
*Note: if participant’s enrollment occurred more than 6 months prior to consent for this protocol, they will 
re-enroll in IRB #4815 to have medical and psychiatric assessments updated. 

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Create or insert table to describe the exclusion criteria and methods to ascertain them 
Sample of healthy volunteers for fMRI pilot
 Method of 
Ascertainmen
t
 1
.  
  
Pregnancy, currently lactating, or planning to conceive 
during the course of study participation. * 
urine HCG on 
days of MRI 
scans prior to 
scanning 
 2
.
Metal implants or paramagnetic objects contained within 
the body (including heart pacemaker, shrapnel, or surgical 
prostheses) which may present a risk to the subject or 
interfere with the MRI scan, according to the guidelines 
set forth in the following reference book commonly used 
by neuroradiologists: “Guide to MR procedures and 
metallic objects,” F.G. Shellock, Lippincott Williams and 
Wilkins NY 2001. Additionally transdermal patches will 
be removed during the MR study at the discretion of the 
investigator. 
Interview, 
MRI safety 
screening 
forms 
 3
. 
  
Claustrophobia significant enough to interfere with MRI 
scanning 
 Clinical 
interview
 4
.
  
Weight that exceeds 325 lbs or inability to fit into MRI 
scanner 
 Weight and 
maximal body 
circumference 
(if necessary) 
as part of 
physical 
exam; visit to 
the MRI suite 
if necessary 
**
 
* For females of childbearing age: Urine pregnancy test is performed during the screening procedure and 
urine pregnancy test is repeated on MRI scanning day. Since this test cannot detect the very early stage of 
pregnancy (the10-day period between fertilization and implantation), an effective birth control method or 
sexual abstinence is required during the 15 days before the scans. 
 
** In cases where there is a question about whether a participant's dimensions are compatible with the MRI 
scanner, a subject's circumference may be measured to determine if the subject's circumference is less than 
the MRI scanner limit, 200 cm. The subject also may be brought to the MRI center so that the MRI 
technologist can assess whether or not the subject will fit safely inside the MRI scanner. Metal screening 

Protocol Summary Form
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and urine pregnancy testing will be done before this brief visit. Subjects who cannot safely enter the scanner 
will not be eligible to participate in the scanning portion of the study but may elect to remain in the study as 
a non-imaging subject. 
 
Inclusion/Exclusion Criteria #4
Name the subject group/sub sample
Remote Participants with NSSI
Create or insert table to describe the inclusion criteria and methods to ascertain them 
Remote participants with NSSI: Inclusion Criteria
Method of 
Ascertainment
1. Age 18-60
Remote 
Interview
2.
Frequent current NSSI (including cutting in which the 
skin is broken; self-hitting in which there is bruising; or 
burning in which there is evidence of a burn. Will not 
enroll if skin-picking or scratching is the only form of 
self-injury): has engaged in ≥2 episodes of NSSI in the 
two months prior to enrollment
Remote Self 
Injurious 
Thoughts and 
Behaviors 
(SITBI) scale 
and clinical 
interview
3. Capacity to provide informed consent
Remote 
clinical 
interview
4. If carries a diagnosis of bipolar I or II disorder, taking a 
therapeutic dose or willing to begin a mood stabilizer*
Remote SCID, 
remote clinical 
interview, 
therapeutic 
blood levels if 
applicable
5. Normal hearing
Remote 
interview   
6.
  
Physical capacity (e.g., manual dexterity) to set-up and 
self-administer tDCS
Remote 
interview
 
 *If not currently taking a mood stabilizer, the participant will have the option of beginning mood stabilizer 
with a psychiatrist on our team. We would perform any necessary blood testing to screen for 
appropriateness of mood stabilizer treatment and to monitor blood levels. We would provide psychiatrist 
visits and any necessary blood testing, but would not cover the costs of mood stabilizer medication. If 
individuals continue to meet all other eligibility criteria once on a therapeutic dose of a mood stabilizer, we 

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would proceed with research procedures.  If they do not, we would forego research procedures and offer 
three months of open treatment.
 
 
Create or insert table to describe the exclusion criteria and methods to ascertain them 
Remote participants with NSSI: Exclusion Criteria
Method of 
Ascertainment
1. Unstable medical conditions based on medical history   
Medical history 
and remote 
medical 
evaluation
2. Current psychotic disorder, mania, hypomania, 
intellectual disability   
Remote 
psychiatric 
interview and 
SCID
3. Dermatologic condition resulting in non-intact skin on 
the scalp
Medical history 
and remote 
medical 
evaluation
4. Significant suicidal ideation with a plan and intent that 
cannot be managed safely as an outpatient
Remote C-
SSRS and 
clinical 
interview
5. Pregnancy, currently lactating, or planning to conceive 
during the course of study participation*
Urine HCG 
prior to first 
tDCS session
6.
A neurological disease or prior head trauma with 
evidence of cognitive impairment. Subjects who 
endorse a history of prior head trauma and score ≥ 1.5 
standard deviations below the mean on the Trailmaking 
A&B will be excluded from study participation 
Remote clinical 
interview and 
medical history, 
Trailmaking A 
& B as needed
7.  
  
Current alcohol or substance use disorder that is severe 
according to DSM-5 criteria 
Remote SCID 
and clinical 
interview
8.
Individuals who initiated or increased the dose of 
concurrent psychiatric medications (including 
antidepressants, anxiolytics, antipsychotic medications, 
and mood stabilizers) within two weeks prior to 
enrollment
Remote clinical 
interview and 
medical history
9. Individuals who initiated psychotherapy within two 
weeks prior to enrollment 
Remote clinical 
interview

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10. Current seizure disorder
Remote clinical 
interview and 
medical history 
11. Use of anticonvulsant medications that target the 
GABA system (e.g., gabapentin)
Remote clinical 
interview and 
medical history 
12.
   
Individuals currently using benzodiazepines who are 
unable or unwilling to refrain from the use of 
benzodiazepine medications for at least 72 hours before 
the first tDCS session and throughout the duration of 
the 2-week tDCS intervention**
Remote clinical 
interview and 
medical history 
 13
.
Suicide attempt within the past 3 months 
Remote clinical 
interview and 
medical 
history 
14.
 
Serious self-harm resulting in hospitalization within 
the past 3 months. 
Remote clinical 
interview and 
medical 
history 
 
*For females of childbearing age: Urine pregnancy test is mailed to the participant with instructions for 
performing the test. Results are captured with a photo and sent to the experimenter through REDCap or 
attach.nyspi.org. 
**Individuals currently using benzodiazepines will be converted to an equivalent dose of a short-acting 
benzodiazepine, which they may continue to use until 72 hours before the first tDCS session.
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
No
Waiver of documentation of consent 
No
Waiver of parental consent 
No

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Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
Yes
Indicate NYSPI IRB #
4815
Describe Study Consent Procedures
Sample of patients with NSSI:
Following preliminary determination of eligibility, informed consent procedures will be conducted by the
physicians listed in the following section. Initial screening will completed as detailed in IRB #4815. For all
remote procedures, the consenter will connect with the subject over the phone or a videoconference and will
go through all relevant documents, including the HIPAA form and consent form, with the participant.
Participants will provide an electronic signature through RedCap's e-signature option. Consent for remote
clinical or research procedures will be documented, and the consent discussion process will include
discussion of the technology HIPAA-compliant platforms to be used and any concerns the patient may have,
such as access to a private space in which to take calls, or accessibility—access at home to adequate
devices, cell signal, or Wi-Fi. There will be a consent procedure note that includes that there was a
discussion of risk related to COVID-19 during travel. Consent discussions will include informing
participants of the option to reschedule if travel does not seem safe and/or the study team may offer
alternative transportation, such as Uber or Lyft.
Sample of healthy volunteers for fMRI pilot:
Initial screening will be completed as detailed in IRB #4815 through current or past enrollment in
IRB #6786 or 7653 or 7172. If 6 months or more have passed since the initial screen, participants will be re-
screened using the procedures detailed in IRB #4815. Informed consent procedures will be conducted by
one of the researchers listed in the following section.
Indicate which of the following are employed as a part of screening or main study consent procedures
Consent Form
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Grunebaum, Michael, MD
Lan, Martin, MD
Miller, Jeffrey, MD
Sublette, M, MD
Type in the name(s) not found in the above list

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Study Procedures
Describe the procedures required for this study
I attest to follow the COVID-19 Safety Guidelines for Columbia Psychiatry and NYSPI Re-Entry outlined 
in the NYSPI Director’s June 1st memo, which include but are not limited to:
• Infection Control/PPE – Guidelines
• Research participants will only come on-site if absolutely necessary for study procedures.
• No volunteers/externs on-site during Stage 1.
• Clinical research teams will screen their participants for COVID symptoms (night before and day of onsite 
visit, documenting this in the chart), and escort them in and out of the building.
• COVID/COVID-like symptoms in participants will be reported to the IRB via PRISM as an SAE.
 
Sample of patients with NSSI:
All of the study procedures are listed below. Participants who enroll in the arm of the study without 
neuroimaging will follow all procedures described below with the exception of the neuroimaging-related 
procedures (MRI). Participants will follow all procedures described below remotely, with the exception of 
the neuroimaging-related procedures (MRI). For females of childbearing age, a urine HCG test will be sent 
by mail with instructions detailing how to use the test. Participants will be asked to photograph the results of 
the test and upload them through RedCap or attach.nyspi.org. For both arms of the study, participants will 
have the option of receiving tDCS in-person or remotely.
Subjects who frequently engage in NSSI will be recruited as described above and will co-enroll in the brief 
medical assessment arm of IRB Protocol #4815. Following informed consent for participation, screening 
evaluation will be performed at study entrance through IRB protocol #4815 and will include a complete 
medical history and remote clinical examination to exclude significant physical illness. 
Psychological Assessments
Psychological assessments and their timing are described in the “Assessment Instruments” section. 
Real-Time Monitoring of NSSI, Stressors, and Urges 
In addition to using retrospective reports of NSSI, we will also employ a recently developed assessment, 
Ecological Momentary Assessments (EMA). EMA records thoughts, feelings and behaviors and the 
circumstances preceding these experiences in real time, which may allow for a more accurate understanding 
of mood and behavior than retrospective reporting (Nock et al., 2009). 
In this study, we will use EMA to have participants rate the frequency, duration, and severity of urges to 
engage in NSSI, the frequency and nature of actual NSSI, as well as suicidal ideation, relevant affects, 
stressors and behaviors, and possible triggers for these events, for one week prior to treatment, through the 
duration of the course of tDCS treatments, and one week following completion of tDCS, to measure the 
persistence of any observed effects. These items will be presented to each participant on an iPod device 
during each momentary assessment. We will enter each subject’s self-reported typical waking and bedtime 

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into the software. Using this information, the program will stratify waking hours into six intervals, then 
randomly select one moment within each interval to deliver a prompt of an audible beep. This beep will be 
repeated every 30 seconds for up to 5 minutes. Collected data will be downloaded when the device is synced 
with a computer and can be easily imported into standard spreadsheets or statistical packages. If the 
participant records the presence of treatment emergent suicidal ideation, an open-ended question allowing 
the subject to record descriptions of their experience with this development will be presented. Subjects will 
also be reminded about emergency procedures to contact staff if they are concerned about suicidal ideation 
or risk. 
We have used this procedure in a NIMH-funded study of actively suicidal patients without adverse effects 
and with good adherence. 
MRI Scans: 
MRI images will be acquired at the New York State Psychiatric Institute on a GE SIGNA Premier 3T MRI 
scanner. Subjects will undergo T1-weighted structural imaging and a functional EPI, during which the 
Cyberball task will be presented (described below). If time allows, they may undergo diffusion tensor 
imaging (DTI) as well as a resting-state fMRI scan. Scans will not last more than 60 minutes. Because these 
MRI scans are being performed for research purposes only, they may not show problems that would 
normally be found in a typical clinical MRI scan ordered by a doctor for a specific medical problem. The 
T1-weighted images acquired in this study, regardless of resolution of other image characteristics, do not, in 
general, yield adequate information for a clinical quality read. However, gross structural abnormalities such 
as the presence of mass effects or hydrocephalus will be examined and documented by an appropriately 
qualified radiologist. Upon request, results will be shared with research subjects or a physician designated 
by them. When there is evidence of a mass lesion, hydrocephalus or other significant abnormality, a 
qualified clinician will call the subject and then a letter will be sent, depending on the urgency, and at the 
discretion of the investigator and neuroradiologist. 
Heart Rate Variability:
 
Participants will be outfitted with MR-safe ECG leads in a lead II configuration before entering the scanner. 
The lead II configuration places the positive electrode near the lower left rib and the negative electrode near 
the right arm, just below the clavicle. This configuration maximizes the R spike of the QRS wave complex. 
A third reference lead can be placed on either the lower right rib or near the left arm. Placement on the trunk 
rather than limbs will minimize artifacts due to movement. 
tDCS: 
All tDCS sessions for participants who do not participate in neuroimaging, may occur either remotely (see 
section below on "Remote tDCS") or at the M.I.N.D. Clinic at NYSPI and will be conducted by Dr. Miller, 
who has completed training in tDCS with Dr. Javitt and his staff, by Dr. Yttredahl, who has previous 
experience administering and training in the use of tDCS, or by another staff member listed in the study 
personnel after they complete training in tDCS by Dr. Miller or Dr. Yttredahl. Dr. Miller or Dr. Yttredahl 
will be available at all times during tDCS administrations. 1.5mA of stimulation will be applied for up to 20 
minutes at each treatment. Participants will be randomly assigned to receive either sham stimulation, which 
consists of a ramp-up to 1.5mA followed by an immediate ramp-down and 20-minutes of no-stimulation, or 

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active stimulation which consists of 20-minutes of stimulation at 1.5mA between the ramp-up and ramp-
down. Both participants and researchers will be blind to the tDCS assignment. The anode will be positioned 
over right ventrolateral prefrontal cortex (vlPFC), and the cathode will be positioned over the left supra-
orbital area. Non-metallic, conductive rubber electrodes will be used, as recommended by Nitsche and 
Paulus, 2000. Electrode sponges will be kept moist in order to avoid skin irritation and will be secured using 
non-conductive elastic bands. If using paste, an even application of Ten20 paste will be spread on the 
electrodes to sit between the electrode and the skin to avoid skin irritation.  If contact quality becomes 
suboptimal during tDCS, additional conductive gel may be applied to the electrodes. tDCS administrations 
will be performed using the Mini-CT from Soterix Medical Inc. Soterix is a well-established company 
creating and supplying research- and clinical-grade tDCS devices that have been used in over 200 published 
studies since 2012 and is currently involved in 29 different clinical trials worldwide. The Mini-CT was 
designed specifically for use in clinical trials and has built-in safety features that can even allow remotely-
supervised self-administration by participants.  tDCS will be administered two times per day for six 
alternating days, for a total of 12 sessions. If scheduling conflicts prevent sessions over three alternating 
days exactly, we will administer tDCS as close to this schedule as possible. 
Participants will have the option to receive tDCS either remotely or in-person at NYSPI. tDCS administered 
in-person will be applied in an office suite while the tDCS administrator remains socially distanced, 
maintaining visual and auditory contact throughout the session, in an adjacent room. Both the participant 
and the research staff member will don face masks for the duration of the tDCS session. Participants 
receiving tDCS in-person will be scheduled with no less than 1 hour between appointments. During the time 
between participants, researchers will disinfect all surfaces in the participant area and the tDCS device with 
Super Sani Cloths or similar alcohol-based disinfectant cloths.
 
Attention Training Technique: 
 
During tDCS, participants will undergo the Attention Training Technique (ATT). This task involves 
listening to an approximately 12-minute audio file at a comfortable volume over a pair of headphones, 
earbuds, or stereo speakers. Participants are asked to focus on a visual fixation point in the room and engage 
in three attention exercises: 1)selective attention (focusing on indivisual sounds), 2) attention switching 
(shifting attention between different sounds), and 3) divided attention (attending to sounds simultaneously).
Open Treatment: 
Beginning one week after the conclusion of the tDCS treatment week, participants will be offered 3 months 
of medication-based treatment with a psychiatrist in our division. 
Cyberball: 
Participants will be presented with animated drawings depicting the participant's avatar and two other 2 
cartoon figures tossing a ball between each other and the participant. When the participant's avatar receives 
the ball, they will press one of two buttons indicating which of the other two cartoons will receive the ball 
next. The number of times the ball is tossed to the participant will vary each block, such that the participants 
feel excluded from the game to varying degrees. Participants will be told before the study that the other 
characters are not real people and that they are not really playing the game with other people, but asked to 
imagine it as though it were real. At the end of each scan, an investigator will check in with the participant 

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to make sure the task did not cause significant, lasting distress. If the participants are upset following the 
task, a clinician will be available to speak with the participant. After scan 2, the check-in will include a full 
debriefing about the purpose of the task, including an explanation that Cyberball is a simulation of social 
exclusion. During debriefing, participants will be reminded that the task was only a computer game and the 
other players were not real people. 
Remote tDCS:
Following consenting procedures, remote patients with NSSI will participate in all above procedures with 
the exception of in-person medical assessment and neuroimaging-related procedures (MRI). All 
assessments, clinical interviews, and procedures will be administered remotely. Cyberball will be presented 
through the computer outside of an fMRI scan. Participants will be provided with a tDCS device, headgear, 
and supply kit through the mail, and will be trained on tDCS self-administration over a HIPAA-compliant 
video-conferencing software (either CUIT-supported Zoom or NYS WebEx) by Dr. Yttredahl or Dr. Miller. 
Participants may be provided a laptop or tablet and headphones in their tDCS kit to ensure access for those 
who may not otherwise have the ability to use the videoconferencing software at home. The Mini-CT, our 
tDCS device, is intended for home use; it can be controlled via single-use codes that will be provided before 
each session once the researcher supervising the session confirms proper placement of the electrodes 
through visual inspection over the secure video-conferencing platform. Using these codes, the dose and 
timing will be controlled remotely, and the device will not operate without a code. Each tDCS session will 
be supervised over a HIPAA-compliant video conferencing platform by either Dr. Yttredahl or Dr. Miller. 
The participant will be trained in how to terminate the tDCS stimulation at any time should they experience 
significant adverse effects during stimulation. The audio file for the ATT will be sent to participants who 
may then use their own (or researcher-provided) speaker or headphone system to listen to the task during 
each tDCS session. Audio setup will be tested with a test audio file (not the ATT) to confirm that the audio 
system is functioning properly prior to initiating tDCS. In addition to instructions received by the research 
staff member (Dr. Miller or Yttredahl) during the videoconference, participants will also be provided with 
detailed instructions and diagrams explaining the setup and use of the device. Participants will be instructed 
to re-package the device, accessories, and any other borrowed equipment (e.g., tablet) in the provided box 
and mail the package back to the experimenters using a prepaid label included in the kit.
 
Sample of healthy volunteers for fMRI pilot:
Following consenting procedures, volunteers will participate in the social feedback task listed in the 
previous paragraph during fMRI scanning. MRI images will be acquired at the New York State Psychiatric 
Institute on a GE SIGNA Premier 3T MRI scanner. Subjects will undergo T1-weighted structural imaging 
using the same procedures listed above. Participants will also undergo functional imaging during the task 
presentation. The entire scan session is expected to last approximately 30 minutes but may take up to one 
hour. Participants will undergo fMRI twice on separate days with at least 5 days between scan sessions.
 
Personnel and Responsibilities 
1. Medical exam and history: physician
2. Psychiatric Interview: physician or psychologist
3. Semi-structured interview: physician, psychologist or research interviewer

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4. tDCS administration: Jeffrey Miller, M.D., Ashley Yttredahl, PhD, Sarah Herzog, PhD, at NYSPI;
5. Radiologists designated to read MRI research scans: radiology staff at Imaging On Call 
(www.imagingoncall.com)
6. Psychologists conducting psychological ratings 
a. Masters or doctoral-level research psychologists within our division 
7. Staff assisting Dr. Miller or Dr. Yttredahl with tDCS at NYSPI: 
a. Sarah Herzog, PhD
b. Olivia Kolodka
c. Rachel Velasquez
d. Sophia Capri 
e. Evan Lieberman
f. Lisette Thurkill
g. Ella Sudit 
Data and safety monitoring plan: 
Overview: Given that we are conducting a small pilot trial of a minimal risk intervention in which 
concurrent ongoing treatments are permitted, we have developed a data and safety monitoring plan, as 
described below, to ensure and oversee the safety of participants. 
PI/IRB involvement: Approval for the proposed study and all amendments will be obtained by the NYSPI 
IRB before any procedures or changes in procedures take place. The PIs will be responsible for monitoring 
all procedures related to the study and ensuring safety of participants. The tDCS equipment will be operated 
under IDE exemption under the oversight of the NYSPI IRB. tDCS is considered a minimal risk procedure 
that may be associated with discomfort during stimulation (e.g. itching, tingling, burning) related to the 
scalp electrical fields but which has not been associated with lasting sequelae following completion of 
stimulation. The PIs, in conjunction with the relevant IRBs will maintain oversight of AEs. Serious adverse 
events, should they occur, will be reported by the PIs to the IRBs. 
Staff Experience: Staff in the Division of Molecular Imaging & Neuropathology at NYSPI have extensive 
experience and training in the assessment of patients with suicidality and self-injurious behavior. Drs. Miller 
and Stanley will review principles of safety assessment with the staff involved in this research (research 
psychologists, research coordinators) prior to study initiation, and will conduct follow-up training and 
supervision as needed. 
Independent safety officer: Because of potential discomfort induced by tDCS, a Columbia psychiatrist not 
involved with the study will serve as an independent individual/safety officer. This psychiatrist will 
periodically review reported side effects and will notify the PIs should there be significantly higher than 
anticipated incidence of side-effects, in which case appropriate adjustments will be made to the stimulation 
protocols, and case procedures would be reviewed. The psychiatrist will also review the Clinical Global 

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Impression rating, the Columbia Suicide Severity Rating Scale rating and adverse event reports to ensure 
that no unanticipated side effects are observed.
Annually, the PIs will prepare a summary of data safety monitoring activities, as requested, in the annual 
progress reports to the IRBs and will also provide this report to the psychiatrist who is serving as the 
independent reviewer. These reports will include: (1) whether participants’ safety, privacy and 
confidentiality has been consistently assured by the investigators; (2) review of interim data analyses that 
bear on outcomes of the study and risk/benefit ratios to participants, including recommendations for 
statistical analyses; (3) judgment as to whether research instruments have been administered in a uniform 
manner and in a way that maintains the participants’ privacy; (4) a review of the study’s progress toward 
recruitment goals, quality of data (e.g., appropriate completion of forms), and participant retention/attrition 
rates; and, (5) a review of new scientific literature pertinent to the safety of participants or ethics of research 
participation. 
There will be regular, ongoing communication between the PIs and the IRBs as well as with the independent 
psychiatrist. While no serious and unexpected adverse events are expected, any unanticipated study 
problems will be reported to both IRBs. The study personnel will take all clinically appropriate actions to 
prevent and treat psychiatric emergencies in participants. 
Rationale for monitoring strategy: As per PHS guidelines (PHS SF424, section 4.15), other potential 
monitoring plans include a designated medical monitor; an Internal Committee or Board, or Data Safety and 
Monitoring Boards (DSMB). DSMBs are required for phase III and multisite studies, but, as per guidance, 
“smaller clinical trials may not require this oversight format and alternative monitoring plans may be 
appropriate”. In the case of this study, we note that the number of subjects is small and that tDCS is 
considered a minimal risk device that has been extensively used in prior human research. Thus, we feel that 
a DSMB would entail unnecessary administrative burden, and use of an independent safety officer, as 
above, represents the most appropriate level of oversight. 
You can upload charts or diagrams if any
Criteria for Early Discontinuation  
Criteria for Early Discontinuation
A CGI-Improvement score at any time point of 6 or 7 (“much worse” or “very much worse”) will trigger 
clinical evaluation by the study investigators, Drs. Miller or Stanley, for possible study discontinuation. We 
will assess suicidal ideation and behavior weekly from the time of consent through the completion of tDCS 
procedures. If individuals endorse suicidal ideation that includes a plan and intent, or have made an actual 
suicide attempt, research procedures will be discontinued, and open clinical treatment will be initiated 
immediately at an appropriate level of care. 

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Blood and other Biological Samples
Please create or insert a table describing the proposed collection of blood or other biological specimens
No blood is drawn through participation in this IRB protocol. 
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
Sample of patients with NSSI:
 
Through co-enrollment in IRB #4815, participants will undergo a careful psychological assessment 
including characterization of DSM-IV diagnoses using the Structured Clinical Interview for DSM-IV 
(SCID, (First et al., 1995; First et al., 1997)). Recent suicidal ideation and behaviors will be assessed using 
the Columbia Suicide Severity Rating Scale (C-SSRS), which will be repeated on a weekly basis during 
tDCS administration to monitor emergent suicidal ideation (Posner et al., 2011). Selected items from the 
Self-Injurious Thoughts and Behaviors Interview (SITBI) will be used at baseline and on a weekly basis to 
monitor self-reported frequency, nature, motivations, and effects of NSSI, as well as urges to engage in 
NSSI, throughout study participation. Selected items from the Non-Suicidal Self-Injury Assessment Tool 
(NSSI-AT) will also be acquired at baseline to acquire additional information regarding history of NSSI 
behavior. The Clinical Global Impressions scale (CGI) (Guy et al., 1976) will be conducted on a weekly 
basis to monitor for clinical worsening. Possible mediators of treatment outcome that will be examined in 
the study include: emotion regulation using the Difficulties in Emotion Regulation Scale (DERS, (Gratz et 
al., 2004)) and the Cognitive-Attentional Syndrome Questionnaire (CAS-1; Wells, 2009); engagement with 
the ATT with the ATT-Scale; trait rumination with the Ruminative Responses Scale (RRS; Treynor et al., 
2003) expectancy of clinical benefit, assessed with the Credibility/Expectancy Questionnaire (Devilly et al., 
2000); and depression severity, as assessed by the Hamilton Depression Rating Scale (HDRS, (Hamilton, 
1960)) and the Beck Depression Inventory (BDI, (Beck et al., 1961)). Tolerability of tDCS will be evaluated 
using the tDCS Adverse Effects Questionnaire (Aparicio et al., 2016). 
 
Sample of remote-only patients with NSSI: Rater-administrated psychological assessments will be 
administered by phone or secure video-conference, and participants will be sent a link to complete self-
report measures remotely through a secure platform (either REDCap, SIR, or Qualtrix). Cyberball will be 
remotely administered within one week before the first tDCS session and within one week after the final 
tDCS session. The original version of Cyberball was administered and validated for use as a digital task 
outside of the scanner (Williams, Cheung, & Choi, 2000). 
 
 Table: Timing of Psychological Assessments 

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Assessment 
Enrollment
Baseline 
(prior to 
Session 1)
Post-
Final 
tDCS 
Session
Following 
each tDCS 
session
One week 
Post-
treatment 
4 week 
Follow
-up
Credibility/Expectancy 
Questionnaire (CEQ)
 
X 
 
 
 
Columbia-Suicide Severity Rating 
Scale 
(C-SSRS)
 
 X
X
 
 X
 X
Selected items from the Self-
Injurious Thoughts and Behaviors 
Interview (SITBI) 
 
 
X
 X
 
 
X
 
 X
 X
Selected items from the Non-
Suicidal Self-Injury Assessment 
Tool
(NSSI-AT)
 
 
X
 
 
 
 
 
Clinical Global Impressions (CGI)
 
 X
X
 
X
X
Difficulties in Emotion Regulation 
Scale (DERS)
 
 X
X
 
 
 
Hamilton Depression Rating Scale 
(HAM-D)
 
 X
X
 
 
 
Beck Depression Inventory (BDI)
 
 X
X
 
 
 
tDCS Adverse Effects Questionnaire  
 
 
 X
 
 
 Cognitive-Attentional Syndrome 
Questionnaire (CAS)
 
 X
 X
 
 
 ATT-Scale
 
 
 
 X
 
 
 Ruminative Responses Scale (RRS)  
 X
 X
 
 
 
Criteria for Early Discontinuation
A CGI-Improvement score at any time point of 6 or 7 (“much worse” or “very much worse”) will trigger 
clinical evaluation by the study investigators, Drs. Miller or Stanley, for possible study discontinuation. We 
will assess suicidal ideation and behavior weekly from the time of consent through the completion of tDCS 
procedures.  If individuals endorse suicidal ideation that includes a plan and intent, or have made an actual 
suicide attempt, research procedures will be discontinued, and open clinical treatment will be initiated 
immediately at an appropriate level of care.  
 
State-Emotion Questions 

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During the social feedback task, participants will be asked to rate how they are currently thinking and
feeling using select items from the PANAS (Watson et al., 1988), as well as some items used in a previous
study (Yttredahl, 2019) assessing rumination and self-esteem.
Sample of healthy volunteers for fMRI pilot:
Criteria for Early Discontinuation
Non-patient participants can choose to discontinue participation at any time.
Please attach copies, unless standard instruments are used
Off label and investigational use of drugs/devices
Choose from the following that will be applicable to your study
Device
Off label and investigational use of devices
Device #1
Name of the device
Soterix Mini-CT
Manufacturer and other information
Soterix Medical, Inc., New York City, NY.
Approval Status
No IDE is required
Choose one of the folowing options
Device is 'Non-significant risk'
Explain
No serious adverse events have been attributed to tDCS administration in over 10,000 subjects reported in
any studies published in the modern era of tDCS, from 1998 to 2014 (Fregni et al, "Regulatory
considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and
recommendations from an expert panel; Clin Res Regul Aff. 2015 Mar 1;32(1):22-35). The risks to human
subjects directly associated with tDCS administration include a mild tingling sensation, slight epidermal
irritation and mild temperature change at the site of application during administration (42); these do not tend
to persist beyond the completion of the tDCS stimulation. Mild headache has been occasionally reported
with tDCS, but typically responds to acetaminophen, ibuprofen, or aspirin. As such, devices used to
administer tDCS have routinely been determined to be non-significant-risk devices by IRBs in the United
States (Fregni et al, 2015). Moreover, standard tDCS parameters considered to be minimal risk have been
published in terms of dose (<2.5mA), duration (≤60 minutes), frequency (≤2 treatments per day), and

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electrodes employed (Fregni et al, 2015). The parameters proposed in this study are all well within these 
standard parameters.
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
Yes
Maximum duration of delay to any treatment 
Study participants may continue with ongoing psychotherapeutic and/or pharmacologic treatment, as long as 
it was not started within 8 weeks of study enrollment. For participants not currently receiving psychiatric 
treatment, there may be a delay of up to 35 days prior to initiating tDCS through the study, in order to 
schedule baseline assessments, MRI scanning. For patients with bipolar 1 or 2 disorder not on a therapeutic 
dose of a mood stabilizer, evidence-based treatment with mood stabilizer treatment will be offered that 
would begin within 3 weeks of enrollment; tDCS research procedures would be further delayed in this case 
for the purposes of achieving a therapeutic dose of a mood stabilizer (prioritizing this clinical treatment 
ahead of research procedures). 
Maximum duration of delay to standard care or treatment of known efficacy
Eight weeks
Treatment to be provided at the end of the study
One week following the conclusion of tDCS procedures, open medication-based treatment will be offered to 
study participants for a period of three months.
Clinical Treatment Alternatives
Clinical treatment alternatives
Alternative treatments for NSSI include a form of psychotherapy called dialectic behavioral therapy. While 
there are no FDA-approved medications for the treatment of NSSI, medications are sometimes used to treat 
NSSI based on previous research findings. 
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
Risk 1 applies only to the neuroimaging participants. Risks 2 through 5 apply to all participants.
 
Risks associated with participation in this study are related to 1) pregnancy; (MRI); 2) discomfort during 
scanning (MRI); 3) MRI scan; 4) transcranial direct current stimulation (tDCS); 5) psychological interviews
1. MRI Scan
The MRI scanner uses a large magnet (3 Tesla) to take pictures of the brain and is not associated with any 
known medical risks, except for persons who have a heart pacemaker, or have metal in their body (e.g. 

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shrapnel or surgical prostheses) which may be affected by the magnet. Subjects will be asked to notify us if 
this is the case. The long-term effects of being placed in a magnet of 3T are unknown. Although there are no 
known risks associated with pregnancy, we will not scan someone who is known to be pregnant. There is 
also the risk of burns from medicinal patches during the MRI; therefore, subjects will be asked to remove 
any patches prior to the scanning session. Some people have reported sensations during the MRI scan, such 
as "tingling" or "twitching" (or, very rarely, a painful sensation), which are caused by changes in the 
magnetic field that can stimulate nerves in the body. Occasionally, some people experience nervousness or 
claustrophobic feelings due to the scanner's small space. Despite these experiences, in our experience, no 
one has had sensations from the scanning that did not stop as soon as the scanning stopped. The MRI scan is 
not painful, but having to lie still in the enclosed space of the scanning table is uncomfortable for some 
people.
 
2. Transcranial direct current stimulation (tDCS)
The risks to human subjects directly associated with tDCS administration include a mild tingling sensation, 
slight epidermal irritation and mild temperature change at the site of application during administration 
(Brunoni et al., 2011); these do not tend to persist beyond the completion of the tDCS stimulation. Mild 
headache has been occasionally reported with tDCS, but typically responds to acetaminophen, ibuprofen, or 
aspirin. During the period of tDCS administration, the participant will be closely and regularly observed and 
asked to report any adverse effects. Subjects may opt to discontinue at any point. We will also regularly 
debrief subjects following tDCS sessions to detect patterns or procedures that might be associated with 
discomfort and will modify procedures as necessary. Similarly, we will continuously monitor the literature 
for procedures that might reduce risk of any discomfort. Participants will complete the tDCS Adverse 
Effects Questionnaire (Aparicio et al., 2016) following each tDCS administration to acquire systematic data 
regarding tolerability and side-effects. Any severe or intolerable side-effects will lead to the immediate 
cessation of the tDCS stimulation, and clinical monitoring and treatment by Dr. Miller or other M.I.N.D. 
division physicians, who will treat and monitor the symptoms until they resolve, and also closely follow up 
with the participant to ensure that the symptoms have not persisted. All adverse events, including serious 
ones, will be reported to the NYSPI IRB, with a review of procedures to determine whether the protocol 
should be modified accordingly. There are no specific risks related to using two different devices for tDCS 
in this study. Remote supervised self-administered tDCS has been successfully and safely performed in 
dozens of studies (Hordacre, 2018). All sessions will be supervised by Dr. Miller or Dr. Yttredahl, who will 
use the current best practices in remote administration of tDCS (Charvet et al., 2015, 2020; Shaw et al., 
2017), with guidance and consultation from Dr. Leigh Charvet of NYU, an expert of remote administration 
of tDCS in clinical research, as needed. The device provided to participants in the remote arm of the study is 
intended for use with remote self-administration, and has been validated for this purpose (clinical uses 
include treatment for ALS (Sivaramakrishnan et al., 2019), MS (Charvet et al., 2018; Kasschau et al., 2016), 
and Parkinson’s Disease (Agarwal et al., 2018; Cucca et al., 2019)), and doses are strictly controlled by 
single-use codes that will be provided to the participants during each session once proper electrode setup 
and placement has been confirmed visually. Research has shown that the adverse events associated with at-
home tDCS are the same as those of in-person tDCS and consist primarily of superficial, temporary 
discomfort such as itching, tingling, or burning sensations (Cucca et al., 2019).
3. Psychological Interviews
Psychological and neurocognitive assessments can be boring, tiring and sometimes disturbing.
 

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4. EMA: 
EMA may be mildly stressful. We have administered the EMA to >50 patients with Borderline Personality 
Disorder with recent suicide attempts and/or NSSI with no adverse effects. We obtained usable data from 
98% of the participants. Data will be downloaded on the next visit to the institution. Once an assessment is 
completed the participant nor anyone else accessing the device will be able to see the responses. 
 
5. Cyberball:
Participants may feel upset, annoyed, bored, or angry during the game, especially during exclusion trials.
 
6. Attention Training Technique:
The ATT could be boring, but is not associated with additional significant risks.
 
7. COVID-19
There is a risk of being infected with COVID-19 while traveling to and from the medical center. 
 
Describe procedures for minimizing risks
1. MRI Scan
For women of childbearing years, urine pregnancy testing will be conducted the day of the MRI. If the 
subject experiences sensations and feels uncomfortable, the MR technologist will stop the scan immediately. 
Our research staff will be present at all times, and a staff psychologist or psychiatrist will be available at all 
times, should the subject experience any difficulties.
 
2. Transcranial Direct Current Stimulation
Routine safety procedures are in place to screen subjects prior to scanning, maintain security of the 
restricted access areas, and ensure that system security features are in good working order. A research 
physician will be present at all times to monitor patient safety. Operation of cellular (wireless) devices, 
telephones, or two-way radios may produce changes in device output, and thus should not be used in close 
proximity (< 1m).
We do not apply electrodes over broken or irritated skin. The use of other stimulation electrodes during the 
treatment period will be avoided. Lead wires are configured so that they cannot be plugged into power 
outlets such as wall sockets and line cord receptacles.
To ensure participants can safely self-administer tDCS, the following extra procedures will be added to the 
remote tDCS arm of the study:
a. All tDCS sessions will be monitored over a HIPAA compliant videoconferencing software (either NYS 
WebEx or CUIT-supported Zoom) by a trained researcher. We use secure videoconferencing software that 
is HIPAA compliant and approved for this use by our institution. While quite unlikely, there is a small risk 
that conversations that take place through videoconference could be intercepted, heard, or viewed by other 
individuals. Before beginning the tDCS, participants will be fully familiarized with all equipment, including 
how to immediately abort a stimulation session in the case of discomfort.
b. tDCS dosing will be strictly controlled by using a device that only starts a stimulation protocol when a 
single-use code is input. Thus, the device can only be activated by the participant once the supervising staff 
member has ensured all setup has been performed correctly, and the single-use codes will activate a 
montage with a pre-set intensity, duration, and condition (sham versus active). In addition, this device has 

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an automatic shut-off feature that will cause the stimulation to abort if the impedance goes above a preset 
threshold (a common cause of discomfort). In the case of an aborted session due to high impedance, 
participants will be guided to add additional saline to the sponges using syringes that have been prepared 
with saline and included in the tDCS kit.
c. A specialized headstrap (SNAPstrap), designed by Soterix to hold the electrodes at pre-determined 
positions on the scalp, will be used to ensure simple and consistent placement of electrodes on the scalp. 
The use of this strap will be further monitored by staff via a HIPAA compliant videoconferencing software 
before stimulation codes are provided.
d. For hygiene and to control the amount of conductive saline used during each session, single-use pre-
soaked electrode sponges from Soterix will be provided to the participant. These sponges are packaged to 
include the correct amount of saline and designed to snap into the headstrap at the designated locations.
e. The protocol includes the following specific stop/go criteria for each step of the at-home administration, 
derived from the criteria published by Dr. Leigh Charvet (Charvet et al., 2020):
1. Stimulation will not proceed unless teleconferencing has been initiated with video and audio 
communication established. At least two forms of communication with the participant (e.g., 
telephone and videoconferencing) will be secured and tested before the first tDCS session. If the 
connection is lost during a session, the study technician will attempt to reestablish communication 
using the second form of connection. Participants will be instructed to abort the tDCS session if 
communication is lost. Training and practice on how to abort a session will occur before the first 
tDCS session.
2. Electrode preparation and position on the scalp has been visually verified by the study technician. 
Intact skin will be assessed through a visual inspection by the researcher through videoconferencing 
and verbally confirmed with the participant. Electrode preparation will be assessed by guiding and 
monitoring the participant on the setup of the electrodes and strap over videoconference. To position 
and hold the electrodes in place, we will be using a SNAPstrap from Soterix. This headgear was 
designed to be used in the home setting and is customized to fit electrodes at the correct anatomical 
locations needed for our specific montage. The strap has two holes, one for each electrode, that are 
placed in the correct location on the band and are color-coded to match the polarity of the electrode 
cables. Participants will be instructed to snap the electrodes into the color-matching holes and place 
the device on their heads so that the band lays across their forehead and an easily-visible marker on 
the front of the strap is centered between the eyebrows. The researcher will confirm that the strap is 
placed in the correct position by visually verifying the alignment of specified marks on the strap with 
anatomical landmarks on the head.
3. During the first 1-2 minutes of stimulation, following a complete ramp-up of current, participants 
will be asked to identify any physical sensations and rate them on a scale of 0-10. If any sensation is 
given a rating >4, participants will be asked whether the stimulation is tolerable. If necessary, the 
session will be aborted and the study technician will instruct the participant on how to adjust the 
electrode preparation to attempt to reduce impedance. If tolerability cannot be achieved, tDCS will 
not continue and the session may be rescheduled or the participant may be removed from the study, 
as needed.
3. Psychological interviews
Psychological interviews will be performed by trained staff who are sensitive to their potential effects. 
Subjects may become distressed during testing, in which case, testing will be postponed.

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4. EMA: Subjects will not download EMA data themselves and they will not have access to it once a 
session is complete. We provide information about who to contact if the participant feels suicidal either 
during the EMA or at any other point. 
 
5. Cyberball
Participants will be informed that they can stop the study procedures at any time without consequence. 
Participants will also be informed that the feedback they receive is not real, but is instead generated by 
researchers to study their responses to different types of feedback. In addition, a study clinician will be 
available as needed if the task causes substantial distress and patients will be carefully monitored for the 
duration of the study for any adverse effects of study procedures or worsening of symptoms. Social 
feedback paradigms have been administered safely in other studies of patients who engage in NSSI (Brown 
et al., 2017; Malejko et al., 2019).
 
6. Attention Training Technique
Participants will be informed that they can stop the study procedures at any time without consequence.
 
7. COVID-19
In order to minimize the risk of travel we will instruct all subjects in the importance of social distancing and 
wearing a mask at all times during travel to and from NYSPI as well as in NYSPI. On the days of the MRI 
scans we will offer to pay for an Uber ride for subjects living in the extended New York metropolitan area. 
 
8. Mood stabilizer treatment and associated blood monitoring (if applicable): If participants are 
diagnosed with bipolar 1 or 2 disorder and are not on a therapeutic dose of a mood stabilizer at the 
time of study enrollment, they may begin mood stabilizer treatment with a study physician.  The risks 
of any mood stabilizer medication and alternatives will be discussed with participants in detail before 
initiating a trial.  Mild discomfort can be expected from blood drawing that may be done to screen for 
medical conditions prior to beginning a mood stabilizer, and to measure blood levels of mood 
stabilizer medication. Sometimes a bruise will occur at the puncture site. Less than 40ml of blood will 
be drawn for this purpose.
Methods to Protect Confidentiality
Describe methods to protect confidentiality
Personal information will be kept confidential and will not be released without the subject’s written 
permission except as described in this section or as required by law. The subject’s name or other identifying 
information will not be made known if the results of this study are published for scientific purposes. 
Clinical records, including the subject’s name and other personal identifying information, and research data 
will be kept in secure storage at the New York State Psychiatric Institute. Information in paper format will 
be kept in locked files. Electronic data, including MRI images, will be protected by a firewall (programming 
that makes it virtually impossible to access the data from outside the New York State Psychiatric Institute) 
and by restricting access within the New York State Psychiatric Institute through use of a password known 

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only to authorized personnel. If information is transmitted electronically, it will be encrypted so that 
identifying information remains confidential. 
  All information that participants enter onto the iPod or iPhone will be encrypted and password-protected.  
If participants want to use their own iPhone for this study, they must agree to turn on the passcode 
(password) setting on their iPhone.  If they do not have an iPhone, or do not wish to turn on the passcode 
(password) setting, they may use our iPod instead. Information stored on the iPod/iPhone app is associated 
with an ID number, and not with participants' names or other identifying information.
The subject’s information will only be available to study research staff and other authorized individuals, 
including those at the New York State Psychiatric Institute, New York State and federal regulatory agencies 
such as the Food and Drug Administration who may review records as part of routine audits. There are also 
legal advocacy organizations that have authority under New York State law to have access to otherwise 
confidential subject records, although they cannot disclose this information without the subject’s consent.
 
The subject’s MRI will be interpreted and the results will be shared with the subject or physician who the 
subject may designate. The MRI report will be maintained as part of the clinical database at the Columbia 
Radiology MRI Center at the Neurological Institute along with the subject’s name and will be accessible to 
clinicians at the New York State Psychiatric Institute. The subject’s psychiatric diagnosis will not be a part 
of the report.
Will the study be conducted under a certificate of confidentiality?
No
Direct Benefits to Subjects  
Direct Benefits to Subjects
This study was not designed for the direct benefit of the participants. 
Participants will be offered three months of treatment visits with a psychiatrist for medication management 
at the conclusion of the tDCS procedures.
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.
Sample of patients with NSSI: 
For neuroimaging participants: Subjects who complete all imaging assessments will be compensated a 
total of $150. Subjects who do not complete all imaging assessments will receive a partial payment prorated 
based on their participation in the study ($50 for each fMRI scan and $50 for the tDCS administrations). 

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For participants without neuroimaging: Subjects who are enrolled without neuroimaging and complete 
all clinical assessments will receive $150.
Payment procedures are initiated upon subject’s completion of the study. Payment is in the form of a check, 
usually received in the mail about 4-6 weeks after completion of the study procedures. 
Sample of healthy volunteers for fMRI pilot:
Participants in the fMRI portion of the pilot will receive $50 for each of the two scans at the completion of 
the scan, for a total of $100.
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STATISTICAL ANALYSIS PLAN 
 
This is a double-blinded, randomized, sham-controlled pilot study examining the tolerability and 
eﬀec:veness of repeated administra:ons of tDCS over right vlPFC in trea:ng NSSI and its 
underlying neural correlates.  
 
Primary analyses on behavior and clinical outcomes will be conducted using linear mixed eﬀects 
models to account for repeated measures over :me and individual variability. All tests will be 
performed using two-sided alterna:ves with alpha=0.05. Ecological momentary assessment 
data will be evaluated using mixed eﬀects logis:c regression. BOLD imaging data will be 
analyzed using generalized linear models comparing pre- and post- interven:on neural 
responses to inclusion and exclusion trials during the Cyberball game. For all analyses, we will 
examine standard diagnos:c plots to iden:fy evidence of lack of model ﬁt, presence of outliers 
or overly inﬂuen:al points, etc., and take appropriate remedies as indicated (e.g., review source 
data of outliers, transform data, etc.). 
 
As this is a pilot study, addi:onal exploratory analyses will be conducted for hypothesis 
genera:ng purposes.