Trial Outcomes & Findings for Treating Self Injurious Behavior: A Novel Brain Stimulation Approach (NCT NCT04244786)

Last Updated: 2024-07-03

Results Overview

The Cyberball task is a task used during functional MRI scanning. During the task, individuals play a virtual ball-tossing game, playing catch with two computer avatars, and have a social exclusion experience when the avatars stop tossing the ball to them. The outcome measure is a subtraction of a measure of brain activity (fMRI BOLD signal) during portions of the task when the individual is included in the virtual ball-tossing game as compared to periods when the individual is excluded (i.e. fMRI BOLD signal inclusion periods - fMRI BOLD signal exclusion periods). This is quantified in 7 specific brain regions specified in the table below. dACC = dorsal anterior cingulate. vlPFC = ventrolateral prefrontal cortex. AI = anterior insula. The unit of measurement is a beta-weight from a general linear model (a statistical model) and a higher value reflects greater activity in a given brain region during experiences of social exclusion as compared to social inclusion.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

Pre-treatment (baseline) and post-treatment (up to 2 weeks)

Results posted on

2024-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) active anodal tDCS to ventrolateral prefrontal cortex (VLPFC). 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions Transcranial direct current stimulation: 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.	Sham Anodal tDCS to VLPFC sham anodal tDCS to VLPFC Identical electrode montage, 12 administrations of sham tDCS over 6 sessions. Transcranial direct current stimulation: 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.	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study No intervention: No intervention for participants who discontinued prior to randomization
Overall Study STARTED	3	3	7
Overall Study COMPLETED	3	3	0
Overall Study NOT COMPLETED	0	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) active anodal tDCS to ventrolateral prefrontal cortex (VLPFC). 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions Transcranial direct current stimulation: 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.	Sham Anodal tDCS to VLPFC sham anodal tDCS to VLPFC Identical electrode montage, 12 administrations of sham tDCS over 6 sessions. Transcranial direct current stimulation: 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.	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study No intervention: No intervention for participants who discontinued prior to randomization
Overall Study Adverse Event	0	0	2
Overall Study Withdrawal by Subject	0	0	5

Baseline Characteristics

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) n=3 Participants active anodal tDCS to ventrolateral prefrontal cortex (VLPFC). 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions Transcranial direct current stimulation: 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.	Sham Anodal tDCS to VLPFC n=3 Participants sham anodal tDCS to VLPFC Identical electrode montage, 12 administrations of sham tDCS over 6 sessions. Transcranial direct current stimulation: 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.	Discontinued Prior to Randomization n=7 Participants Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study No intervention: No intervention for participants who discontinued prior to randomization	Total n=13 Participants Total of all reporting groups
Age, Continuous	24.7 years STANDARD_DEVIATION 3.5 • n=5 Participants	20 years STANDARD_DEVIATION 1 • n=7 Participants	25.1 years STANDARD_DEVIATION 6.0 • n=5 Participants	23.8 years STANDARD_DEVIATION 5.0 • n=4 Participants
Sex/Gender, Customized Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Sex/Gender, Customized Male	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Sex/Gender, Customized Non-Binary	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants	13 participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-treatment (baseline) and post-treatment (up to 2 weeks)

Outcome measures

Outcome measures
Measure	Sham Anodal tDCS to VLPFC: Pre-treatment n=2 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Sham Anodal tDCS to VLPFC: Post-treatment n=2 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment n=2 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment n=2 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6 sessions	Discontinued Prior to Randomization n=2 Participants Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study.
Social Processing (Cyberball) fMRI Task: fMRI Responses Parcel 29 (left dACC)	-621.4739585 beta-weight Standard Deviation 819.58606846675	-519.1597701 beta-weight Standard Deviation 1187.3713291081	-63.33972338 beta-weight Standard Deviation 851.26348872338	-396.4460666 beta-weight Standard Deviation 779.73833545212	286.13477133333 beta-weight Standard Deviation 1560.1228270282
Social Processing (Cyberball) fMRI Task: fMRI Responses Parcel 183 (right dACC)	-651.4402542 beta-weight Standard Deviation 1422.0518670889	-581.3360775 beta-weight Standard Deviation 1419.4881641560	-324.0953143 beta-weight Standard Deviation 1101.3079494312	-168.76175 beta-weight Standard Deviation 679.73029181028	384.62016755555 beta-weight Standard Deviation 2082.2972871030
Social Processing (Cyberball) fMRI Task: fMRI Responses Parcel 240 (right vlPFC)	-227.9885197 beta-weight Standard Deviation 395.65696014195	-203.971185 beta-weight Standard Deviation 671.54324931238	446.1573213 beta-weight Standard Deviation 650.27267162975	-287.2243125 beta-weight Standard Deviation 839.18680962738	-588.4478376 beta-weight Standard Deviation 1036.4740809912
Social Processing (Cyberball) fMRI Task: fMRI Responses Parcel 241 (right vlPFC)	-335.4290303 beta-weight Standard Deviation 565.88946960588	-215.3886576 beta-weight Standard Deviation 1194.5755014134	50.34725113 beta-weight Standard Deviation 456.40817606524	57.968314699999 beta-weight Standard Deviation 956.33384050042	-482.2452623 beta-weight Standard Deviation 1373.3034293132
Social Processing (Cyberball) fMRI Task: fMRI Responses Parcel 242 (right vlPFC)	-756.0566932 beta-weight Standard Deviation 956.69043909054	-297.5780364 beta-weight Standard Deviation 1289.3740570339	320.32500074999 beta-weight Standard Deviation 986.09839303323	48.925466799999 beta-weight Standard Deviation 730.94081312280	-264.4217283 beta-weight Standard Deviation 1149.8191589249
Social Processing (Cyberball) fMRI Task: fMRI Responses Parcel 247 (right AI)	-247.2044975 beta-weight Standard Deviation 466.61315305963	-495.6796714 beta-weight Standard Deviation 758.72874358403	-127.9602427 beta-weight Standard Deviation 1163.6302170131	-93.3563077 beta-weight Standard Deviation 888.06111718986	-141.689008 beta-weight Standard Deviation 1181.0573804472
Social Processing (Cyberball) fMRI Task: fMRI Responses Parcel 281 (right vlPFC)	-234.9502234 beta-weight Standard Deviation 454.57709537062	-229.4499879 beta-weight Standard Deviation 706.92156796310	220.64673762500 beta-weight Standard Deviation 609.39673885219	-137.8113024 beta-weight Standard Deviation 437.9420888	-179.9291584 beta-weight Standard Deviation 1004.2419972306

PRIMARY outcome

Timeframe: One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)

EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Scores, coded on a scale from 1-5, are averaged across all prompts during the time period (baseline, during tDCS, post-tDCS). A higher score indicates more severe symptoms except for "success at resisting thoughts", which is reverse-coded.

Outcome measures

Outcome measures
Measure	Sham Anodal tDCS to VLPFC: Pre-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Sham Anodal tDCS to VLPFC: Post-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6 sessions	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study.
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Strength of self-injury thoughts: baseline	1.2697 Average score on a scale Standard Deviation 0.6952	1.5285 Average score on a scale Standard Deviation 1.0736	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Strength of self-injury thoughts: during tDCS	1.1186 Average score on a scale Standard Deviation 0.7094	1.2294 Average score on a scale Standard Deviation 0.9414	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Strength of self-injury thoughts: post-tDCS	0.5667 Average score on a scale Standard Deviation 0.8014	1.38 Average score on a scale Standard Deviation 0.9439	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Duration of self-injury thoughts: baseline	0.9821 Average score on a scale Standard Deviation 0.4538	1.2479 Average score on a scale Standard Deviation 1.1492	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Duration of self-injury thoughts: during tDCS	0.6770 Average score on a scale Standard Deviation 0.3366	0.9503 Average score on a scale Standard Deviation 0.9765	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Duration of self-injury thoughts: post-tDCS	0.3333 Average score on a scale Standard Deviation 0.4714	1.2307 Average score on a scale Standard Deviation 0.9196	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Difficulty resisting self-injury thoughts: baseline	1.0587 Average score on a scale Standard Deviation 0.6349	1.0711 Average score on a scale Standard Deviation 0.8945	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Difficulty resisting self-injury thoughts: during tDCS	1.0636 Average score on a scale Standard Deviation 0.8165	0.9338 Average score on a scale Standard Deviation 0.93	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Difficulty resisting self-injury thoughts: post-tDCS	0.5667 Average score on a scale Standard Deviation 0.8014	0.7879 Average score on a scale Standard Deviation 1.0654	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Success at resisting self-injury thoughts: baseline	1.0774 Average score on a scale Standard Deviation 0.8346	0.8344 Average score on a scale Standard Deviation 0.5786	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Success at resisting self-injury thoughts: during tDCS	1.0476 Average score on a scale Standard Deviation 0.8987	0.7404 Average score on a scale Standard Deviation 0.6601	—	—	—
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Success at resisting self-injury thoughts: post-tDCS	0.6667 Average score on a scale Standard Deviation 0.9428	0.4444 Average score on a scale Standard Deviation 0.5092	—	—	—

PRIMARY outcome

Timeframe: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)

Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported in this table: Sitbi 58: At their worst, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe) sitbi 59: On average, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe)

Outcome measures

Outcome measures
Measure	Sham Anodal tDCS to VLPFC: Pre-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Sham Anodal tDCS to VLPFC: Post-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment n=3 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment n=3 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6 sessions	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study.
Self Injurious Thoughts and Behaviors Inventory Part 1 At their worst, how intense were your thoughts about engaging in self-harm? (sitbi 58)	2.33 score on a scale Standard Deviation 1.15	2.67 score on a scale Standard Deviation 1.15	2.67 score on a scale Standard Deviation 0.58	2.67 score on a scale Standard Deviation 1.15	—
Self Injurious Thoughts and Behaviors Inventory Part 1 On average, how intense were your thoughts about engaging in self-harm? (sitbi 59)	1.67 score on a scale Standard Deviation 0.58	2 score on a scale Standard Deviation 1	1.67 score on a scale Standard Deviation 0.58	2.33 score on a scale Standard Deviation 0.58	—

PRIMARY outcome

Timeframe: One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)

EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Items refer to the proportion of survey responses in which an individual endorsed the given thought or behavior or attempted to resist NSSI thoughts since the previous response (0 to 1), with "yes" scored as 1 and "no" scored as a zero.

Outcome measures

Outcome measures
Measure	Sham Anodal tDCS to VLPFC: Pre-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Sham Anodal tDCS to VLPFC: Post-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6 sessions	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study.
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Thoughts of self-injury: baseline	0.4453 Proportion of prompts Standard Deviation 0.2874	0.4664 Proportion of prompts Standard Deviation 0.2274	—	—	—
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Thoughts of self-injury: during tDCS	0.4084 Proportion of prompts Standard Deviation 0.2963	0.3661 Proportion of prompts Standard Deviation 0.2166	—	—	—
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Thoughts of self-injury: post-tDCS	0.2333 Proportion of prompts Standard Deviation 0.33	0.3937 Proportion of prompts Standard Deviation 0.2379	—	—	—
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Attempted to resist self-injury thoughts: baseline	0.3658 Proportion of prompts Standard Deviation 0.2531	0.3146 Proportion of prompts Standard Deviation 0.2470	—	—	—
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Attempted to resist self-injury thoughts: during tDCS	0.3509 Proportion of prompts Standard Deviation 0.2937	0.2803 Proportion of prompts Standard Deviation 0.2644	—	—	—
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Attempted to resist self-injury thoughts: post-tDCS	0.2 Proportion of prompts Standard Deviation 0.2828	0.2071 Proportion of prompts Standard Deviation 0.2608	—	—	—
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Self-harm behavior: baseline	0.0975 Proportion of prompts Standard Deviation 0.1082	0.1759 Proportion of prompts Standard Deviation 0.1818	—	—	—
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Self-harm behavior: during tDCS	0.1261 Proportion of prompts Standard Deviation 0.1615	0.1073 Proportion of prompts Standard Deviation 0.1298	—	—	—
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Self-harm behavior: post-tDCS	0.1 Proportion of prompts Standard Deviation 0.1414	0.0967 Proportion of prompts Standard Deviation 0.1343	—	—	—

PRIMARY outcome

Timeframe: pre-treatment (baseline) and post-treatment (up to 2 weeks)

Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table: sitbi 68: How many times \[did you self-injure\] in the past week? (number entered, minimum = 0, maximum = no limit)

Outcome measures

Outcome measures
Measure	Sham Anodal tDCS to VLPFC: Pre-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Sham Anodal tDCS to VLPFC: Post-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment n=3 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment n=3 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6 sessions	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study.
Self Injurious Thoughts and Behaviors Inventory Part 2	4.33 Number of events Standard Deviation 2.52	1.33 Number of events Standard Deviation 0.58	9.67 Number of events Standard Deviation 13.43	1.33 Number of events Standard Deviation 2.31	—

PRIMARY outcome

Timeframe: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)

Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table: sitbi 60: When you have had these thoughts: how long have they usually lasted? (0: 0 seconds to 6: more than 2 days)

Outcome measures

Outcome measures
Measure	Sham Anodal tDCS to VLPFC: Pre-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Sham Anodal tDCS to VLPFC: Post-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment n=3 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment n=3 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6 sessions	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study.
Self Injurious Thoughts and Behaviors Inventory Part 3	2.33 score on a scale Standard Deviation 0.58	2.33 score on a scale Standard Deviation 1.15	3.33 score on a scale Standard Deviation 0.58	3.33 score on a scale Standard Deviation 2.31	—

PRIMARY outcome

Timeframe: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)

Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported here: sitbi 61: What is the likelihood you will have thoughts about engaging in NSSI in the future? (0: very unlikely to 4: very likely) sitbi 72: What do you think is the likelihood you will engage in NSSI in the future? (0: very unlikely to 4: very likely)

Outcome measures

Outcome measures
Measure	Sham Anodal tDCS to VLPFC: Pre-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Sham Anodal tDCS to VLPFC: Post-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment n=3 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment n=3 Participants 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6 sessions	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study.
Self Injurious Thoughts and Behaviors Inventory Part 4 Likelihood of future self-harm thoughts (sitbi 61)	4 score on a scale Standard Deviation 0	33 score on a scale Standard Deviation 0.58	4 score on a scale Standard Deviation 0	4 score on a scale Standard Deviation 0	—
Self Injurious Thoughts and Behaviors Inventory Part 4 Likelihood of future self-harm (sitbi 72)	4 score on a scale Standard Deviation 0	3.33 score on a scale Standard Deviation 0.58	3.67 score on a scale Standard Deviation 0.58	3.67 score on a scale Standard Deviation 0.58	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Administered after each (12) tDCS session over 6 days

A questionnaire to evaluate side-effects related to tDCS administration. This questionnaire asks about the presence and severity of possible side-effects of tDCS procedures, and was recently published as a gold-standard tool for this purpose: Aparício LVM, Guarienti F, Razza LB, Carvalho AF, Fregni F, Brunoni AR. A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Brain Stimul. 2016 Oct;9(5):671-81. This is an 11-item scale, that asks about the occurrence and severity of a range of possible side-effects during or after tDCS administration. Each side-effect can be rated as absent, mild, moderate, or severe. Summary data regarding the number of participants who endorsed a listed side-effect from the scale during at least one tDCS administration are presented here. Each participant was asked about the presence and severity of all listed side-effects after each administration of tDCS.

Outcome measures

Outcome measures
Measure	Sham Anodal tDCS to VLPFC: Pre-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Sham Anodal tDCS to VLPFC: Post-treatment n=3 Participants Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6 sessions	Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study.
tDCS Adverse Effects Questionnaire Headache	2 Participants	2 Participants	—	—	—
tDCS Adverse Effects Questionnaire Neck Pain	0 Participants	1 Participants	—	—	—
tDCS Adverse Effects Questionnaire Scalp pain	1 Participants	1 Participants	—	—	—
tDCS Adverse Effects Questionnaire Tingling	3 Participants	2 Participants	—	—	—
tDCS Adverse Effects Questionnaire Itching	3 Participants	2 Participants	—	—	—
tDCS Adverse Effects Questionnaire Burning sensation	3 Participants	3 Participants	—	—	—
tDCS Adverse Effects Questionnaire Skin Redness	3 Participants	3 Participants	—	—	—
tDCS Adverse Effects Questionnaire Sleepiness	3 Participants	2 Participants	—	—	—
tDCS Adverse Effects Questionnaire Trouble concentrating	3 Participants	3 Participants	—	—	—
tDCS Adverse Effects Questionnaire Acute mood change	0 Participants	3 Participants	—	—	—
tDCS Adverse Effects Questionnaire Other	1 Participants	2 Participants	—	—	—

Adverse Events

Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Discontinued Prior to Randomization

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) n=3 participants at risk Identical electrode montage, 12 administrations of sham tDCS over 6 sessions. Transcranial direct current stimulation: 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.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) n=3 participants at risk active anodal tDCS to ventrolateral prefrontal cortex (VLPFC). 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions Transcranial direct current stimulation: 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.	Discontinued Prior to Randomization n=7 participants at risk Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study No intervention: No intervention for participants who discontinued prior to randomization
Gastrointestinal disorders Hospitalization	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	14.3% 1/7 • Number of events 1 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Psychiatric disorders Suicide Attempt	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	14.3% 1/7 • Number of events 1 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.

Other adverse events

Other adverse events
Measure	Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) n=3 participants at risk Identical electrode montage, 12 administrations of sham tDCS over 6 sessions. Transcranial direct current stimulation: 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.	Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) n=3 participants at risk active anodal tDCS to ventrolateral prefrontal cortex (VLPFC). 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions Transcranial direct current stimulation: 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.	Discontinued Prior to Randomization n=7 participants at risk Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study No intervention: No intervention for participants who discontinued prior to randomization
Nervous system disorders Headache	66.7% 2/3 • Number of events 13 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	66.7% 2/3 • Number of events 15 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	33.3% 1/3 • Number of events 2 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Skin and subcutaneous tissue disorders Scalp Pain	33.3% 1/3 • Number of events 1 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	33.3% 1/3 • Number of events 1 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Skin and subcutaneous tissue disorders Tingling	100.0% 3/3 • Number of events 12 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	66.7% 2/3 • Number of events 15 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Skin and subcutaneous tissue disorders Itching	100.0% 3/3 • Number of events 17 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	66.7% 2/3 • Number of events 16 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Skin and subcutaneous tissue disorders Burning Sensation	100.0% 3/3 • Number of events 26 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	100.0% 3/3 • Number of events 32 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Skin and subcutaneous tissue disorders Skin redness	100.0% 3/3 • Number of events 35 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	100.0% 3/3 • Number of events 31 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Nervous system disorders Sleepiness	100.0% 3/3 • Number of events 25 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	66.7% 2/3 • Number of events 15 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Nervous system disorders Trouble concentrating	100.0% 3/3 • Number of events 25 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	100.0% 3/3 • Number of events 29 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Psychiatric disorders Acute Mood Change	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	100.0% 3/3 • Number of events 4 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Cardiac disorders Other: Heart palpitations	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	33.3% 1/3 • Number of events 2 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Psychiatric disorders Other: Psychomotor agitation	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	33.3% 1/3 • Number of events 3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Psychiatric disorders Other: Derealization	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	33.3% 1/3 • Number of events 1 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
Product Issues Other: Pressure	33.3% 1/3 • Number of events 1 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/3 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.	0.00% 0/7 • For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks. Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.

Additional Information

Jeffrey Miller

New York State Psychiatric Institute

Phone: 646-774-7613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place