Who is sponsoring NCT04244786?

NCT04244786 is sponsored by New York State Psychiatric Institute.

What drugs are being tested in NCT04244786?

Interventions in NCT04244786: Transcranial direct current stimulation, No intervention.

What condition does NCT04244786 study?

NCT04244786 studies 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.

Is NCT04244786 still recruiting?

NCT04244786 is currently completed. Last updated 3 July 2024.

Are results published for NCT04244786?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-03 · How we verify

NCT04244786

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Completed NA Results posted Last updated 3 July 2024

What this trial tests

NA trial testing Transcranial direct current stimulation in Self-Injurious Behavior in 13 participants. Completed in 29 July 2022.

Timeline

1 October 2019

Primary endpoint
29 July 2022

29 July 2022

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	13
Start date	1 October 2019
Primary completion	29 July 2022
Estimated completion	29 July 2022
Sites	1 location across United States

Drugs / interventions tested

Transcranial direct current stimulation
No intervention

Conditions studied

Self-Injurious Behavior — all drugs for Self-Injurious Behavior →
Self Harm — all drugs for Self Harm →
Self-injury — all drugs for Self-injury →
Self-inflicted Injury — all drugs for Self-inflicted Injury →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 60, any sex, with Self-Injurious Behavior or Self Harm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Social Processing (Cyberball) fMRI Task: fMRI Responses Primary · Pre-treatment (baseline) and post-treatment (up to 2 weeks)

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 spec

Parcel 29 (left dACC)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Pre-treatment	-621.4739585	± 819.58606846675
Sham Anodal tDCS to VLPFC: Post-treatment	-519.1597701	± 1187.3713291081
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment	-63.33972338	± 851.26348872338
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment	-396.4460666	± 779.73833545212
Discontinued Prior to Randomization	286.13477133333	± 1560.1228270282

Parcel 183 (right dACC)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Pre-treatment	-651.4402542	± 1422.0518670889
Sham Anodal tDCS to VLPFC: Post-treatment	-581.3360775	± 1419.4881641560
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment	-324.0953143	± 1101.3079494312
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment	-168.76175	± 679.73029181028
Discontinued Prior to Randomization	384.62016755555	± 2082.2972871030

Parcel 240 (right vlPFC)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Pre-treatment	-227.9885197	± 395.65696014195
Sham Anodal tDCS to VLPFC: Post-treatment	-203.971185	± 671.54324931238
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment	446.1573213	± 650.27267162975
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment	-287.2243125	± 839.18680962738
Discontinued Prior to Randomization	-588.4478376	± 1036.4740809912

Parcel 241 (right vlPFC)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Pre-treatment	-335.4290303	± 565.88946960588
Sham Anodal tDCS to VLPFC: Post-treatment	-215.3886576	± 1194.5755014134
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment	50.34725113	± 456.40817606524
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment	57.968314699999	± 956.33384050042
Discontinued Prior to Randomization	-482.2452623	± 1373.3034293132

Parcel 242 (right vlPFC)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Pre-treatment	-756.0566932	± 956.69043909054
Sham Anodal tDCS to VLPFC: Post-treatment	-297.5780364	± 1289.3740570339
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment	320.32500074999	± 986.09839303323
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment	48.925466799999	± 730.94081312280
Discontinued Prior to Randomization	-264.4217283	± 1149.8191589249

Parcel 247 (right AI)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Pre-treatment	-247.2044975	± 466.61315305963
Sham Anodal tDCS to VLPFC: Post-treatment	-495.6796714	± 758.72874358403
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment	-127.9602427	± 1163.6302170131
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment	-93.3563077	± 888.06111718986
Discontinued Prior to Randomization	-141.689008	± 1181.0573804472

Parcel 281 (right vlPFC)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Pre-treatment	-234.9502234	± 454.57709537062
Sham Anodal tDCS to VLPFC: Post-treatment	-229.4499879	± 706.92156796310
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment	220.64673762500	± 609.39673885219
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment	-137.8113024	± 437.9420888
Discontinued Prior to Randomization	-179.9291584	± 1004.2419972306

Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior Primary · 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 prompt

Strength of self-injury thoughts: baseline

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	1.2697	± 0.6952
Active Anodal tDCS to VLPFC	1.5285	± 1.0736

Strength of self-injury thoughts: during tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	1.1186	± 0.7094
Active Anodal tDCS to VLPFC	1.2294	± 0.9414

Strength of self-injury thoughts: post-tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.5667	± 0.8014
Active Anodal tDCS to VLPFC	1.38	± 0.9439

Duration of self-injury thoughts: baseline

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.9821	± 0.4538
Active Anodal tDCS to VLPFC	1.2479	± 1.1492

Duration of self-injury thoughts: during tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.6770	± 0.3366
Active Anodal tDCS to VLPFC	0.9503	± 0.9765

Duration of self-injury thoughts: post-tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.3333	± 0.4714
Active Anodal tDCS to VLPFC	1.2307	± 0.9196

Difficulty resisting self-injury thoughts: baseline

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	1.0587	± 0.6349
Active Anodal tDCS to VLPFC	1.0711	± 0.8945

Difficulty resisting self-injury thoughts: during tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	1.0636	± 0.8165
Active Anodal tDCS to VLPFC	0.9338	± 0.93

Self Injurious Thoughts and Behaviors Inventory Part 1 Primary · 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)

At their worst, how intense were your thoughts about engaging in self-harm? (sitbi 58)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Baseline	2.33	± 1.15
Sham Anodal tDCS to VLPFC: Post tDCS	2.67	± 1.15
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Baseline	2.67	± 0.58
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-tDCS	2.67	± 1.15

On average, how intense were your thoughts about engaging in self-harm? (sitbi 59)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Baseline	1.67	± 0.58
Sham Anodal tDCS to VLPFC: Post tDCS	2	± 1
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Baseline	1.67	± 0.58
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-tDCS	2.33	± 0.58

Ecological Momentary Assessment (EMA): NSSI Urges and Behavior Primary · 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 ind

Thoughts of self-injury: baseline

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.4453	± 0.2874
Active Anodal tDCS to VLPFC	0.4664	± 0.2274

Thoughts of self-injury: during tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.4084	± 0.2963
Active Anodal tDCS to VLPFC	0.3661	± 0.2166

Thoughts of self-injury: post-tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.2333	± 0.33
Active Anodal tDCS to VLPFC	0.3937	± 0.2379

Attempted to resist self-injury thoughts: baseline

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.3658	± 0.2531
Active Anodal tDCS to VLPFC	0.3146	± 0.2470

Attempted to resist self-injury thoughts: during tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.3509	± 0.2937
Active Anodal tDCS to VLPFC	0.2803	± 0.2644

Attempted to resist self-injury thoughts: post-tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.2	± 0.2828
Active Anodal tDCS to VLPFC	0.2071	± 0.2608

Self-harm behavior: baseline

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.0975	± 0.1082
Active Anodal tDCS to VLPFC	0.1759	± 0.1818

Self-harm behavior: during tDCS

Group	Value	95% CI
Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	0.1261	± 0.1615
Active Anodal tDCS to VLPFC	0.1073	± 0.1298

Self Injurious Thoughts and Behaviors Inventory Part 2 Primary · 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)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Baseline	4.33	± 2.52
Sham Anodal tDCS to VLPFC: Post tDCS	1.33	± 0.58
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Baseline	9.67	± 13.43
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-tDCS	1.33	± 2.31

Self Injurious Thoughts and Behaviors Inventory Part 3 Primary · 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)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Baseline	2.33	± 0.58
Sham Anodal tDCS to VLPFC: Post tDCS	2.33	± 1.15
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Baseline	3.33	± 0.58
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-tDCS	3.33	± 2.31

Self Injurious Thoughts and Behaviors Inventory Part 4 Primary · 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)

Likelihood of future self-harm thoughts (sitbi 61)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Baseline	4	± 0
Sham Anodal tDCS to VLPFC: Post tDCS	33	± 0.58
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Baseline	4	± 0
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-tDCS	4	± 0

Likelihood of future self-harm (sitbi 72)

Group	Value	95% CI
Sham Anodal tDCS to VLPFC: Baseline	4	± 0
Sham Anodal tDCS to VLPFC: Post tDCS	3.33	± 0.58
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Baseline	3.67	± 0.58
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-tDCS	3.67	± 0.58

tDCS Adverse Effects Questionnaire Secondary · 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 durin

Headache

Group	Value	95% CI
Sham Anodal tDCS to VLPFC	2
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	2

Neck Pain

Group	Value	95% CI
Sham Anodal tDCS to VLPFC	0
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	1

Scalp pain

Group	Value	95% CI
Sham Anodal tDCS to VLPFC	1
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	1

Tingling

Group	Value	95% CI
Sham Anodal tDCS to VLPFC	3
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	2

Itching

Group	Value	95% CI
Sham Anodal tDCS to VLPFC	3
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	2

Burning sensation

Group	Value	95% CI
Sham Anodal tDCS to VLPFC	3
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	3

Skin Redness

Group	Value	95% CI
Sham Anodal tDCS to VLPFC	3
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	3

Sleepiness

Group	Value	95% CI
Sham Anodal tDCS to VLPFC	3
Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sham Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)

Serious: 0/3 (0%)

Deaths: 0/3

Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC)

Serious: 0/3 (0%)

Deaths: 0/3

Discontinued Prior to Randomization

Serious: 2/7 (29%)

Deaths: 0/7

Serious adverse events (2 terms)

Reaction	System	Sham Anodal tDCS to Ventro…	Active Anodal tDCS to Vent…	Discontinued Prior to Rand…
Hospitalization	Gastrointestinal disorders	—	—	—
Suicide Attempt	Psychiatric disorders	—	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Sham Anodal tDCS to Ventro…	Active Anodal tDCS to Vent…	Discontinued Prior to Rand…
Tingling	Skin and subcutaneous tissue disorders	—	—	—
Itching	Skin and subcutaneous tissue disorders	—	—	—
Burning Sensation	Skin and subcutaneous tissue disorders	—	—	—
Skin redness	Skin and subcutaneous tissue disorders	—	—	—
Sleepiness	Nervous system disorders	—	—	—
Trouble concentrating	Nervous system disorders	—	—	—
Acute Mood Change	Psychiatric disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Neck Pain	Musculoskeletal and connective tissue disorders	—	—	—
Scalp Pain	Skin and subcutaneous tissue disorders	—	—	—
Other: Heart palpitations	Cardiac disorders	—	—	—
Other: Psychomotor agitation	Psychiatric disorders	—	—	—
Other: Derealization	Psychiatric disorders	—	—	—
Other: Pressure	Product Issues	—	—	—

Most-reported serious reactions: Hospitalization, Suicide Attempt.

Data from ClinicalTrials.gov NCT04244786 adverse events section.

Sponsor's own description

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). Individuals who engage in frequent NSSI will be randomized to 12 administrations of an active vs. inactive form of tDCS, paired with an Attention Training Technique task, over a two-week period. Functional MRI may be performed before and after this two week period. NSSI urges and behaviors will be monitored before, during, and after the period of tDCS administrations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Psychosocial interventions for self-harm in adults.
Witt KG, Hetrick SE, Rajaram G, Hazell P, et al · · 2021 · cited 79× · PMID 33884617 · DOI 10.1002/14651858.cd013668.pub2

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04244786 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by New York State Psychiatric Institute
Last refreshed: 3 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04244786.

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