CompletedNot Applicable

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

United States13 participantsStarted 2019-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-60
. Frequent current NSSI (including cutting in which the skin is broken; self-hitting in which there is bruising; or burning in which there is evidence of a burn. Will not enroll if skin-picking or scratching is the only form of self-injury): has engaged in ≥2 episodes of NSSI in the two months prior to enrollment
. Capacity to provide informed consent
. If carries a diagnosis of bipolar I or II disorder, taking or willing to begin a therapeutic dose of a mood stabilizer.
. Normal hearing.
. Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. -

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Social Processing (Cyberball) fMRI Task: fMRI Responses

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

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

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

Self Injurious Thoughts and Behaviors Inventory Part 1

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

Ecological Momentary Assessment (EMA): NSSI Urges and Behavior

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

Self Injurious Thoughts and Behaviors Inventory Part 2

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

Self Injurious Thoughts and Behaviors Inventory Part 3

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

Trial details

NCT IDNCT04244786

SponsorNew York State Psychiatric Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-29

Results submitted2024-01-29

View on ClinicalTrials.gov More Self-Injurious Behavior trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-60
. Frequent current NSSI (including cutting in which the skin is broken; self-hitting in which there is bruising; or burning in which there is evidence of a burn. Will not enroll if skin-picking or scratching is the only form of self-injury): has engaged in ≥2 episodes of NSSI in the two months prior to enrollment
. Capacity to provide informed consent
. If carries a diagnosis of bipolar I or II disorder, taking or willing to begin a therapeutic dose of a mood stabilizer.
. Normal hearing.
. Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. -

Exclusion criteria

What they're measuring

Social Processing (Cyberball) fMRI Task: fMRI Responses

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

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

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

Self Injurious Thoughts and Behaviors Inventory Part 1

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

Ecological Momentary Assessment (EMA): NSSI Urges and Behavior

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

Self Injurious Thoughts and Behaviors Inventory Part 2

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

Self Injurious Thoughts and Behaviors Inventory Part 3

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