N/A
N=13
Treating Self Injurious Behavior: A Novel Brain Stimulation Approach
Self-Injurious Behavior · Self Harm · Self-injury · Self-inflicted Injury · Self Injurious Behavior Without Suicidal Intent
Bottom Line
View on ClinicalTrials.gov: NCT04244786 ↗Enrolled (actual)
13
Serious AEs
15.4%
Results posted
Jul 2024
Primary outcome: Primary: Social Processing (Cyberball) fMRI Task: fMRI Responses — -621.4739585; -519.1597701; -63.33972338; -396.4460666 beta-weight
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial direct current stimulation (Device); No intervention (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Social Processing (Cyberball) fMRI Task: fMRI Responses |
-621.4739585; -519.1597701; -63.33972338; -396.4460666; 286.13477133333; -651.4402542 | — |
| PRIMARY Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior |
1.2697; 1.5285; 1.1186; 1.2294; 0.5667; 1.38 | — |
| PRIMARY Self Injurious Thoughts and Behaviors Inventory Part 1 |
2.33; 2.67; 2.67; 2.67; 1.67; 2 | — |
| PRIMARY Ecological Momentary Assessment (EMA): NSSI Urges and Behavior |
0.4453; 0.4664; 0.4084; 0.3661; 0.2333; 0.3937 | — |
| PRIMARY Self Injurious Thoughts and Behaviors Inventory Part 2 |
4.33; 1.33; 9.67; 1.33 | — |
| PRIMARY Self Injurious Thoughts and Behaviors Inventory Part 3 |
2.33; 2.33; 3.33; 3.33 | — |
| PRIMARY Self Injurious Thoughts and Behaviors Inventory Part 4 |
4; 33; 4; 4; 4; 3.33 | — |
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.
Eligibility Criteria
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
- Unstable medical conditions based on medical history or physical examination
- Current psychotic disorder, mania, hypomania, intellectual disability
- Dermatologic condition resulting in non-intact skin on the scalp
- Significant suicidal ideation with a plan and intent that cannot be managed safely as an outpatient
- Pregnancy, currently lactating, or planning to conceive during the course of study participation.
- A neurological disease or prior head trauma with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score ≥ 1.5 standard deviations below the mean on the Trailmaking A&B will be excluded from study participation.
- Current alcohol or substance use disorder that is severe according to DSM-V criteria
- Individuals who initiated or increased the dose of concurrent psychiatric medications (including antidepressants, anxiolytics, antipsychotic medications, mood stabilizers, and benzodiazepines) within two weeks prior to enrollment
- Individuals who initiated psychotherapy within two weeks prior to enrollment
- Current seizure disorder.
- Use of anticonvulsant medications that target the GABA system (e.g., gabapentin).
- Individuals currently using benzodiazepines who are unwilling or unable to refrain from the use of benzodiazepine medications for at least 72 hours before the first tDCS session and throughout the duration of the 2-week tDCS intervention.
- Metal implants or paramagnetic objects contained within the body (including heart pacemaker, shrapnel, or surgical prostheses) which may present a risk to the subject or interfere with the MRI scan, according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects," F.G. Shellock, Lippincott Williams and Wilkins NY 2001. Additionally transdermal patches will be removed during the MR study at the discretion of the investigator.
- Claustrophobia significant enough to interfere with MRI scanning
- Weight that exceeds 325 lbs or inability to fit into MRI scanner
- Suicide attempt within the past 3 months
- Serious self-harm resulting in hospitalization within the past 3 months.
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Data sourced from ClinicalTrials.gov (NCT04244786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.