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 range18 Years ā 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age 18-60
ā. 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 ā„2 episodes of NSSI in the two months prior to enrollment
ā. Capacity to provide informed consent
ā. If carries a diagnosis of bipolar I or II disorder, taking or willing to begin a therapeutic dose of a mood stabilizer.
ā. Normal hearing.
ā. Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. -
Exclusion criteria
ā. Unstable medical conditions based on medical history or physical examination
ā. Current psychotic disorder, mania, hypomania, intellectual disability
ā. Dermatologic condition resulting in non-intact skin on the scalp
What they're measuring
1
Social Processing (Cyberball) fMRI Task: fMRI Responses
Timeframe: Pre-treatment (baseline) and post-treatment (up to 2 weeks)
2
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)
3
Self Injurious Thoughts and Behaviors Inventory Part 1
Timeframe: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
4
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)
5
Self Injurious Thoughts and Behaviors Inventory Part 2
Timeframe: pre-treatment (baseline) and post-treatment (up to 2 weeks)
6
Self Injurious Thoughts and Behaviors Inventory Part 3
Timeframe: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
7
Self Injurious Thoughts and Behaviors Inventory Part 4
Timeframe: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
ā. Significant suicidal ideation with a plan and intent that cannot be managed safely as an outpatient
ā. Pregnancy, currently lactating, or planning to conceive during the course of study participation.
ā. A neurological disease or prior head trauma with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score ā„ 1.5 standard deviations below the mean on the Trailmaking A\&B will be excluded from study participation.
ā. Current alcohol or substance use disorder that is severe according to DSM-V criteria
ā. 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