Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Overseen by Jeffrey M Miller, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: New York State Psychiatric Institute

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jeffrey M Miller, MD

Principal Investigator

NYSPI

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

Treatment Details

Interventions

• Transcranial Direct Current Stimulation (Brain Stimulation)

Participant Groups

Group I: Discontinued prior to randomization Experimental Treatment 1 Intervention

Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study

Group II: active anodal tDCS to ventrolateral prefrontal cortex (VLPFC) Active Control 1 Intervention

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

Group III: sham anodal tDCS to VLPFC Placebo Group 1 Intervention

sham anodal tDCS to VLPFC Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Dr. Elizabeth B. Ford

New York State Psychiatric Institute

Chief Medical Officer since 2023

MD

Dr. Joshua A. Gordon

New York State Psychiatric Institute

Chief Executive Officer

MD, PhD in Neuroscience