Trials / Completed

CompletedNCT04244786

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 13 (actual)

Sponsor: New York State Psychiatric Institute · Academic / Other
Sex: All
Age: 18 Years – 60 Years
Healthy volunteers: Not accepted

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.

Detailed 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). NSSI is the deliberate attempt to harm oneself, most often through cutting or burning, without suicidal intent. NSSI is a maladaptive emotion-regulation strategy often triggered by negative emotions, especially those involving feelings of rejection. tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes. Several studies have demonstrated its effectiveness in treating an array of conditions, depending on electrode placement, including depression and chronic pain. tDCS may also facilitate adaptive emotion regulation; researchers have also successfully used tDCS to reduce negative emotions and aggressive responses to social rejection. The investigators therefore seek to explore tDCS as a potential treatment for NSSI. This pilot feasibility study seeks 1) to examine how tDCS is tolerated in a sample of individuals who engage in frequent NSSI; 2) to gather pilot data regarding changes in emotional and neural responses during a social task after a series of tDCS sessions in this clinical population of individuals who engage in NSSI; 3) to gather pilot data on the effects of tDCS on NSSI behaviors and urges. The investigators seek to recruit a sample of 22 individuals who engage in frequent NSSI to complete all study procedures. Individuals will be randomized to receive active- or sham-tDCS for two twenty-minute applications on each of six alternating sessions over approximately two weeks for a total of 12 tDCS administrations, each paired with an Attention Training Task. Functional MRI (fMRI) may be performed at baseline and again after the completion of 12 applications of tDCS. Subjects' NSSI and urges to engage in NSSI will be recorded for four weeks in real-time, using an iPod- based system that reminds subjects to stop at certain times during the day to record their thoughts, feelings, and behaviors. This will allow measurement of NSSI urges and behaviors for one week before, two weeks during, and one week after the tDCS intervention. The long-term goal of this study is to identify a novel form of treatment for NSSI and to better understand NSSI pathophysiology.

Conditions

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation	tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes.
OTHER	No intervention	No intervention for participants who discontinued prior to randomization

Timeline

Start date: 2019-10-01
Primary completion: 2022-07-29
Completion: 2022-07-29
First posted: 2020-01-28
Last updated: 2024-07-03
Results posted: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT04244786. Inclusion in this directory is not an endorsement.