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Neuromodulation

Brain Stimulation for Suicide Risk (ENACTS Trial)

N/A

Recruiting

Led By Casey S Gilmore, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

are unable to provide informed consent as determined by the Modified Dysken Tool

have contraindications for tDCS (history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Summary

This trial tests a short-term treatment using a gentle brain treatment and exercises to help Veterans improve decision-making and reduce suicidal thoughts and behaviors.

Who is the study for?

This trial is for veterans currently in the MVAHCS Inpatient Psychiatric Unit who are at high risk of suicide, either screened positive on the VA's risk evaluation or attempted suicide within the last year. Participants must be able to complete tasks and have a smartphone. Those with seizure history, metal in their head, severe skin conditions on the scalp, involuntary commitment, inability to consent, or significant cognitive impairment cannot join.

What is being tested?

The ENACTS study tests a five-day intervention combining transcranial direct current stimulation (tDCS) with executive function training for veterans at high suicide risk. The goal is to see if this can reduce future suicidal behavior and improve quality of life. Participants will receive either active tDCS or a sham (placebo) version as part of the study.

What are the potential side effects?

While not explicitly listed here, common side effects of tDCS may include mild tingling, itching or discomfort at the electrode sites during stimulation; headache; fatigue; nausea; and insomnia.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to understand and agree to the study's requirements.

Select...

I don't have seizures, metal in my head, or scalp eczema.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intervention Acceptability

Recruitment Feasibility

Secondary study objectives

Groton Maze Task

NIH Quality of Life questionnaire

UPPS-P Impulsive Behavior scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).

Group II: Sham tDCSPlacebo Group1 Intervention

Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Transcranial Direct Current Stimulation (tDCS)

2020

N/A

~160

0 / 2Eligibility criteria met