Brain Stimulation for Suicide Risk
(ENACTS Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for reducing suicide risk?
Is transcranial direct current stimulation (tDCS) safe for humans?
Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no reports of serious adverse effects in over 33,200 sessions and 1,000 subjects, including vulnerable populations. Common mild side effects include itching, tingling, and headaches, but these are not significantly different from those experienced with placebo treatments.678910
How is the treatment Active Transcranial Direct Current Stimulation (tDCS) different from other treatments for suicide risk?
Active Transcranial Direct Current Stimulation (tDCS) is unique because it is a non-invasive treatment that uses electrical currents to stimulate specific areas of the brain, which may help improve mood and reduce symptoms of depression. Unlike traditional treatments like medication or talk therapy, tDCS directly targets brain activity and can be administered at home, although safety concerns need to be addressed.1391112
Research Team
Casey S Gilmore, PhD
Principal Investigator
Minneapolis VA Health Care System, Minneapolis, MN
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 10 sessions of cognitive training concurrent with either active or sham transcranial direct current stimulation over five days
Follow-up
Participants are monitored for changes in impulsive behavior, executive function, and quality of life
Treatment Details
Interventions
- Active Transcranial Direct Current Stimulation (tDCS)
- Sham Transcranial Direct Current Stimulation (tDCS)
Active Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union for the following indications:
- Treatment-resistant depression
- Chronic pain
- Cognitive enhancement
- Research purposes including suicide prevention
- Treatment-resistant depression
- Chronic pain
- Cognitive enhancement
- Research purposes including neurological and psychiatric conditions
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor