← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

ENACTS Trial Summary

This trial is testing whether a five-day brain stimulation intervention can help reduce suicide risk in high-risk patients.

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.Check my eligibility

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.See study design

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.

ENACTS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention Acceptability

Recruitment Feasibility

Secondary outcome measures

Groton Maze Task

NIH Quality of Life questionnaire

UPPS-P Impulsive Behavior scale

ENACTS 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,246 Total Patients Enrolled

39 Trials studying Suicide

6,508 Patients Enrolled for Suicide

Casey S Gilmore, PhDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN

Media Library

Active Transcranial Direct Current Stimulation (tDCS) (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05231213 — N/A

Suicide Research Study Groups: Active tDCS, Sham tDCS

Suicide Clinical Trial 2023: Active Transcranial Direct Current Stimulation (tDCS) Highlights & Side Effects. Trial Name: NCT05231213 — N/A

Active Transcranial Direct Current Stimulation (tDCS) (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05231213 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor recruiting participants?

"Affirmative. Medical data hosted on clinicaltrials.gov confirms that this trial, which was originally posted on July 1st 2022, is actively enrolling patients. For the study to be successful 38 participants need to be recruited from 1 facility."

Answered by AI

Is there an opportunity to take part in this medical experiment?

"For this study, 38 individuals aged 18-75 with a history of suicidal ideation are required. These participants must also have been recently admitted to the MVAHCS Inpatient Psychiatric Unit, present an increased risk for suicide (determined by completion of the VA Comprehensive Suicide Risk Evaluation at intake or prior attempts in 12 months), and be able to participate in all assignments and procedures."

Answered by AI

Is it necessary to meet a specified age cutoff in order to participate in this research?

"According to the criteria for inclusion, only individuals between 18 and 75 can be considered. There are 62 trials specifically designed for those under 18 years old and 122 applicable to patients over 65."

Answered by AI

What is the participant enrollment count for this research study?

"Affirmative. Clinicaltrials.gov provides evidence that the medical study, which was posted on July 1st 2022 is still actively recruiting patients. 38 individuals are required to be enrolled from one clinical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)

2022. "Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05231213.