SuicideENACTSNCT05231213
Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Suicide and Impulsivity, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Impaired executive function, such as impaired decision making and impulsivity, has been identified as an important contributor to the transition from suicidal ideation to suicide attempt. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Suicide, Impulsivity
- What is being tested?
- Active Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 31 Mar 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently admitted into the MVAHCS Inpatient Psychiatric Unit
- at a heightened risk for suicide (defined as a positive screen on the VA Comprehensive Suicide Risk Evaluation (CSRE) at intake and/or a suicide attempt within the previous 12 months)
- able to complete procedures and tasks
Who cannot join
- are unable to provide informed consent as determined by the Modified Dysken Tool
- have moderate/severe cognitive impairment as determined by the Mini-Mental State Examination (score 27)
- have contraindications for tDCS (history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp)
- do not have a smartphone or device running Android or Apple iOS with which to download the mPRO EMA app
- have been involuntarily committed
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
About this study
Impaired executive function, such as impaired decision making and impulsivity, has been identified as an important contributor to the transition from suicidal ideation to suicide attempt. To address the epidemic of Veteran suicide in the United States, this study tests the feasibility, acceptability, and preliminary effectiveness of a five day transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention is delivered to high suicide risk inpatients. The ultimate goal is to reduce future suicide events (ideation, attempts, deaths) and improve quality of life (e.g. social relationships, health resource utilization).
- Conditions
- Suicide, Impulsivity
- Being tested
- Active Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Suicide, Impulsive Behavior
- Medical subject headings
- Suicide, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current Stimulation (tDCS)Device
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Sham Transcranial Direct Current Stimulation (tDCS)Device
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | 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). Receives: Device: Active Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS | Sham comparator | 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. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
Measured: 2 years
Intervention Acceptability
Acceptability of the intervention will be demonstrated by a retention rate of 80% at the 2 month follow-up assessment, and by 70% of participants being able to complete ⅔ of treatment sessions.
Measured: 2 months
Secondary outcomes (3)
Change in Completion Time of the Groton Maze Task
Differences in magnitude of change in performance on the Groton Maze Task between active and sham tDCS groups from baseline to follow-up sessions. Outcome score is time to complete task, with longer time indicating worse performance.
Measured: Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.
Change in NIH Quality of Life Questionnaire
Differences in magnitude of change in scores on the NIH Quality of Life (QoL) battery in the domains of cognitive, social, emotional, and behavioral abilities between active and sham tDCS groups from baseline to follow-up sessions. Responses are on a 0-5 Likert scale. The primary outcome measure is the mean Total score across these domains. Higher scores indicate better QoL.
Measured: Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.
Change in UPPS-P Impulsive Behavior Scale
The UPPS-P assesses impulsive behavior in five domains: Positive Urgency, Negative Urgency, (lack of) Premeditation, (lack of) Perseverance, and Sensation Seeking. The scale uses a 1 (agree strongly) to 4 (disagree strongly) response format. The primary outcome measure is the Total score across these domains, calculated as the average of all items in the questionnaire. Higher scores indicate more impulsive behavior.
Measured: Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start2 Nov 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a double-blind, randomized, placebo (sham) controlled feasibility study. Thirty-eight Veteran inpatients in the Minneapolis VA Psychiatric unit will be recruited. Each participant will be randomly assigned to receive either active or sham tDCS, both paired with executive function cognitive training tasks. Training/tDCS sessions will occur twice a day for five days, for a total of 10 sessions. tDCS (2mA current), with anode over left prefrontal cortex and cathode over right prefrontal cortex, will be applied concurrently with cognitive training. Training/tDCS sessions last approx. 45 min, with tDCS applied during the first 20 min of training.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Casey S Gilmore, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231213
- Sponsor's protocol ID
- D4104-P
- Acronym
- ENACTS
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2022
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No