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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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 groups in NCT05231213
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.

2 Nov 202231 Mar 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Suicide trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
ClinicalTrials.gov ID: NCT05231213
Acronym / sponsor ID: ENACTS / D4104-P
Conditions: Suicide, Impulsivity
Keywords: Suicide, Impulsive Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 2 Nov 2022 (actual)
Primary completion: 31 Mar 2025 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 9 Feb 2022 (actual)
Results: Posted 7 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Active tDCS	Experimental	Device: Active Transcranial Direct Current Stimulation (tDCS)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).
Sham tDCS	Sham comparator	Device: Sham Transcranial Direct Current Stimulation (tDCS)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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active Transcranial Direct Current Stimulation (tDCS)Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.	Device	Active tDCS
Sham Transcranial Direct Current Stimulation (tDCS)Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).	Device	Sham tDCS

Primary outcome

Recruitment Feasibility
Time frame: 2 years
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
Intervention Acceptability
Time frame: 2 months
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.

3 secondary outcomes

Change in Completion Time of the Groton Maze Task
Time frame: 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
Time frame: 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
Time frame: Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.

Results and safety

Results posted to the registry on 7 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active tDCS	7	2
Sham tDCS	7	2

Primary outcome: Recruitment Feasibility

Time frame: 2 years. Count of participants. Unit: Participants

Measure	Active tDCS n = 7	Sham tDCS n = 7
Value	7	7

Population analysed: The study enrolled 14 participants total, falling short of the target of 30 (15 per year for 2 years) due to logistical challenges associated with the inpatient setting.

Primary outcome: Intervention Acceptability

Time frame: 2 months. Mean (Standard Deviation). Unit: Sessions completed

Measure	Active tDCS n = 7	Sham tDCS n = 7
Value	7.7 (4.7)	6.0 (5.4)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active tDCS	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Sham tDCS	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): Recruitment was typically delayed 1-2 days post-admission due to acute substance withdrawal or staffing constraints. So, many subjects were discharged before completing sessions on the unit. Enrollment was challenging but yielded key logistical insights for running studies with volatile inpatient populations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Casey S Gilmore, PhD principal investigator

Minneapolis VA Health Care System, Minneapolis, MN

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Feasibility (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05231213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.