An interventional study of Active Transcranial Direct Current Stimulation (tDCS) and Sham Transcranial Direct Current Stimulation (tDCS) in Suicide and Impulsivity, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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).
158 studies on the registry are indexed under Impulsive Behavior; 31 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 128 interventional studies indexed under Impulsive Behavior.
Browse Impulsive Behavior studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Compared within Impulsive Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: Active 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.
Device: Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
Recruitment Feasibility
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
Time frame: 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.
Time frame: 2 months
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.
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
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.
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
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.
Time frame: Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.
Participants were Veterans recruited based on being admitted to the Minneapolis VA Inpatient Psychiatric unit at heightened risk for suicide. The first participant was enrolled on November 2, 2022, and the last participant was enrolled on November 6, 2024.
| Milestone | Active tDCS | Sham tDCS |
|---|---|---|
| Started | 7 | 7 |
| Completed | 2 | 2 |
| Not completed | 5 | 5 |
| Withdrew: Lost to follow-up | 2 | 4 |
| Withdrew: Withdrawal by subject | 3 | 1 |
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
| Participants | Active tDCS | Sham tDCS |
|---|---|---|
| Recruitment Feasibility | 7 | 7 |
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.
| Sessions completed | Active tDCS | Sham tDCS |
|---|---|---|
| Intervention Acceptability | 7.7 ± 4.7 | 6.0 ± 5.4 |
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.
| Time to complete maze (minutes) | Active tDCS | Sham tDCS |
|---|---|---|
| Baseline | 1.89 ± .48 | 2.34 ± 1.34 |
| Post-Intervention | 1.29 ± .36 | 1.11 ± .05 |
| One month follow-up | 2.62 ± .88 | 2.01 ± .29 |
| Two month follow-up | 1.24 ± 0 | 1.44 ± .36 |
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.
| NIH QoL Total score | Active tDCS | Sham tDCS |
|---|---|---|
| Baseline | 2.58 ± .59 | 2.37 ± .24 |
| Post-Intervention | 2.29 ± .39 | 2.53 ± .17 |
| One month follow-up | 3.35 ± 1.15 | 3.25 ± 0 |
| Two month follow-up | 3.15 ± 0 | 3.25 ± 0 |
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.
| score on a scale | Active tDCS | Sham tDCS |
|---|---|---|
| Baseline | 2.44 ± .46 | 2.16 ± .34 |
| Post-Intervention | 2.35 ± .48 | 2.27 ± .32 |
| One month follow-up | 2.23 ± .13 | 2.17 ± .32 |
| Two month follow-up | 2.30 ± .35 | 2.23 ± .04 |
Collected over From enrollment until end of follow-up, up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active tDCS | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Sham tDCS | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Mean | 46.6 ± 10.5 | 42.4 ± 10.6 | 45.3 ± 10.6 |
| Sex: Female, Male(Participants) | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 6 | 7 | 13 |
| Race (NIH/OMB)(Participants) | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 6 | 6 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 7 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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