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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility | Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study. | 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Casey S Gilmore, PhD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | United States |
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All 14 participants enrolled in the study were randomized to a treatment arm.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active 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). |
| FG001 | Sham 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active 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). |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Feasibility | Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study. | 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. | Posted | Count of Participants | Participants | 2 years |
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From enrollment until end of follow-up, up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active 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). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Gilmore, PhD | Minneapolis VA Health Care System | 612-629-7466 | casey.gilmore2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2023 | Mar 31, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2024 | May 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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| 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). |
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| 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. | 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. | Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | Sessions completed | 2 months |
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| Secondary | 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. | Differences between the analysis population in any row and the overall analysis population is due to attrition over time. | Posted | Mean | Standard Deviation | Time to complete maze (minutes) | Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions. |
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| Secondary | 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. | Differences between the analysis population in any row and the overall analysis population is due to attrition over time. | Posted | Mean | Standard Deviation | NIH QoL Total score | Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions. |
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| Secondary | 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. | Differences between the analysis population in any row and the overall analysis population is due to attrition over time. | Posted | Mean | Standard Deviation | score on a scale | Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions. |
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| EG001 | Sham 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. | 0 | 7 | 0 | 7 | 0 | 7 |
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