Trial Outcomes & Findings for Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS) (NCT NCT05231213)
NCT ID: NCT05231213
Last Updated: 2026-07-07
Results Overview
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
2 years
Results posted on
2026-07-07
Participant Flow
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.
All 14 participants enrolled in the study were randomized to a treatment arm.
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
Baseline characteristics by cohort
| Measure |
Active tDCS
n=7 Participants
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
n=7 Participants
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.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 10.5 • n=20 Participants
|
42.4 years
STANDARD_DEVIATION 10.6 • n=20 Participants
|
45.3 years
STANDARD_DEVIATION 10.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 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.
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
Outcome measures
| Measure |
Active tDCS
n=7 Participants
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
n=7 Participants
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.
|
|---|---|---|
|
Recruitment Feasibility
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 2 monthsAcceptability 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.
Outcome measures
| Measure |
Active tDCS
n=7 Participants
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
n=7 Participants
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.
|
|---|---|---|
|
Intervention Acceptability
|
7.7 Sessions completed
Standard Deviation 4.7
|
6.0 Sessions completed
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.Population: Differences between the analysis population in any row and the overall analysis population is due to attrition over time.
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.
Outcome measures
| Measure |
Active tDCS
n=7 Participants
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
n=7 Participants
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.
|
|---|---|---|
|
Change in Completion Time of the Groton Maze Task
Baseline
|
1.89 Time to complete maze (minutes)
Standard Deviation .48
|
2.34 Time to complete maze (minutes)
Standard Deviation 1.34
|
|
Change in Completion Time of the Groton Maze Task
Post-Intervention
|
1.29 Time to complete maze (minutes)
Standard Deviation .36
|
1.11 Time to complete maze (minutes)
Standard Deviation .05
|
|
Change in Completion Time of the Groton Maze Task
One month follow-up
|
2.62 Time to complete maze (minutes)
Standard Deviation .88
|
2.01 Time to complete maze (minutes)
Standard Deviation .29
|
|
Change in Completion Time of the Groton Maze Task
Two month follow-up
|
1.24 Time to complete maze (minutes)
Standard Deviation 0
|
1.44 Time to complete maze (minutes)
Standard Deviation .36
|
SECONDARY outcome
Timeframe: Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.Population: Differences between the analysis population in any row and the overall analysis population is due to attrition over time.
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.
Outcome measures
| Measure |
Active tDCS
n=7 Participants
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
n=7 Participants
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.
|
|---|---|---|
|
Change in NIH Quality of Life Questionnaire
Baseline
|
2.58 NIH QoL Total score
Standard Deviation .59
|
2.37 NIH QoL Total score
Standard Deviation .24
|
|
Change in NIH Quality of Life Questionnaire
Post-Intervention
|
2.29 NIH QoL Total score
Standard Deviation .39
|
2.53 NIH QoL Total score
Standard Deviation .17
|
|
Change in NIH Quality of Life Questionnaire
One month follow-up
|
3.35 NIH QoL Total score
Standard Deviation 1.15
|
3.25 NIH QoL Total score
Standard Deviation 0
|
|
Change in NIH Quality of Life Questionnaire
Two month follow-up
|
3.15 NIH QoL Total score
Standard Deviation 0
|
3.25 NIH QoL Total score
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.Population: Differences between the analysis population in any row and the overall analysis population is due to attrition over time.
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.
Outcome measures
| Measure |
Active tDCS
n=7 Participants
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
n=7 Participants
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.
|
|---|---|---|
|
Change in UPPS-P Impulsive Behavior Scale
Baseline
|
2.44 score on a scale
Standard Deviation .46
|
2.16 score on a scale
Standard Deviation .34
|
|
Change in UPPS-P Impulsive Behavior Scale
Post-Intervention
|
2.35 score on a scale
Standard Deviation .48
|
2.27 score on a scale
Standard Deviation .32
|
|
Change in UPPS-P Impulsive Behavior Scale
One month follow-up
|
2.23 score on a scale
Standard Deviation .13
|
2.17 score on a scale
Standard Deviation .32
|
|
Change in UPPS-P Impulsive Behavior Scale
Two month follow-up
|
2.30 score on a scale
Standard Deviation .35
|
2.23 score on a scale
Standard Deviation .04
|
Adverse Events
Active tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place