Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)

Suicide Clinical Trial

— ENACTS  

Official title:

Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231213
• Other study ID #: D4104-P
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: VA Office of Research and Development
• Contact: Casey S Gilmore, PhD
• Phone: (612) 725-2000
• Email: Casey.Gilmore2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Impulsive Behavior
• Impulsivity
• Suicide

Intervention

Device:
• Active Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
• 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).

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Feasibility	Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.	2 years
Primary	Intervention Acceptability	Acceptability of the intervention will be demonstrated by a retention rate of 80% at the 2 month follow-up assessment, and 70% of subjects tolerating the intervention (able to complete 2/3 of the twice-daily EMA surveys).	2 months
Secondary	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 between baseline and 1 week follow-up; 1 and 2 months following intervention
Secondary	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. Higher scores indicate better QOL.	Change between baseline and 1 week follow-up; 1 and 2 months following intervention
Secondary	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. Higher scores indicate more impulsive behavior.	Change between baseline and 1 week follow-up; 1 and 2 months following intervention