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

VA Office of Research and Development

Status: Completed

Conditions: Impulsivity; Suicide

Treatments: Device: Active Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05231213

D4104-P

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups

Active tDCS

Experimental group

Description:

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).

Treatment:

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial Direct Current Stimulation (tDCS)