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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05231213
Recruitment Status : Recruiting
First Posted : February 9, 2022
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Suicide Impulsivity Device: Active Transcranial Direct Current Stimulation (tDCS) Device: Sham Transcranial Direct Current Stimulation (tDCS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 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 Comparator: 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.
 Device: 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).


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment Feasibility [ Time Frame: 2 years ]
    Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.

  2. Intervention Acceptability [ Time Frame: 2 months ]
    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).


Secondary Outcome Measures :
  1. Groton Maze Task [ Time Frame: Change between baseline and 1 week follow-up; 1 and 2 months following intervention ]
    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.

  2. NIH Quality of Life questionnaire [ Time Frame: Change between baseline and 1 week follow-up; 1 and 2 months following intervention ]
    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.

  3. UPPS-P Impulsive Behavior scale [ Time Frame: Change between baseline and 1 week follow-up; 1 and 2 months following intervention ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05231213


Contacts
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Contact: Casey S Gilmore, PhD (612) 725-2000 ext 312051 Casey.Gilmore2@va.gov
Contact: Kelvin O Lim, MD (612) 467-3323 kelvin.lim@va.gov

Locations
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United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Casey S Gilmore, PhD    612-725-2000 ext 312051    Casey.Gilmore2@va.gov   
Principal Investigator: Casey S Gilmore, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Casey S Gilmore, PhD Minneapolis VA Health Care System, Minneapolis, MN
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT05231213    
Other Study ID Numbers: D4104-P
First Posted: February 9, 2022    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Suicide
Impulsive Behavior
Additional relevant MeSH terms:
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Suicide
Impulsive Behavior
Self-Injurious Behavior
Behavioral Symptoms