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

Primary Purpose

Suicide, Impulsivity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation (tDCS)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide, Impulsive Behavior

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Minneapolis VA Health Care System, Minneapolis, MNRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm 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).

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.

Outcomes

Primary Outcome Measures

Recruitment Feasibility
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 28, 2022
Last Updated
June 14, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05231213
Brief Title
Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
Acronym
ENACTS
Official Title
Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Impulsivity
Keywords
Suicide, Impulsive Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm 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).
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
Primary Outcome Measure Information:
Title
Recruitment Feasibility
Description
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
Time Frame
2 years
Title
Intervention Acceptability
Description
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).
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Groton Maze Task
Description
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.
Time Frame
Change between baseline and 1 week follow-up; 1 and 2 months following intervention
Title
NIH Quality of Life questionnaire
Description
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.
Time Frame
Change between baseline and 1 week follow-up; 1 and 2 months following intervention
Title
UPPS-P Impulsive Behavior scale
Description
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.
Time Frame
Change between baseline and 1 week follow-up; 1 and 2 months following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casey S Gilmore, PhD
Phone
(612) 725-2000
Ext
312051
Email
Casey.Gilmore2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kelvin O Lim, MD
Phone
(612) 467-3323
Email
kelvin.lim@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casey S Gilmore, PhD
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417-2309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey S Gilmore, PhD
Phone
612-725-2000
Ext
312051
Email
Casey.Gilmore2@va.gov
First Name & Middle Initial & Last Name & Degree
Casey S Gilmore, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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