tDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
VA Office of Research and Development
Study ID
NCT05225233
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sham Transcranial Direct Current Stimulation (tDCS) — DEVICE
    Cognitive training concurrent with sham tDCS (30 seconds ramp up/ramp down at the beginning of the session)
  • Active Transcranial Direct Current Stimulation (tDCS) — DEVICE
    Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

Study Details

The purpose of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to reduce impulsivity in individuals with obesity, and to evaluate weight change with these individuals. The long-term goal of this research is to develop new treatment approaches for individuals with obesity.

Key Dates

Start date
Nov 23, 2022
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active tDCS with Cognitive Training
    Participants will receive active tDCS stimulation with their cognitive training during a one-hour session each day which includes 20 minutes of stimulation at the beginning of a 46-minute task training session. Ten sessions will be completed over three weeks.
  • Sham Comparator: Sham tDCS with Cognitive Training
    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 seconds, 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.

Primary Outcome Measure

Change in task impulsivity as measured by the NIH Flanker [ Time Frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis VA Health Care System, Minneapolis, MNMinneapolisMinnesota55417-2309
Shalamar D Sibley, MD
612-725-2000
Shalamar D Sibley, MD (PRINCIPAL_INVESTIGATOR)

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