Recruiting

tDCS with Cognitive Training

Sponsor:

VA Office of Research and Development

Code:

NCT05225233

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sham Transcranial Direct Current Stimulation (tDCS)

Active Transcranial Direct Current Stimulation (tDCS)

Study Details

Brief summary:

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.

Conditions

Obesity

Study ID

NCT05225233

Start date

Nov 23, 2022

Status verified date

Sep, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veteran enrolled in a MOVE! Weight Management Program (group or individual) at the Minneapolis VA Health Care System
  • Obese (BMI>30 or BMI>27 plus at least one weight-related comorbidity)
  • Able to understand English, self-consent and follow study-related procedures
  • Willing to use a reliable form of birth control if they are of females of child-bearing potential

Exclusion Criteria:

  • History of any of the following: seizures, severe or moderate head injury, head surgery, significant neurological disorder (significance based on Principal Investigator's judgment)
  • Frequent severe headaches
  • History of scalp conditions such as eczema or seborrheic dermatitis
  • Metal in head (other than in mouth) including shrapnel/surgical clips/welding fragments
  • Implanted medical devices (including pumps and cardiac pacemakers)
  • Pregnancy
  • Acute substance dependence or withdrawal that would affect ability to complete cognitive training
  • Moderately severe to severe depression (as identified on PHQ-9 scale during baseline screening)
  • Other psychological or medical disorders requiring inpatient treatment (as identified during chart review)
  • Presence of a known metabolic or hormonal disorder (such as Cushing's, untreated thyroid dysfunction, or uncontrolled diabetes mellitus defined as a hemoglobin A1c > 8.0), or significant edema/volume overload - all of which would affect weight
  • Uncontrolled hypothyroidism that would affect weight

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Sham Transcranial Direct Current Stimulation (tDCS)

Cognitive training concurrent with sham tDCS (30 seconds ramp up/ramp down at the beginning of the session)

Active Transcranial Direct Current Stimulation (tDCS)

Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

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) ]
  • Change in weight [ Time Frame: Change between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months) ]

Central Contacts and Locations

Central contacts

Shalamar D Sibley, MD

(612) 725-2000Shalamar.Sibley@va.gov

Lisa E Keacher, BS

(612) 467-5203lisa.keacher@va.gov

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Shalamar D Sibley, MD

(612) 725-2000Shalamar.Sibley@va.gov

Principal Investigator:

Shalamar D Sibley, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • transcranial direct current stimulation
  • neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-09-08.