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NCT Number: NCT05225233

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location status: Recruiting

Location contact

Shalamar D Sibley, MD

CONTACT

[email protected]

612-725-2000 ext. 4424

Shalamar D Sibley, MD

PRINCIPAL_INVESTIGATOR

About this study

Two-hundred forty individuals will be screened with the goal of consenting and enrolling up to 124 patients and 88 patients completing the study. Participants completing the study will concurrently complete a structured weight loss program. The investigators' study protocol will consist of 13 study visits including four testing days, one before (V1), one on the day of the tenth session of tDCS (V11), another test visit (V12) 6 weeks later, and a final test visit approximately 4 months after beginning stimulation (V13).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Adults, ages 18 years or older (up to age 80)
  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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)

    Differences in the magnitude of change in NIH Flanker Reaction Time (RT) (ms) between active and sham groups from baseline to follow up sessions.

  2. Change in weight

    Time frame: Change between baseline and Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

    Differences in the magnitude of change in weights (kg) between active and sham tDCS (active from baseline to follow up sessions.

Secondary outcomes

  1. Change in reported impulsivity as measured by the Barratt Impulsiveness Scale (BIS)

    Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

    Differences in the magnitude of change in BIS scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions.

  2. Change in reported impulsivity as measured by the UPPS-P Impulsive Behavior Scale (UPPS-P)

    Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

    Differences in the magnitude of change in UPPS-P scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions.

  3. Change in reported binge eating as measured by the Binge Eating Scale (BES)

    Time frame: Change between baseline and Visit 11, Visit 12 (approximately 2 months), and Visit 13 (approximately 4 months)

    Differences in the magnitude of change in BES scores (Likert scale points) will be compared between active and sham tDCS groups from baseline to follow up sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa E Keacher, BS

CONTACT

[email protected]

(612) 467-5203

Shalamar D Sibley, MD

CONTACT

[email protected]

(612) 725-2000 ext. 4424

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Transcranial Direct Current Stimulation (tDCS) With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity: A Clinical Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2022
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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