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

NCT05225233 | Recruiting DMC FDA Device

• 1 other identifier: NURA-009-21S
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

transcranial direct current stimulation; neuromodulation

Outcome Measures

Primary Outcomes (2)

• Change in task impulsivity as measured by the NIH Flanker

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

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

• Change in weight

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

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

Secondary Outcomes (3)

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

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

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

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

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

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

Study Arms (2)

Active tDCS with Cognitive Training

EXPERIMENTAL

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.

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS with Cognitive Training

SHAM COMPARATOR

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.

Device: Sham Transcranial Direct Current Stimulation (tDCS)

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)

Sham tDCS with Cognitive Training

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.

Active tDCS with Cognitive Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shalamar D Sibley, MD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalamar D Sibley, MD

CONTACT

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

Lisa E Keacher, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 4, 2022
• Study Start: November 23, 2022
• Primary Completion: March 14, 2026
• Study Completion: April 30, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)