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

VA Office of Research and Development

Status: Enrolling

Conditions: Obesity

Treatments: Device: Active Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05225233

NURA-009-21S

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

Active tDCS with Cognitive Training

Experimental group

Description:

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.

Treatment:

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS with Cognitive Training

Sham Comparator group

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 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.

Treatment:

Device: Sham Transcranial Direct Current Stimulation (tDCS)