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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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.

Description

Two-hundred forty individuals will be screened with the goal of consenting and enrolling 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).

Eligibility

Inclusion Criteria:

  • Veteran enrolled in the MOVE! Weight Management Program at the Minneapolis VA Health Care System
  • Obese (BMI>30)
  • 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
  • Active substance abuse
  • 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
  • History of hypothyroidism is acceptable if subject is on treatment with normal thyroid stimulating hormone (TSH) and FT4 on most recent check within the last 3 months and has been on stable dosage of l-thyroxine for at least 3 months, taking it as prescribed.

Study details
    Obesity

NCT05225233

VA Office of Research and Development

27 January 2024

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