RecruitingNot ApplicableNCT05225233

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

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


Sponsor

VA Office of Research and Development

Enrollment

124 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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

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Interventions

DEVICESham Transcranial Direct Current Stimulation (tDCS)

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

DEVICEActive Transcranial Direct Current Stimulation (tDCS)

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


Locations(1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

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NCT05225233


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