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tDCS + Cognitive Training for Obesity

N/A

Recruiting

Led By Shalamar D Sibley, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Obese (BMI>30)

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

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and visit 11, visit 12 (approximately 2 months), and visit 13 (approximately 4 months)

Summary

This trial is investigating whether electrical stimulation can help people with obesity reduce impulsive behavior and lose weight.

Who is the study for?

This trial is for veterans with obesity (BMI>30) who are enrolled in the MOVE! program at Minneapolis VA, aged 18-80, and can understand English. Women of childbearing age must agree to use birth control. Exclusions include substance abuse, severe medical/psychological conditions, history of seizures or head injury, metal implants in the head, pregnancy, certain metabolic disorders or uncontrolled diabetes.

What is being tested?

The study tests if transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, alongside cognitive training can reduce impulsivity and help manage weight in obese individuals. Participants will receive either active tDCS or a sham (placebo) treatment.

What are the potential side effects?

Possible side effects from tDCS may include mild itching or tingling on the scalp during application, fatigue after sessions, headache or nausea. These are typically short-lived and considered minor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is over 30, indicating obesity.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like Cushing's, untreated thyroid issues, or uncontrolled diabetes.

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I have hypothyroidism but am on a stable thyroid medication with normal recent tests.

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I often have severe headaches.

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I have been diagnosed with moderately severe to severe depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and visit 11, visit 12 (approximately 2 months), and visit 13 (approximately 4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and visit 11, visit 12 (approximately 2 months), and visit 13 (approximately 4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and visit 11, visit 12 (approximately 2 months), and visit 13 (approximately 4 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in task impulsivity as measured by the NIH Flanker

Change in weight

Secondary study objectives

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

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

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCS with Cognitive TrainingExperimental Treatment1 Intervention

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.

Group II: Sham tDCS with Cognitive TrainingPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Transcranial Direct Current Stimulation (tDCS)

2020

N/A

~160

0 / 6Eligibility criteria met