RecruitingPhase 2NCT00739362

Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss


Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

148 participants

Start Date

Jan 19, 2009

Study Type

INTERVENTIONAL

Conditions

Summary

This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time. Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg/m(2) or more and weigh less than 350 pounds. Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly. After the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS. ...


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether brain stimulation (transcranial magnetic stimulation, or TMS) combined with a behavioral weight loss program is more effective at reducing food intake and promoting weight loss than behavioral therapy alone. TMS is a non-invasive way to stimulate a specific region of the brain using magnetic pulses, and this study targets the area linked to impulse control and appetite regulation. You may be eligible if: - You are between 18 and 60 years old - You are right-handed - Your BMI is 25 kg/m2 or higher (overweight or obese) - Your weight has been stable (within 5%) for the last 3 months You may NOT be eligible if: - You weigh more than 300 pounds (may be considered on a case-by-case basis) - You take medications that affect metabolism or appetite - You are pregnant, have been pregnant in the last 6 months, or are breastfeeding - You have diabetes, thyroid disorders, Cushing's disease, or other conditions affecting appetite or weight - You have gastrointestinal disease, active gastric ulcers, or malabsorption conditions - You have significant alcohol or drug use - You are postmenopausal or perimenopausal - You have any contraindication to MRI (pacemaker, metal in the skull, claustrophobia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial Direct Current Stimulation (TDCS)

Active tDCS (anodal left DLPFC)

OTHERSham/no-stimulation

Sham tDCS


Locations(1)

NIDDK, Phoenix

Phoenix, Arizona, United States

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NCT00739362


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