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

Who is this study for? Patients between 18 and 60 years of age who are obese and non-diabetic
What treatments are being studied? Transcranial Direct Current Stimulation
Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• BMI \>= 25 kg/m\^2

• Age 18-60 years. Women who are post-menopausal will be excluded from the study due to changes in their metabolism that could affect weight loss. We will set the cutoff at age 60 so that the age difference between the men and women is not too great for analysis purposes. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules.

• Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only in right-handed individuals).

• Weight stable (+/- 5 percent) for last 3 months as determined by volunteer report.

Locations
United States
Arizona
NIDDK, Phoenix
RECRUITING
Phoenix
Contact Information
Primary
Kat A Ware
wareka@mail.nih.gov
(602) 200-5300
Time Frame
Start Date: 2009-01-19
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 148
Treatments
Sham_comparator: 1-Sham
Active tDCS stimulation
Active_comparator: 2-Active
Active tDCS stimulation
Sham_comparator: 2-Sham
Sham/no-stimulation
Active_comparator: 3-Active
Active tDCS stimulation
Sham_comparator: 3-Sham
Sham/no-stimulation
Authors
Marci Gluck
Related Therapeutic Areas
Sponsors
Leads: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov