NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

08-DK-N191

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 60 Years

Referral Letter Required

No

Population Exclusion(s)

Children;
Non-English Speaking

Keywords

Behavioral Weight Loss Treatment;
Obesity;
Appetite Control;
Weight Loss;
Transcranial Direct Current Stimulation (TDCS)

Recruitment Keyword(s)

None

Condition(s)

Electric Stimulation Therapy;
Obesity;
Weight loss;
Eating

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: Transcranial Direct Current Stimulation (TDCS)
Other: Sham/no-stimulation

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

- BMI greater than or equal to 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 (plus or minus 5 percent) for last 3 months as determined by volunteer report.

EXCLUSION CRITERIA:

- Weight > 300 lbs (136 kg), as this is the weight limit of the fMRI machine

- Use of medication affecting metabolism and appetite in the last three months

- Current pregnancy, pregnancy within the past 6 months or currently lactating

- History or clinical manifestations of acute or chronic disorders or conditions that may affect appetite or energy expenditure (such as, but not limited to type 1 or type 2 diabetes, Cushing s disease, thyroid disorders, coccidiomycoses)

- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism

-Current, unstable medical conditions such as hepatitis, renal insufficiency, cancer requiring treatment in the last 5 years, or central nervous system disorders etc. as assessed by history and physical exam

- Evidence of alcohol abuse as defined by greater than or equal to 8 point score on the Alcohol consumption screening AUDIT questionnaire in adults

- Evidence of nicotine use or of drug use such as amphetamines, cocaine, heroin, or marijuana

- Postmenopausal women or symptoms of perimenopause (e.g. hot flashes, onset of irregular periods following age 40, elevation of FSH >20 IU following age 40 years)

- Any conditions contraindicated for MRI (e.g., pacemaker, metal in the cranial cavity, significant claustrophobia, holes in the skull made by trauma or surgery)

- Any condition not specifically mentioned above that, in the opinion of the investigator, may interfere with the study or prove unsafe for participation.


--Back to Top--

Citations:

Gluck ME, Alonso-Alonso M, Piaggi P, Weise CM, Jumpertz-von Schwartzenberg R, Reinhardt M, Wassermann EM, Venti CA, Votruba SB, Krakoff J. Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity. Obesity (Silver Spring). 2015 Nov;23(11):2149-56. doi: 10.1002/oby.21313.

Le DS, Pannacciulli N, Chen K, Salbe AD, Del Parigi A, Hill JO, Wing RR, Reiman EM, Krakoff J. Less activation in the left dorsolateral prefrontal cortex in the reanalysis of the response to a meal in obese than in lean women and its association with successful weight loss. Am J Clin Nutr. 2007 Sep;86(3):573-9. Erratum in: Am J Clin Nutr. 2008 Feb;87(2):463. Del Parigi, Angelo [added].

Heinitz S, Reinhardt M, Piaggi P, Weise CM, Diaz E, Stinson EJ, Venti C, Votruba SB, Wassermann EM, Alonso-Alonso M, Krakoff J, Gluck ME. Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial. Am J Clin Nutr. 2017 Dec;106(6):1347-1357. doi: 10.3945/ajcn.117.158089. Epub 2017 Oct 18.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Marci E. Gluck, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)



Kateri A. Ware
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PIMC BG RM 5-41
4212 N 16TH ST
PHOENIX AZ 85016
(602) 200-5300
wareka@mail.nih.gov

Office of Participant Recruitment (NIDDK Phoenix)

Not Listed
niddkphxcontact@mail.nih.gov

Clinical Trials Number:

NCT00739362

--Back to Top--