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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00739362
Recruitment Status : Recruiting
First Posted : August 21, 2008
Last Update Posted : March 18, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date  ICMJE August 20, 2008
First Posted Date  ICMJE August 21, 2008
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE August 1, 2008
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2019)
Effect of TDCS on weight loss and food intake [ Time Frame: 9 weeks ]
weight food intake
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
Effects of TCDS on weight loss and appetitie.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
Effect of behavioral intervention on weight loss.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Official Title  ICMJE The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss
Brief 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.

Detailed Description

In our studies of brain function examining areas related to hunger and fullness, a part of the brain called the left dorsolateral prefrontal cortex (DLPFC) was found to be less active in obese versus lean individuals following a meal. Furthermore, in women who have lost and maintained weight loss, the activity in this area following a meal is similar to that of lean women, suggesting that the activity in this area may improve with weight loss. Two recent studies have demonstrated a lack of increase in food craving following non-invasive brain stimulation to the left DLPFC when compared to a sham control group that did not receive brain stimulation.

The aim of our protocol is to investigate the effectiveness of one type of noninvasive brain stimulation technique, transcranial direct current stimulation (TDCS) on food intake in significantly overweight (BMI greater than or equal to 30 kg/m(2) individuals. In study 1, we enrolled individuals who previously participated in this study and examined how anodal (active) stimulation or sham (no stimulation) to the left DLPFC compared to their previous stimulation condition in terms of both weight loss and food intake. The aim of Study 2 was to compare active versus sham anodal left DLPFC stimulation in a new group of volunteers.

Study 3 will be a 9 week double-blind parallel outpatient study where volunteers will come to the Clinical Research Unit 3x per week and be randomized to receive either active tDCS or "no stimulation" (sham) to the left DLPFC for stimulation sessions while being asked to follow a diet that is a 25% reduction from their calculated weight maintenance calories. The primary outcome measurement will be total food (kcal) intake during a snack food taste test, and weight change. Volunteers will also undergo 4 sessions of brain imaging (called functional MRI) to help us understand how the stimulation is working. Participants will also be asked to come back to the Unit after 6 months and 1 year for weight measurement. We will also examine appetitive hormones, neurocognitive and behavioral factors, which might also mediate potential changes in food intake and weight following TDCS to the left DLPFC. Positive findings from this study could demonstrate the utility of a novel and safe treatment for severe obesity. Future studies could include longer clinical trials of TDCS with extended follow-up durations.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Electric Stimulation Therapy
  • Obesity
  • Weight Loss
  • Eating
Intervention  ICMJE
  • Device: Transcranial Direct Current Stimulation (TDCS)
    brain stimulation
  • Behavioral: Appetite Control
    change in appetite ratings & snack food intake
  • Behavioral: Weight Loss
    change in weight
Study Arms  ICMJE
  • Experimental: Active
    active tDCS stimulation
    • Device: Transcranial Direct Current Stimulation (TDCS)
    • Behavioral: Appetite Control
    • Behavioral: Weight Loss
  • Sham Comparator: Sham
    • Device: Transcranial Direct Current Stimulation (TDCS)
    • Behavioral: Appetite Control
    • Behavioral: Weight Loss
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2018)
Original Enrollment  ICMJE
 (submitted: August 20, 2008)
Estimated Study Completion Date  ICMJE January 30, 2021
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • BMI greater than or equal to 30 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. Additionally, while the risks of tDCS are minimal, there haven t been studies showing how tDCS might affect the growing brain.
  • Healthy, as determined by medical history, physical examination, and laboratory tests
  • 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


  • Weight less than 350 lbs, as this is the weight limit of the DXA machine
  • Type 2 diabetes (according to the World Health Organization diagnostic criteria)
  • Endocrine disorders (Cushing s disease, pituitary disorders, and hypo- and hyperthyroidism)
  • Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for 1 week before study entry).
  • Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease)
  • Hypertension (blood pressure measurement higher than 140/90 mmHg on 2 or more occasions or use of anti-hypertensive medications)
  • Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g. Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study
  • Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 1.5 times normal)
  • Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or overt proteinuria)
  • Central nervous system disease (cerebrovascular accidents, dementia, neurodegenerative disorders, epilepsy or history of head injury). Personal or first-degree relative with a seizure history.
  • Cancer requiring treatment in the past 5 years, except for non-melanoma skin cancers or cancers that have clearly been cured or, in the opinion of the investigator, carry an excellent prognosis (e.g., Stage 1 cervical cancer)
  • Alcohol (more than 3 drinks per day) and/or drug abuse (such as amphetamines, cocaine, heroin, or marijuana)
  • Smoking more than 5 cigarettes per day
  • Current psychiatric disorder, as diagnosed by the Structured Clinical Interview for DSM-V. Those who report suicidal ideation or clinically significant problems will be immediately referred for appropriate treatment.
  • Presence of metal in the cranial cavity
  • Holes in the skull made by trauma or surgery
  • Pregnancy or lactation. All women (who could bear children) not using a medically approved method of contraception (surgical sterilization, intrauterine device, or a combined method using at least 2 of the following: diaphragm, condom, spermicide) will be excluded.
  • Postmenopausal women or symptoms of perimenopause (e.g. hot flashes, onset of irregular periods following age 40, elevation of FSH greater than 20 IU following age 40 years)
  • Taking weight loss medications or psychotropic medication
  • History of HIV infection or ongoing chronic infection (such as tuberculosis)
  • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.
  • Any conditions contraindicated for MRI (e.g., pacemaker, metal in body, significant claustrophobia).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marci Gluck, Ph.D. (602) 200-5312
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00739362
Other Study ID Numbers  ICMJE 999908191
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marci Gluck, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date November 27, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP