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

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ClinicalTrials.gov Identifier: NCT00739362
Recruitment Status : Recruiting
First Posted : August 21, 2008
Last Update Posted : April 1, 2021
Sponsor:
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 April 1, 2021
Actual Study Start Date  ICMJE January 19, 2009
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2020)
  • Effect of tDCS on weight loss [ Time Frame: Screening, baseline, weeks 1-9, 6 months, 1 year ]
    Weight (kg)
  • Effect of tDCS on brain fMRI activation in the left DLPFC when shown food vs. nonfood visual cues [ Time Frame: Weeks 1 and 9 ]
    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues
  • Effect of tDCS on food intake [ Time Frame: Baseline, week 9 ]
    Total energy intake during snack food taste test
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
Effects of TCDS on weight loss and appetitie.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2020)
  • Effect of tDCS on macronutrient preferences [ Time Frame: Baseline, week 9 ]
    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, macronutrient preferences determined during snack food taste test
  • Effect of tDCS on responses to behavioral tests and neuropsychological performance tests [ Time Frame: Baseline, week 9 ]
    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires
  • Effect of tDCS on appetitive hormone levels [ Time Frame: Weeks 1 and 9 ]
    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood
  • Correlation between food intake and responses to behavioral tests and neuropsychological performance tests [ Time Frame: Baseline, week 9 ]
    Total energy intake during snack food taste test, performance on questionnaires
  • Correlation between food intake and appetitive hormone levels [ Time Frame: Baseline, weeks 1 and 9 ]
    Total energy intake during snack food taste test, appetitive hormone levels measured in blood
  • Correlation between weight change and responses to behavioral tests and neuropsychological performance tests [ Time Frame: Screening, baseline, weeks 1-9, 6 months, 1 year ]
    Weight (kg), performance on questionnaires
  • Correlation between weight change and appetitive hormone levels [ Time Frame: Screening, baseline, weeks 1-9, 6 months, 1 year ]
    Weight (kg), appetitive hormone levels measured in blood
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)
    Active tDCS (anodal left DLPFC)
  • Other: Sham/no-stimulation
    Sham tDCS
Study Arms  ICMJE
  • Experimental: Active
    active tDCS stimulation
    Intervention: Device: Transcranial Direct Current Stimulation (TDCS)
  • Sham Comparator: Sham
    Sham/no-stimulation
    Intervention: Other: Sham/no-stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2018)
148
Original Enrollment  ICMJE
 (submitted: August 20, 2008)
82
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
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 gmarci@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00739362
Other Study ID Numbers  ICMJE 999908191
08-DK-N191
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: Yes
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 February 22, 2021

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