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

NCT00739362 | Recruiting Phase 2

• 2 other identifiers: 99990819108-DK-N191
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Electric Stimulation Therapy; Weight Loss; Eating

Keywords

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

Outcome Measures

Primary Outcomes (3)

• weight loss

  Weight (kg)

  Baseline, week 9

• food intake

  Total energy intake during snack food taste test

  Baseline, week 9

• brain fMRI activation in the left DLPFC when shown food vs. nonfood visual cues

  Percent signal change in the left DLPFC when shown food vs. nonfood visual cues

  Weeks 1 and 9

Secondary Outcomes (11)

• weight loss

  Baseline, 6 months

• responses to Iowa Gambling Task

  Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

• responses to Three Factor Eating Questionnaire

  Baseline, week 9

• responses to MacArthur Scale of Subjective Social Status

  Baseline, week 9

• responses to Gormally Binge Eating Questionnaire

  Baseline, week 9

Study Arms (5)

1-Sham

SHAM COMPARATOR

Active tDCS stimulation

Device: Transcranial Direct Current Stimulation (TDCS)

2-Active

ACTIVE COMPARATOR

Active tDCS stimulation

Device: Transcranial Direct Current Stimulation (TDCS)

2-Sham

SHAM COMPARATOR

Sham/no-stimulation

Other: Sham/no-stimulation

3-Active

ACTIVE COMPARATOR

Active tDCS stimulation

Device: Transcranial Direct Current Stimulation (TDCS)

3-Sham

SHAM COMPARATOR

Sham/no-stimulation

Other: Sham/no-stimulation

Interventions

Sham/no-stimulation OTHER

Sham tDCS

2-Sham; 3-Sham

Transcranial Direct Current Stimulation (TDCS) DEVICE

Active tDCS (anodal left DLPFC)

1-Sham; 2-Active; 3-Active

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Weight \> 300 lbs (136 kg), as this is the general size limit of the fMRI machine. Participants \>300 pounds may be included if their body habitus will allow them to fit within the diameter of the MRI machine. This will be determined on a case-by-case basis after consultation with staff at Banner Health Neuroimaging Center.
• 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 \>= 8 point score on the Alcohol consumption screening AUDIT questionnaire in adults
• Evidence of drug use such as amphetamines, cocaine, heroin, or marijuana
• Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstr(SqrRoot)(Delta)m Test for Nicotine Dependence Tool (score greater than 2)
• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 26530931 BACKGROUND

• 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. doi: 10.1093/ajcn/86.3.573.

  PMID: 17823419 BACKGROUND

• 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.

  PMID: 29046305 BACKGROUND

• Stinson EJ, Travis KT, Magerowski G, Alonso-Alonso M, Krakoff J, Gluck ME. Improved food Go/No-Go scores after transcranial direct current stimulation (tDCS) to prefrontal cortex in a randomized trial. Obesity (Silver Spring). 2022 Oct;30(10):2005-2013. doi: 10.1002/oby.23529. Epub 2022 Sep 2.

  PMID: 36052819 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Marci E Gluck, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kat A Ware

CONTACT

(602) 200-5300; wareka@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: January 19, 2009
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06-08

Locations

US (1)