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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 15% 148 → 126 participants
See other at-risk trials from National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Record History

The 50 most recent of 377 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Interventions: Sham/no-stimulation (Other), Transcranial Direct Current Stimulation (TDCS) (Device) to Sham/no-stimulation (Other), Transcranial Direct Current Stimulation (TDCS) (Device) Eligibility criteria expanded, about 17 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 17 words
  2. Minor 5 versions Re-verified since Aug 15, 2026, no change to tracked fieldsv372-v376
  3. Minor Enrollment closed, study ongoing Enrollment reduced: 148 → 126 participants · Site details revisedv371 Show 2 more changesShow less
    • Enrollment reduced: 148 → 126 participants
    • Site details revised
  4. Minor 5 versions Re-verified since Jun 27, 2026, no change to tracked fieldsv366-v370
  5. Notable Primary and study completion pushed from Jul 31, 2026 to Jan 31, 2027v365
Show 37 earlier versionsHide 37 earlier versions
  1. Minor 29 versions Re-verified since Aug 9, 2025, no change to tracked fieldsv336-v364
  2. Notable Primary completion date: Jul 30, 2025 to Jul 31, 2026 Completion date: Jul 31, 2025 to Jul 31, 2026v335 Show 1 more changeShow less
    • Completion date: Jul 31, 2025 to Jul 31, 2026
  3. Minor 7 versions Re-verified since Apr 22, 2025, no change to tracked fieldsv328-v334
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. ...
Trial Details
NCT Number NCT00739362
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Electric Stimulation Therapy, Obesity, Weight Loss, Eating
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov