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Brain Stimulation for Obesity

Phase 2
Recruiting
Led By Marci Gluck, Ph.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI greater than or equal to 25 kg/m(2)
Be between 18 and 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year

Summary

This trial will study whether electrical stimulation of 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.

Who is the study for?
This trial is for non-diabetic, right-handed adults aged 18-60 living in Phoenix, AZ with obesity (BMI ≥ 25 kg/m² and weight <350 lbs). Participants should have had a stable weight for the last three months. Exclusions include postmenopausal women, those with conditions affecting appetite or metabolism, recent medication use that affects metabolism/appetite, substance abuse issues, unstable medical conditions, contraindications for MRI scans or any other condition deemed unsafe by the investigator.
What is being tested?
The study tests if brain stimulation of the dorsolateral prefrontal cortex influences food intake and assists in weight loss over four weeks. It involves initial inpatient testing followed by outpatient visits where participants receive either real transcranial direct current stimulation (TDCS) or sham treatment while maintaining a reduced-calorie diet.
What are the potential side effects?
Possible side effects from TDCS may include tingling under electrodes during the procedure. There are no significant side effects expected from sham treatment. The long-term impact on brain function due to repeated sessions of TDCS is not fully known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is 25 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a gastrointestinal condition that could affect drug metabolism.
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I do not have any unstable health conditions like severe liver, kidney issues, recent cancer, or brain disorders.
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I use nicotine or drugs like amphetamines, cocaine, heroin, or marijuana.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brain
food intake
Secondary study objectives
GLP-1
Ghrelin
macronutrient preferences
+7 more

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: 2-ActiveActive Control1 Intervention
Active tDCS stimulation
Group II: 3-ActiveActive Control1 Intervention
Active tDCS stimulation
Group III: 3-ShamPlacebo Group1 Intervention
Sham/no-stimulation
Group IV: 1-ShamPlacebo Group1 Intervention
Active tDCS stimulation
Group V: 2-ShamPlacebo Group1 Intervention
Sham/no-stimulation

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,439 Previous Clinical Trials
4,324,676 Total Patients Enrolled
Marci Gluck, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 Previous Clinical Trials
5,156 Total Patients Enrolled
Marci E Gluck, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 Previous Clinical Trials
5,056 Total Patients Enrolled

Media Library

Transcranial Direct Current Stimulation (TDCS) Clinical Trial Eligibility Overview. Trial Name: NCT00739362 — Phase 2
Electrotherapy Research Study Groups: 3-Sham, 2-Active, 3-Active, 1-Sham, 2-Sham
Electrotherapy Clinical Trial 2023: Transcranial Direct Current Stimulation (TDCS) Highlights & Side Effects. Trial Name: NCT00739362 — Phase 2
Transcranial Direct Current Stimulation (TDCS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00739362 — Phase 2
Electrotherapy Patient Testimony for trial: Trial Name: NCT00739362 — Phase 2
~6 spots leftby Jul 2025
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