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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 belowSelect...
My BMI is 25 or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a gastrointestinal condition that could affect drug metabolism.
Select...
I do not have any unstable health conditions like severe liver, kidney issues, recent cancer, or brain disorders.
Select...
I use nicotine or drugs like amphetamines, cocaine, heroin, or marijuana.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year
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 moreTrial 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
2,464 Previous Clinical Trials
4,337,305 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a postmenopausal woman or experiencing symptoms of perimenopause.I am between 18 and 60 years old and not post-menopausal if female.You must be right-handed because the treatment targets a specific part of the brain that has only been studied in right-handed individuals.You must be right-handed because the treatment is specifically designed for the left side of the brain, and the evidence supporting its effectiveness is based on right-handed individuals.My BMI is 25 or higher.I haven't taken any medication that affects my metabolism or appetite in the last three months.I have a gastrointestinal condition that could affect drug metabolism.I have a condition like diabetes or thyroid disorder that affects my appetite or energy.You must be right-handed because the treatment is only tested on the left side of the brain in right-handed people.You have a high body mass index (BMI) of 25 or greater.I use nicotine or drugs like amphetamines, cocaine, heroin, or marijuana.I do not have any unstable health conditions like severe liver, kidney issues, recent cancer, or brain disorders.I am between 18 and 60 years old and not post-menopausal if female.
Research Study Groups:
This trial has the following groups:- Group 1: 3-Sham
- Group 2: 2-Active
- Group 3: 3-Active
- Group 4: 1-Sham
- Group 5: 2-Sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Electrotherapy Patient Testimony for trial: Trial Name: NCT00739362 — Phase 2