Brain stimulation effects on food intake and weight loss
The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss
This study is testing if a type of brain stimulation can help people who are obese eat less and lose weight over four weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT00739362 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of transcranial direct current stimulation (tDCS) on the dorsolateral prefrontal cortex to assess its effects on food intake and weight loss in obese individuals. Participants will undergo a series of tests, including meal tests and psychological assessments, over a 4-week period, with some receiving active stimulation and others receiving sham stimulation. The study aims to determine if brain stimulation can help control appetite and promote weight loss, comparing results between those who receive counseling and those who do not.
Who should consider this trial
Good fit: Ideal candidates are obese, non-diabetic individuals aged 18 to 60 with a BMI of 35 kg/m² or more, residing in the Phoenix, AZ metropolitan area.
Not a fit: Patients who are under 18, post-menopausal women, or those with a weight over 300 lbs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method for managing obesity and improving weight loss outcomes.
How similar studies have performed: Previous studies have shown promising results with non-invasive brain stimulation techniques, suggesting potential effectiveness in appetite control.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * 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. EXCLUSION CRITERIA: * 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.
Where this trial is running
Phoenix, Arizona
- NIDDK, Phoenix — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Marci E Gluck, Ph.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Kat A Ware
- Email: wareka@mail.nih.gov
- Phone: (602) 200-5300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.