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

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Aug 20, 2008

Keywords

ClinConnect Summary

This clinical trial is studying how electrical stimulation of a specific part of the brain can help with weight loss and controlling food intake. The area being targeted, called the dorsolateral prefrontal cortex, plays a key role in how full we feel after eating. The researchers want to see if stimulating this area can lead to less eating and more weight loss over a period of four weeks. They will also compare the weight changes in participants who attend weight loss counseling sessions with those who do not.

To participate, individuals must be non-diabetic, between 18 and 60 years old, and have a body mass index (BMI) of 35 or higher. They should be generally healthy and live in the Phoenix, AZ area. Participants will spend the first nine days of the study in a research unit where they will undergo various tests, including meal tests and scans to measure body fat. Then, they will go home and follow a lower-calorie diet for four weeks, while returning to the unit three times a week for either real or sham (fake) brain stimulation. This trial aims to find new ways to help people manage their weight effectively.

Gender

ALL

Eligibility 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.