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New treatment option for Electric Stimulation Therapy
Official title Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
ClinicalTrials.gov ID: NCT00739362
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only...
- Weight stable (+/- 5 percent) for last 3 months as determined by volunteer report.
You likely can't join if
- 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...
- 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...
- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac...
- Current, unstable medical conditions such as hepatitis, renal insufficiency, cancer requiring treatment in the last 5 years, or central nervous...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.