Non-invasive Brain Modulation for Weight Maintenance
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|ClinicalTrials.gov Identifier: NCT01793766|
Recruitment Status : Terminated
First Posted : February 18, 2013
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: Brain modulation Device: Sham modulation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Neurobehavioral Contribution to Weight Loss Maintenance: an Interdisciplinary Experimental Study With Noninvasive Brain Modulation|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Brain modulation
10 sessions of brain modulation with Eldith/Neuroconn transcranial Direct Current Stimulation device
Device: Brain modulation
Brain modulation using Eldith/Neuroconn transcranial Direct Current Stimulation device
Placebo Comparator: Placebo (sham modulation)
10 placebo sessions where no brain modulation takes place
Device: Sham modulation
- Change in weight from week 11 to 26 [ Time Frame: Week 11 to 26 ]Patients will be placed on a very low calorie diet from baseline to week 11. The primary end point is the maintenance of weight loss from week 11 to week 26 after the very low calorie diet is stopped.
- Change in appetite hormones on mixed meal challenge test [ Time Frame: Week 0 to 8, 11 and 26 ]Appetite hormones such as ghrelin change in response to nutrition. Dieting increases ghrelin and decreases other appetite hormones. We will assess if the brain modulation intervention will prevent the dieting induced increase in ghrelin and changes in other appetite hormones.
- Change in appetite [ Time Frame: Week 0 to 8, 11, 18 and 26 ]Degree of hunger (or satiety) can be assessed by use of visual analog scale and monitoring food intake diaries and questionnaires. We will assess if the brain modulation intervention can prevent the diet induced increases in appetite using the visual analog scale, food diary and questionnaires.
- Change in body composition [ Time Frame: Week 0 to 8 and 26 ]Weight loss can affect both fat mass and muscle (lean) mass. We will assess if the weight loss by low-calorie diet and weight maintenane facilitated by brain modulation will preferentially affect fat mass or lean mass by use of dual energy X-ray absorptiometry.
- Change in metabolic parameters [ Time Frame: Week 0 to 8, 11, 18, 26 ]Weight loss and successful weight loss maintenance can improve insulin resistance (risk for diabetes mellitus) and cholesterol profile. We will assess the changes in risk for diabetes and cholesterol from the low-calorie diet and brai modulation mediated weight maintenance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793766
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Takara Stanley, MD||Massachusetts General Hospital|
|Principal Investigator:||Miguel Alonso-Alonso, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Winfield S. Butsch, MD||Massachusetts General Hospital|