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| Name | Class |
|---|---|
| Nutrition and Obesity Research Center at Harvard (NORC-H) | UNKNOWN |
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This is a study of overweight men and women. Everybody will receive a very low calorie diet to eat in place of meals for 10 weeks. During the last two weeks of the diet, half of the patients will receive an intervention to activate parts of their brain that can help them eat less. The other half of the patient will receive a placebo or sham intervention. The intervention will involve a small electric current given every day for 10 days. Everybody will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet to see if the intervention helps people keep the weight off.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain modulation | Experimental | 10 sessions of brain modulation with Eldith/Neuroconn transcranial Direct Current Stimulation device |
|
| Placebo (sham modulation) | Placebo Comparator | 10 placebo sessions where no brain modulation takes place |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain modulation | Device | Brain modulation using Eldith/Neuroconn transcranial Direct Current Stimulation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight from 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. | Week 11 to 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in appetite hormones on mixed meal challenge test | 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. | Week 0 to 8, 11 and 26 |
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Inclusion Criteria:
Exclusion Criteria:
Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
Subjects who have a known history of diabetes, fasting blood sugar >125 mg/dl or using any anti-diabetic drugs
Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
Hemoglobin <10 g/dL, Creatinine >1.5 mg/dL
QT interval >440 ms on EKG
Subjects with unstable psychiatric conditions as assessed by a psychologist
Allergy or intolerance to components of the mixed meal challenge
Additional contraindications to receive transcranial direct current stimulation (tDCS):
(Note: Intake of centrally acting medications will be allowed, as there is no evidence that any medication can increase the risk of adverse effects during tDCS.)
Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit
Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Sham modulation | Device |
|
| Change in appetite | 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. | Week 0 to 8, 11, 18 and 26 |
| Change in body composition | 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. | Week 0 to 8 and 26 |
| Change in metabolic parameters | 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. | Week 0 to 8, 11, 18, 26 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |