Status:
TERMINATED
Non-invasive Brain Modulation for Weight Maintenance
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Nutrition and Obesity Research Center at Harvard (NORC-H)
Conditions:
Obesity
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
Brief Summary
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 rece...
Eligibility Criteria
Inclusion
- Men and women age 20-55 years old
- BMI 30-50 kg/m2
- Willing to undergo 10 week supervised VLCD
Exclusion
- 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):
- Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
- Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).
- Prior neurosurgical procedure or radiation treatment to the brain.
- Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, ventriculoperitoneal shunt or any metallic implant on the head.
- (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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01793766
Start Date
May 1 2013
End Date
June 1 2015
Last Update
October 31 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114