Clinical trial NCT01793766: Non-invasive Brain Modulation for Weight Maintenance
Official title: Neurobehavioral Contribution to Weight Loss Maintenance: an Interdisciplinary Experimental Study With Noninvasive Brain Modulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Nutrition and Obesity Research Center at Harvard (NORC-H)
First posted: 2013-02-18
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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.


Eligibility criteria: Inclusion Criteria:

1. Men and women age 20-55 years old
2. BMI 30-50 kg/m2
3. Willing to undergo 10 week supervised VLCD

Exclusion Criteria:

1. Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
2. Subjects who have a known history of diabetes, fasting blood sugar \>125 mg/dl or using any anti-diabetic drugs
3. Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
4. Hemoglobin \<10 g/dL, Creatinine \>1.5 mg/dL
5. QT interval \>440 ms on EKG
6. Subjects with unstable psychiatric conditions as assessed by a psychologist
7. Allergy or intolerance to components of the mixed meal challenge
8. Additional contraindications to receive transcranial direct current stimulation (tDCS):

   1. Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
   2. 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.).
   3. Prior neurosurgical procedure or radiation treatment to the brain.
   4. Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
   5. 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.)
9. 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
10. Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient

Primary outcomes:
measure: Change in weight from week 11 to 26
timeFrame: Week 11 to 26
Secondary outcomes:
measure: Change in appetite hormones on mixed meal challenge test
timeFrame: Week 0 to 8, 11 and 26
measure: Change in appetite
timeFrame: Week 0 to 8, 11, 18 and 26
measure: Change in body composition
timeFrame: Week 0 to 8 and 26
measure: Change in metabolic parameters
timeFrame: Week 0 to 8, 11, 18, 26
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Takara Stanley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Miguel Alonso-Alonso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Winfield S. Butsch, MD
role: PRINCIPAL_INVESTIGATOR
References: