Non-invasive Brain Modulation for Weight Maintenance

Mass General Brigham

Status and phase: Terminated; Phase 1

Conditions: Obesity

Treatments: Device: Sham modulation; Device: Brain modulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01793766

2013-P-000191

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 2 patient groups, including a placebo group

Brain modulation

Experimental group

Description:

10 sessions of brain modulation with Eldith/Neuroconn transcranial Direct Current Stimulation device

Treatment:

Device: Brain modulation

Placebo (sham modulation)

Placebo Comparator group

Description:

10 placebo sessions where no brain modulation takes place

Treatment:

Device: Sham modulation