Non-invasive Brain Modulation for Weight Maintenance

Neurobehavioral Contribution to Weight Loss Maintenance: an Interdisciplinary Experimental Study With Noninvasive Brain Modulation

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Device: Brain modulation; Device: Sham modulation

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Nutrition and Obesity Research Center at Harvard (NORC-H)
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimate): February 18, 2013

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2013-P-000191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO