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Non-invasive Brain Modulation for Weight Maintenance

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ClinicalTrials.gov Identifier: NCT01793766
Recruitment Status : Terminated
First Posted : February 18, 2013
Last Update Posted : October 31, 2016
Sponsor:
Collaborator:
Nutrition and Obesity Research Center at Harvard (NORC-H)
Information provided by (Responsible Party):
Takara Stanley, M.D., Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Device: Brain modulation Device: Sham modulation Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Neurobehavioral Contribution to Weight Loss Maintenance: an Interdisciplinary Experimental Study With Noninvasive Brain Modulation
Study Start Date : May 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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



Primary Outcome Measures :
  1. Change in weight from week 11 to 26 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in appetite hormones on mixed meal challenge test [ Time Frame: Week 0 to 8, 11 and 26 ]
    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.

  2. Change in appetite [ Time Frame: Week 0 to 8, 11, 18 and 26 ]
    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.

  3. Change in body composition [ Time Frame: Week 0 to 8 and 26 ]
    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.

  4. Change in metabolic parameters [ Time Frame: Week 0 to 8, 11, 18, 26 ]
    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.



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793766


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Nutrition and Obesity Research Center at Harvard (NORC-H)
Investigators
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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

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Responsible Party: Takara Stanley, M.D., Assistant Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01793766    
Other Study ID Numbers: 2013-P-000191
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No