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Non-invasive Brain Modulation for Weight Maintenance

NCT ID: NCT01793766

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Brain modulation

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

Group Type EXPERIMENTAL

Brain modulation

Intervention Type DEVICE

Brain modulation using Eldith/Neuroconn transcranial Direct Current Stimulation device

Placebo (sham modulation)

10 placebo sessions where no brain modulation takes place

Group Type PLACEBO_COMPARATOR

Sham modulation

Intervention Type DEVICE

Interventions

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Brain modulation

Brain modulation using Eldith/Neuroconn transcranial Direct Current Stimulation device

Intervention Type DEVICE

Sham modulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutrition and Obesity Research Center at Harvard (NORC-H)

UNKNOWN

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Takara Stanley, M.D.

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Takara Stanley, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Miguel Alonso-Alonso, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Winfield S. Butsch, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2013-P-000191

Identifier Type: -

Identifier Source: org_study_id