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Non-invasive Brain Modulation for Weight Maintenance

NCT01793766 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-10-31

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Brain modulation

Brain modulation using Eldith/Neuroconn transcranial Direct Current Stimulation device

DEVICE

Sham modulation

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Takara Stanley, MD · Massachusetts General Hospital

  • Miguel Alonso-Alonso, MD · Beth Israel Deaconess Medical Center

  • Winfield S. Butsch, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01793766 on ClinicalTrials.gov