Noninvasive Neuromodulation of the Prefrontal Cortex in Subjects With Obesity

Summary

The overall goal of this proposal is to evaluate the efficacy of transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, to facilitate weight loss and weight loss maintenance in obesity. This is a novel clinical research study that examines the therapeutic potential of an innovative biomedical treatment for weight loss.

Conditions

• Obesity

Interventions

DEVICE

Active transcranial direct current stimulation (tDCS)

Participants will receive 10 daily sessions (phase 2) and 3 times a week (phase 3) of tDCS (2mA, 30 min per session). The tDCS montage will target the left dorsolateral prefrontal cortex (DLPFC) (anode: F3 based on the 10:20 system; cathode over the right supraorbital area). For stimulation the investigators will use 5x5cm sponge pads that will be soaked in 0.9% saline during the sessions.

OTHER

Hypocaloric diet

During phase 3, participants will undergo a supervised hypocaloric diet intervention for 2 weeks based on a low-calorie diet (LCD) providing a hypocaloric diet based in 20% reduction from total energy expenditure (TEE). The diet will be individualized on the basis of physical activity levels, age for each participant. This intervention will be be conducted at an inpatient, well-controlled setting to guarantee adherence to the diet. Here the diet intervention will be administered in combination with tDCS. tDCS will be applied every other day (Monday, Wednesday, Friday) over the course of these two weeks.

OTHER

Sham transcranial direct current stimulation (tDCS)

Subjects in the control group will receive sham stimulation (placebo) (similar procedure and duration as real tDCS, but here electric current flows for 30 s only, to mimic the subjective sensations that occur with active tDCS).

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• USDA Human Nutrition Research Center on Aging

  collaborator FED

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Vivian MM Suen, MD PhD · University of Sao Paulo

• Sai K Das, PhD · Human Nutrition Research Center on Aging, Tufts University

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-12

Primary Completion

2018-09-03

Completion

2019-03-29

FDA Device

Yes

Countries

• United States
• Brazil

Study Locations