Noninvasive Neuromodulation of the Prefrontal Cortex in Subjects With Obesity

NACompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 12, 2017

Primary Completion Date

September 3, 2018

Study Completion Date

March 29, 2019

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).

Trial Locations (3)

02111-1524

Human Nutrition Research Center on Aging, Tufts University, Boston

02215

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston

14048-900

Clinical Hospital of Ribeirão Preto, Ribeirão Preto

All Listed Sponsors
collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

USDA Human Nutrition Research Center on Aging

FED

lead

University of Sao Paulo

OTHER

NCT02953353 - Noninvasive Neuromodulation of the Prefrontal Cortex in Subjects With Obesity | Biotech Hunter | Biotech Hunter