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Noninvasive Neuromodulation of the Prefrontal Cortex in Subjects With Obesity

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ClinicalTrials.gov Identifier: NCT02953353
Recruitment Status : Active, not recruiting
First Posted : November 2, 2016
Last Update Posted : June 7, 2018
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Beth Israel Deaconess Medical Center
USDA Human Nutrition Research Center on Aging
Information provided by (Responsible Party):
Vivian Marques Miguel Suen, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Device: Active transcranial direct current stimulation (tDCS) Other: Hypocaloric diet Other: Sham transcranial direct current stimulation (tDCS) Not Applicable

Detailed Description:

The hypothesis is that tDCS will successfully engage prefrontal-related neurobehavioral cognitive control systems, resulting in decreased eating disinhibition and therefore facilitation of weight loss and weight loss maintenance. To test this hypothesis, a 6-month randomized, sham-controlled, double-blind, intervention study was designed. Subjects will undergo an intervention with the following components/phases:

  1. Phase 1 - Target engagement (one session) The purpose of this phase is to examine whether tDCS can reach the brain target, the dorsolateral prefrontal cortex, and influence performance in a neuropsychology tests that depends on the activity of this region. Results from this component of the study will provide evidence for target engagement. Genomic DNA will be extracted from whole blood for sequencing of Catechol-O-methyltransferase (COMT) and brain-derived neurotrophic factor (BDNF) polymorphism genotypes.
  2. Phase 2 - tDCS alone (two weeks) During this phase participants will receive daily tDCS sessions over the course of two weeks (Monday to Friday; total=10 sessions). The purpose of this phase is to examine the effect of modulating the activity of the prefrontal cortex with tDCS on body weight under baseline/weight stable conditions. Also analyse changes in appetite and eating behavior.
  3. Phase 3 - tDCS plus hypocaloric diet (two weeks). During this phase participants will undergo a hypocaloric diet intervention aimed at achieving a 5% body weight reduction at 3 months. 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. The purpose of this component is to examine acute changes in weight associated with tDCS in combination with the diet. Also analyse changes in appetite and eating behavior.
  4. Phase 4 - Follow up (6 months). During this phase (outpatient) changes in body weight over time will be assessed to evaluate weight maintenance. Subjects will be asked to come back to the laboratory at 1, 3 and 6 months. Also analyse changes in appetite and eating behavior.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Noninvasive Neuromodulation of the Prefrontal Cortex in Subjects With Obesity: a Proof-of-concept Study
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Active Comparator: Active group
Active transcranial direct current stimulation (tDCS) and hypocaloric diet.
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.

Sham Comparator: Control group
Sham transcranial direct current stimulation (tDCS) and hypocaloric diet.
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).




Primary Outcome Measures :
  1. Body weight [ Time Frame: 6 months ]
    The primary outcome will be change in body weight after two weeks intervention (tDCS alone) versus baseline (day 1), the change in body weight between the beginning and the end of the inpatient period (tDCS plus hypocaloric diet), and the change in body weight throughout follow-up (6 months), i.e. between the end of the tDCS intervention (end of the inpatient phase) and the end of the study.


Secondary Outcome Measures :
  1. Appetite visual analogue scale [ Time Frame: 6 months ]
    The investigators will analyse changes in appetite during the different phases of the study: phase 1 (target engagement), phase 2 (tDCS-only effect), phase 3 (tDCS plus diet effect), phase 4 (follow-up) using the visual analogue scale.

  2. Eating behavior questionnaire [ Time Frame: 6 months ]
    The investigators will analyse changes in eating behavior during the different phases of the study: phase 1 (target engagement), phase 2 (tDCS-only effect), phase 3 (tDCS plus diet effect), phase 4 (follow-up) using the three-factor eating and food craving questionnaires.

  3. Cognitive performance in a food modified working memory test [ Time Frame: 2 weeks ]
    The investigators will compare accuracy and reaction times before and after the 2 weeks with tDCS only. To evaluate working memory performance an N-back task will be used.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with obesity (BMI 30-35 kg/m2), with stable weight over the previous 3 months.

Exclusion Criteria:

  • pregnancy
  • diabetes
  • acute and chronic kidney disease
  • pancreatitis
  • any active psychiatric or neurological condition at the time of joining the study
  • intake of centrally-acting medications that could interfere with tDCS effects
  • anemia (Hgb <12 g/dl)
  • any other significant medical condition
  • contraindications for tDCS, which includes damaged skin at the site of stimulation, any electrically sensitive or metallic device and history of epilepsy

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): NCT02953353


Locations
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United States, Massachusetts
Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, United States, 02111-1524
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States, 02215
Brazil
Clinical Hospital of Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Beth Israel Deaconess Medical Center
USDA Human Nutrition Research Center on Aging
Investigators
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Principal Investigator: Vivian MM Suen, MD PhD University of São Paulo
Principal Investigator: Sai K Das, PhD Human Nutrition Research Center on Aging, Tufts University
Principal Investigator: Miguel Alonso-Alonso, MD PhD Beth Israel Deaconess Medical Center, Harvard Medical School

Additional Information:
Publications:

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Responsible Party: Vivian Marques Miguel Suen, Professor of Internal Medicine Department at Ribeirão Preto, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02953353     History of Changes
Other Study ID Numbers: Process HCRP: 8463/2016
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Vivian Marques Miguel Suen, University of Sao Paulo:
Obesity
Feeding behavior
Transcranial direct current stimulation
Weight loss

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms