NCT02953353

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2017

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2019

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

October 17, 2016

Last Update Submit

January 20, 2021

Conditions

Obesity

Keywords

ObesityFeeding behaviorTranscranial direct current stimulationWeight loss

Outcome Measures

Primary Outcomes (1)

  • Body weight

    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.

    6 months

Secondary Outcomes (3)

  • Appetite visual analogue scale

    6 months

  • Eating behavior questionnaire

    6 months

  • Cognitive performance in a food modified working memory test

    2 weeks

Study Arms (2)

Active group

ACTIVE COMPARATOR

Active transcranial direct current stimulation (tDCS) and hypocaloric diet.

Device: Active transcranial direct current stimulation (tDCS)Other: Hypocaloric diet

Control group

SHAM COMPARATOR

Sham transcranial direct current stimulation (tDCS) and hypocaloric diet.

Other: Hypocaloric dietOther: Sham transcranial direct current stimulation (tDCS)

Interventions

Active transcranial direct current stimulation (tDCS)DEVICE

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.

Active group
Hypocaloric dietOTHER

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.

Active groupControl group
Sham transcranial direct current stimulation (tDCS)OTHER

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).

Control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Human Nutrition Research Center on Aging, Tufts University

Boston, Massachusetts, 02111-1524, United States

Location

Beth Israel Deaconess Medical Center, Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

Clinical Hospital of Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (10)

  • Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

    PMID: 20633386BACKGROUND

  • Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

    PMID: 10990547BACKGROUND

  • CREUTZFELDT OD, FROMM GH, KAPP H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962 Jun;5:436-52. doi: 10.1016/0014-4886(62)90056-0. No abstract available.

    PMID: 13882165BACKGROUND

  • Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.

    PMID: 16427357BACKGROUND

  • Okamoto M, Dan H, Sakamoto K, Takeo K, Shimizu K, Kohno S, Oda I, Isobe S, Suzuki T, Kohyama K, Dan I. Three-dimensional probabilistic anatomical cranio-cerebral correlation via the international 10-20 system oriented for transcranial functional brain mapping. Neuroimage. 2004 Jan;21(1):99-111. doi: 10.1016/j.neuroimage.2003.08.026.

    PMID: 14741647BACKGROUND

  • Truong DQ, Magerowski G, Blackburn GL, Bikson M, Alonso-Alonso M. Computational modeling of transcranial direct current stimulation (tDCS) in obesity: Impact of head fat and dose guidelines. Neuroimage Clin. 2013 May 31;2:759-66. doi: 10.1016/j.nicl.2013.05.011. eCollection 2013.

    PMID: 24159560BACKGROUND

  • Truong DQ, Magerowski G, Pascual-Leone A, Alonso-Alonso M, Bikson M. Finite Element study of skin and fat delineation in an obese subject for transcranial Direct Current Stimulation. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:6587-90. doi: 10.1109/EMBC.2012.6347504.

    PMID: 23367439BACKGROUND

  • Alonso-Alonso M. Translating tDCS into the field of obesity: mechanism-driven approaches. Front Hum Neurosci. 2013 Aug 27;7:512. doi: 10.3389/fnhum.2013.00512. eCollection 2013.

    PMID: 23986687BACKGROUND

  • Gluck ME, Alonso-Alonso M, Piaggi P, Weise CM, Jumpertz-von Schwartzenberg R, Reinhardt M, Wassermann EM, Venti CA, Votruba SB, Krakoff J. Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity. Obesity (Silver Spring). 2015 Nov;23(11):2149-56. doi: 10.1002/oby.21313.

    PMID: 26530931BACKGROUND

  • Val-Laillet D, Aarts E, Weber B, Ferrari M, Quaresima V, Stoeckel LE, Alonso-Alonso M, Audette M, Malbert CH, Stice E. Neuroimaging and neuromodulation approaches to study eating behavior and prevent and treat eating disorders and obesity. Neuroimage Clin. 2015 Mar 24;8:1-31. doi: 10.1016/j.nicl.2015.03.016. eCollection 2015.

    PMID: 26110109BACKGROUND

MeSH Terms

Conditions

ObesityFeeding BehaviorWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorBody Weight Changes

Study Officials

  • Vivian MM Suen, MD PhD

    University of Sao 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine Department at Ribeirão Preto

Study Record Dates

First Submitted

October 17, 2016

First Posted

November 2, 2016

Study Start

June 12, 2017

Primary Completion

September 3, 2018

Study Completion

March 29, 2019

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)BR(1)