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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Beth Israel Deaconess Medical Center | OTHER |
| USDA Human Nutrition Research Center on Aging | FED |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Active Comparator | Active transcranial direct current stimulation (tDCS) and hypocaloric diet. |
|
| Control group | Sham Comparator | Sham transcranial direct current stimulation (tDCS) and hypocaloric diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite visual analogue scale | 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. | 6 months |
| Eating behavior questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Research Center on Aging, Tufts University | Boston | Massachusetts | 02111-1524 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20633386 | Background | 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. | |
| 10990547 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D005247 | Feeding Behavior |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Hypocaloric diet | Other | 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 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). |
|
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. |
| 6 months |
| Cognitive performance in a food modified working memory test | 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. | 2 weeks |
| Beth Israel Deaconess Medical Center, Harvard Medical School |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Clinical Hospital of Ribeirão Preto | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| 13882165 | Background | 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. |
| 16427357 | Background | 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. |
| 14741647 | Background | 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. |
| 24159560 | Background | 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. |
| 23367439 | Background | 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. |
| 23986687 | Background | 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. |
| 26530931 | Background | 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. |
| 26110109 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D001836 | Body Weight Changes |