Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding
NCT ID: NCT01632280
Last Updated: 2019-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2012-06-30
2018-07-31
Brief Summary
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Detailed Description
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The study will have the following three aims:
Aim #1: To evaluate whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can improve inhibitory control capacity. For this aim the investigators will evaluate participants' performance in a computerized test of inhibitory control. Results from this aim will provide evidence for target engagement, and thus confirm that the brain circuit of interest was affected as a result of the intervention.
Aim #2: To examine whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can lead to improvements in a self-reported measure of eating control (disinhibition subscale of the three-factor eating questionnaire). Results form this aim will provide evidence for an effect of the intervention on an intermediate, behavioral variable.
Aim #3: To preliminary evaluate whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can improve postoperative weight loss outcomes. This aim will provide preliminary evidence for the clinical efficacy of the intervention over a time window period of 12 months. Weight loss at 12 months will be the primary outcome of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active tDCS
In this arm, participants will receive active tDCS (2mA, 20 min per session). The anode electrode will be placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session they will also perform a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
Transcranial Direct Current Stimulation (tDCS)
tDCS is a well-established, safe and noninvasive neuromodulation technique that is based on the application of a weak direct current to the scalp that flows between two electrodes-anode and cathode. Although there is substantial shunting of current in the scalp, sufficient current penetrates the brain to modify the transmembrane neuronal potential, and thus influence the level of excitability and modulate the firing rate of individual neurons.
In this study, participants will receive 10 daily sessions of tDCS (sham/real) over a period of two weeks.
Sham tDCS
Participants will receive sham tDCS sessions with the same duration and electrode montage as in the real tDCS arm. In this case, current will be applied for 30 s only according to standard procedures, and participants will perform a control task where they will observe and provide responses for the same food and non-food pictures as in the active group task, but without requirement of inhibitory control for performance.
Transcranial Direct Current Stimulation (tDCS)
tDCS is a well-established, safe and noninvasive neuromodulation technique that is based on the application of a weak direct current to the scalp that flows between two electrodes-anode and cathode. Although there is substantial shunting of current in the scalp, sufficient current penetrates the brain to modify the transmembrane neuronal potential, and thus influence the level of excitability and modulate the firing rate of individual neurons.
In this study, participants will receive 10 daily sessions of tDCS (sham/real) over a period of two weeks.
Interventions
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Transcranial Direct Current Stimulation (tDCS)
tDCS is a well-established, safe and noninvasive neuromodulation technique that is based on the application of a weak direct current to the scalp that flows between two electrodes-anode and cathode. Although there is substantial shunting of current in the scalp, sufficient current penetrates the brain to modify the transmembrane neuronal potential, and thus influence the level of excitability and modulate the firing rate of individual neurons.
In this study, participants will receive 10 daily sessions of tDCS (sham/real) over a period of two weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI: 35-60 kg/m2
* Planning to undergo or having undergone laparoscopic adjustable gastric banding (LAGB) within the previous week
Exclusion Criteria
* Pregnancy or planning pregnancy during study period
* Personal or family history of epilepsy or other unexplained loss of consciousness
* Current or past medical history of skin disease or damaged skin on the scalp at site of stimulation
* Active psychiatric or neurological condition
* Prior neurological procedure
* Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculoperitoneal shunt
* Intake of common medications that affect the central nervous system will be allowed if determined okay by MD
20 Years
55 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Miguel Alonso-Alonso, MD
Assistant Professor of Surgery
Principal Investigators
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Miguel Alonso-Alonso, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Bueter M, Thalheimer A, Lager C, Schowalter M, Illert B, Fein M. Who benefits from gastric banding? Obes Surg. 2007 Dec;17(12):1608-13. doi: 10.1007/s11695-007-9263-3. Epub 2007 Nov 21.
Chevallier JM, Paita M, Rodde-Dunet MH, Marty M, Nogues F, Slim K, Basdevant A. Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behavior. Ann Surg. 2007 Dec;246(6):1034-9. doi: 10.1097/SLA.0b013e31813e8a56.
Thalheimer A, Bueter M, Wierlemann A, Lager C, Jurowich C, Germer CT, Fein M. Predictability of outcome in laparoscopic gastric banding. Obes Facts. 2009;2 Suppl 1(Suppl 1):27-30. doi: 10.1159/000198246. Epub 2009 Mar 18.
Spitznagel MB, Garcia S, Miller LA, Strain G, Devlin M, Wing R, Cohen R, Paul R, Crosby R, Mitchell JE, Gunstad J. Cognitive function predicts weight loss after bariatric surgery. Surg Obes Relat Dis. 2013 May-Jun;9(3):453-9. doi: 10.1016/j.soard.2011.10.008. Epub 2011 Oct 29.
Bruce JM, Hancock L, Bruce A, Lepping RJ, Martin L, Lundgren JD, Malley S, Holsen LM, Savage CR. Changes in brain activation to food pictures after adjustable gastric banding. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):602-8. doi: 10.1016/j.soard.2011.07.006. Epub 2011 Jul 27.
Chambers CD, Garavan H, Bellgrove MA. Insights into the neural basis of response inhibition from cognitive and clinical neuroscience. Neurosci Biobehav Rev. 2009 May;33(5):631-46. doi: 10.1016/j.neubiorev.2008.08.016. Epub 2008 Sep 11.
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.
Aron AR, Poldrack RA. The cognitive neuroscience of response inhibition: relevance for genetic research in attention-deficit/hyperactivity disorder. Biol Psychiatry. 2005 Jun 1;57(11):1285-92. doi: 10.1016/j.biopsych.2004.10.026. Epub 2004 Dec 23.
Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.
Goldman RL, Borckardt JJ, Frohman HA, O'Neil PM, Madan A, Campbell LK, Budak A, George MS. Prefrontal cortex transcranial direct current stimulation (tDCS) temporarily reduces food cravings and increases the self-reported ability to resist food in adults with frequent food craving. Appetite. 2011 Jun;56(3):741-6. doi: 10.1016/j.appet.2011.02.013. Epub 2011 Feb 23.
Fregni F, Orsati F, Pedrosa W, Fecteau S, Tome FA, Nitsche MA, Mecca T, Macedo EC, Pascual-Leone A, Boggio PS. Transcranial direct current stimulation of the prefrontal cortex modulates the desire for specific foods. Appetite. 2008 Jul;51(1):34-41. doi: 10.1016/j.appet.2007.09.016. Epub 2007 Dec 23.
Nederkoorn C, Houben K, Hofmann W, Roefs A, Jansen A. Control yourself or just eat what you like? Weight gain over a year is predicted by an interactive effect of response inhibition and implicit preference for snack foods. Health Psychol. 2010 Jul;29(4):389-93. doi: 10.1037/a0019921.
Nederkoorn C, Jansen E, Mulkens S, Jansen A. Impulsivity predicts treatment outcome in obese children. Behav Res Ther. 2007 May;45(5):1071-5. doi: 10.1016/j.brat.2006.05.009. Epub 2006 Jul 7.
Houben K. Overcoming the urge to splurge: influencing eating behavior by manipulating inhibitory control. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):384-8. doi: 10.1016/j.jbtep.2011.02.008. Epub 2011 Feb 24.
Batterink L, Yokum S, Stice E. Body mass correlates inversely with inhibitory control in response to food among adolescent girls: an fMRI study. Neuroimage. 2010 Oct 1;52(4):1696-703. doi: 10.1016/j.neuroimage.2010.05.059. Epub 2010 May 25.
Jacobson L, Javitt DC, Lavidor M. Activation of inhibition: diminishing impulsive behavior by direct current stimulation over the inferior frontal gyrus. J Cogn Neurosci. 2011 Nov;23(11):3380-7. doi: 10.1162/jocn_a_00020. Epub 2011 Mar 31.
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.
Kekic M, McClelland J, Campbell I, Nestler S, Rubia K, David AS, Schmidt U. The effects of prefrontal cortex transcranial direct current stimulation (tDCS) on food craving and temporal discounting in women with frequent food cravings. Appetite. 2014 Jul;78:55-62. doi: 10.1016/j.appet.2014.03.010. Epub 2014 Mar 20.
Jauch-Chara K, Kistenmacher A, Herzog N, Schwarz M, Schweiger U, Oltmanns KM. Repetitive electric brain stimulation reduces food intake in humans. Am J Clin Nutr. 2014 Oct;100(4):1003-9. doi: 10.3945/ajcn.113.075481. Epub 2014 Aug 6.
Lapenta OM, Sierve KD, de Macedo EC, Fregni F, Boggio PS. Transcranial direct current stimulation modulates ERP-indexed inhibitory control and reduces food consumption. Appetite. 2014 Dec;83:42-48. doi: 10.1016/j.appet.2014.08.005. Epub 2014 Aug 13.
Related Links
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Beth Israel Deaconess Medical Center Website
The Obesity Society Website
Weight Loss Surgery website at Beth Israel Deaconess Medical Center, Boston MA Phone 617-667-2845
Other Identifiers
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2012P000121
Identifier Type: -
Identifier Source: org_study_id
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