Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding

NCT01632280 | Completed Results

• 2 other identifiers: 2012P0001215P30DK046200-20
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

In this project the investigators aim to improve eating control and weight loss outcomes in patients undergoing LAGB with an innovative brain-based intervention. Specifically, the investigators will enhance the activity of the right inferior frontal gyrus, a core region of the brain circuit of inhibitory control, using transcranial direct current stimulation (tDCS).

Conditions

Obesity

Keywords

Obesity; Gastric Banding; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Weight Change

  Participants will be weighed at the indicated time points. Weight loss at 12 months will be the primary outcome of the study.

  Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up

Secondary Outcomes (2)

• Eating Disinhibition as Measured by the Three Factor Eating Questionnaire (TFEQ)

  Baseline and 12 months follow up

• Change From Baseline in Inhibitory Control Over Food as Measured by the Stop Signal Reaction Task

  12 month follow-up vs. Baseline

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

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.

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

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.

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Also known as: Eldith Neuroconn DC Stimulator

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20-55 years old
• BMI: 35-60 kg/m2
• Planning to undergo or having undergone laparoscopic adjustable gastric banding (LAGB) within the previous week

You may not qualify if:

• Unstable medical conditions including poorly controlled diabetes and hypertension
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (20)

• 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.

  PMID: 18030543 BACKGROUND

• 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.

  PMID: 18043107 BACKGROUND

• 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.

  PMID: 20124774 BACKGROUND

• 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.

  PMID: 22133580 BACKGROUND

• 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.

  PMID: 21996599 BACKGROUND

• 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.

  PMID: 18835296 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.

  PMID: 20633386 BACKGROUND

• 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.

  PMID: 15950000 BACKGROUND

• Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.

  PMID: 22085959 BACKGROUND

• 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.

  PMID: 21352881 BACKGROUND

• 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.

  PMID: 18243412 BACKGROUND

• 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.

  PMID: 20658826 BACKGROUND

• 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.

  PMID: 16828053 BACKGROUND

• 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.

  PMID: 21450264 BACKGROUND

• 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.

  PMID: 20510377 BACKGROUND

• 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.

  PMID: 21452949 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.

  PMID: 23986687 BACKGROUND

• 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.

  PMID: 24656950 BACKGROUND

• 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.

  PMID: 25099550 BACKGROUND

• 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.

  PMID: 25128836 BACKGROUND

Related Links

• Beth Israel Deaconess Medical Center Website
• The Obesity Society Website
• American Society for Metabolic and Bariatric Surgery Website
• Weight Loss Surgery website at Beth Israel Deaconess Medical Center, Boston MA Phone 617-667-2845

MeSH Terms

Conditions

Obesity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Recruitment of participants was incomplete due to a decrease/discontinuation of gastric banding procedures throughout the duration of the study and limited funding. Findings may have also been influenced by the effect of band refills.

Results Point of Contact

• Title: Dr. Miguel Alonso-Alonso
• Organization: Beth Israel Deaconess Medical Center

malonso@bidmc.harvard.edu

617-667-0240

Study Officials

• Miguel Alonso-Alonso, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: July 2, 2012
• Study Start: June 1, 2012
• Primary Completion: December 31, 2015
• Study Completion: July 1, 2018
• Last Updated: January 7, 2019
• Results First Posted: February 8, 2018

Record last verified: 2018-12

Locations

US (1)