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Obesity"Neuroband"NCT01632280

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

A study testing Transcranial Direct Current Stimulation (tDCS) in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 55 years
Conditions the study is for
Obesity
What is being tested?
Transcranial Direct Current Stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteUnited States
Study dates
Jun 2012to Jul 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: "Neuroband": The Effect of Perioperative Enhancement of the Brain Circuit of Inhibitory Control in Obese Patients Undergoing Laparoscopic Adjustable Gastric Banding (LAGB)

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).

Read the detailed description

Laparoscopic Adjustable Gastric Banding (LAGB) is a minimally invasive and reversible procedure in bariatric surgery that has a good safety record. Despite these advantages, success rates following LAGB are quite variable across individuals. Recent data suggest that complementing LAGB with interventions targeting factors along the brain-behavior spectrum could enhance weight loss results following this procedure.

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
Obesity
Being tested
Transcranial Direct Current Stimulation (tDCS)
Keywords
Obesity, Gastric Banding, Transcranial Direct Current Stimulation
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Direct Current Stimulation (tDCS)Device

    Also called Eldith Neuroconn DC Stimulator

    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.

Study groups in NCT01632280
Study groupRoleWhat they receive
Active tDCSActive comparatorIn 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.
Receives: Device: Transcranial Direct Current Stimulation (tDCS)
Sham tDCSSham comparatorParticipants 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.
Receives: Device: Transcranial Direct Current Stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

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

    Eating Disinhibition is an eating behavior trait that reflects a tendency towards overeating and eating opportunistically in an obesogenic environment. Examples include eating in response to negative affect, overeating when others are eating, not being able to resist temptations to eat, and overeating in response to the palatability of food (Bryant, King and Blundell. Obes Rev. 2008;9:409-19). Eating disinhibition was measured using the Three Factor Eating Questionnaire (TFEQ), which contains 16 questions for this factor. Responses are scored 0 or 1 and summed, thus eating disinhibition score ranges from 0 to 16. Higher scores denote higher levels of eating disinhibition.

    Measured: Baseline and 12 months follow up

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

    Inhibitory control over food was measured with a Stop Signal Task that was modified with the presence of distractors of two types: images of food and neutral images (control). The Stop Signal Task is a computerized task that evaluates an individual's ability to interrupt a motor response after its initiation (Logan 1994). Subjects were asked to press a response key matching the direction of an arrow, but refrain from pressing when an auditory cue ("stop signal") appeared (25% trials). The main outcome of the task is the Stop-Signal-Reaction-Time (SSRT), in milliseconds, which reflects how long it takes to inhibit a response when a stop signal appears. The SSRT is considered a laboratory measure of inhibitory control capacity. Shorter SSRT reflects more efficient inhibitory control. Here a reduction of SSRT from baseline to 12 months indicates improvement in inhibitory capacity. We provide SSRT changes for food and neutral images, reflecting specific and general effects, respectively.

    Measured: 12 month follow-up vs. Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2012 (estimated)
  2. Study startJun 2012
  3. Primary completion31 Dec 2015
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632280
Sponsor's protocol ID
2012P000121
Other IDs
5P30DK046200-20
Acronym
"Neuroband"
Status last verified
Dec 2018
First submitted
20 Jun 2012
Last updated
7 Jan 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 18030543

  • 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.

    PubMed 18043107

  • 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.

    PubMed 20124774

  • 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.

    PubMed 22133580

  • 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.

    PubMed 21996599

  • 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.

    PubMed 18835296

  • 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.

    PubMed 20633386

  • 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.

    PubMed 15950000

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

    PubMed 22085959

  • 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.

    PubMed 21352881

  • 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.

    PubMed 18243412

  • 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.

    PubMed 20658826

  • 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.

    PubMed 16828053

  • 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.

    PubMed 21450264

  • 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.

    PubMed 20510377

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation (tDCS) in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change (time frame: Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01632280, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.

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