Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding ("Neuroband")

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborators:
Boston Medical Center
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01632280
First received: June 20, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Obesity
Device: Transcranial Direct Current Stimulation (tDCS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: "Neuroband": The Effect of Perioperative Enhancement of the Brain Circuit of Inhibitory Control in Obese Patients Undergoing Laparoscopic Adjustable Gastric Banding (LAGB)

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Weight Change [ Time Frame: Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up ] [ Designated as safety issue: No ]
    Participants will be weighed at the indicated time points. Weight loss at 12 months will be the primary outcome of the study.


Secondary Outcome Measures:
  • Eating control [ Time Frame: Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up ] [ Designated as safety issue: No ]
    This will be assessed with computerized cognitive tasks that measure inhibitory control over food and a self report questionnaire of eating behavior.


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: 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 Name: Eldith Neuroconn DC Stimulator
Sham Comparator: 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.
Device: 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 Name: Eldith Neuroconn DC Stimulator

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632280

Contacts
Contact: Miguel Alonso-Alonso, MD 617-667-0240 malonso@bidmc.harvard.edu
Contact: Greta Magerowski, BA 617-667-2654 gmagerow@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Miguel Alonso-Alonso, MD    617-667-0240    malonso@bidmc.harvard.edu   
Principal Investigator: Miguel Alonso-Alonso, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Boston Medical Center
Investigators
Principal Investigator: Miguel Alonso-Alonso, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01632280     History of Changes
Other Study ID Numbers: 2012 P- 000121, 5P30DK046200-20
Study First Received: June 20, 2012
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Obesity
Gastric Banding
Transcranial Direct Current Stimulation

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014