Overview

This trial is active, not recruiting.

Condition obesity
Treatment transcranial direct current stimulation (tdcs)
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator Boston Medical Center
Start date June 2012
End date February 2017
Trial size 14 participants
Trial identifier NCT01632280, 2012 P- 000121, 5P30DK046200-20

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(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.
transcranial direct current stimulation (tdcs) 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.
(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.
transcranial direct current stimulation (tdcs) 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.

Primary Outcomes

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

Secondary Outcomes

Measure
Eating control
time frame: Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up

Eligibility Criteria

Male or female participants from 20 years up to 55 years old.

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

Additional Information

Official title "Neuroband": The Effect of Perioperative Enhancement of the Brain Circuit of Inhibitory Control in Obese Patients Undergoing Laparoscopic Adjustable Gastric Banding (LAGB)
Principal investigator Miguel Alonso-Alonso, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.