Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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).
    

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.
    

Intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): 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 name(s): Eldith Neuroconn DC Stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Gastric Banding; Transcranial Direct Current Stimulation