Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 20 - 55 |
Updated: | 1/9/2019 |
Start Date: | June 2012 |
End Date: | July 2018 |
"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).
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).
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.
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.
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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Miguel Alonso-Alonso, MD
Phone: 617-667-0240
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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