N/A
Completed N=12
Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding
Source: ClinicalTrials.gov NCT01632280 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Weight Change — 285.0; 245.3; 273.4; 228.4 pounds (lbs)
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change |
285.0; 245.3; 273.4; 228.4; 280.4; 225.8 | — |
| SECONDARY Eating Disinhibition as Measured by the Three Factor Eating Questionnaire (TFEQ) |
7.0; 3.8; 5.0; 3.6 | — |
| SECONDARY Change From Baseline in Inhibitory Control Over Food as Measured by the Stop Signal Reaction Task |
-72.6; -51.1; -62.3; -46.4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01632280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.