N/A N=12 Randomized Triple-blind Treatment

Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01632280 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Weight Change — 285.0; 245.3; 273.4; 228.4 pounds (lbs)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcranial Direct Current Stimulation (tDCS) (Device)
Age: Adult · 20+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Dec 2015

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	—

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).

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

View full record on ClinicalTrials.gov →

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.