6
Participants
Start Date
April 30, 2014
Primary Completion Date
April 30, 2016
Study Completion Date
April 30, 2016
Deep Brain Stimulation
"If subjects qualify with respect to protocol requirements, the Medtronic Activa system will be implanted with the leads placed bilaterally in the VMH.~Adjustment of DBS parameters at the three months visit will be performed to improve efficacy when the goal of 3% body weight loss mark was not achieved during this period of continuous stimulation. Subjects will be seen monthly after discharge throughout the study period. At visits, safety will be assessed through blood/urine tests, blood pressure measurements, verbal interviews with the subjects and family, quarterly formal psychiatric tests as well as QOL scales.~The determination of efficacy will be the within-group percent change in weight at the end of the DBS treatment period compared to baseline."
Hospital do Coracao, São Paulo
Hospital do Coracao
OTHER