Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder

"Summit RC+S System with ECoG Paddles consists of:~* Olympus RC+S implantable pulse generator (IPG), Model B35300R: 2 per subject x 5 subjects = 10 units~* Extension Leads, Model 37087: 2 per subject X 5 subjects = 10 units~* DBS Leads, Model 3387: 2 per subject X 5 subjects = 10 units~* Patient Therapy Manager (PTM), Model 4NR009: 1 per subject x 5 subjects = 5 units~* Recharge Therapy Manager (RTM), Model 97755: 1 per subject x 5 subjects = 5 units~* Clinician Telemetry Module (CTM), Model 4NR011: 1 per subject x 5 subjects = 5 units~* Research Lab Programmer (RLP), Model 4NR010: 1 unit~* Research Software Development Kit (RDK), Model 4NR013: 2 units~* Subdural Quadripolar Paddle Lead, Model 09130: 2 per subject x 5 subjects = 10 units"

"The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform sham activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline."