“Development of Adaptive Deep Brain Stimulation for OCD (Phase 1a/1b)”
This research study is for participants that have been diagnosed with intractable Obsessive -compulsive disorder (OCD). OCD is a persistent and oftentimes disabling disorder marked by unwanted and distressing thoughts (obsessions) and irresistible repetitive behaviors. OCD affects 2-3% of the US population, and is responsible for substantial functional impairment and increased risk of early death. The only established first-line treatments for OCD are cognitive-behavioral therapy (CBT) with exposure/response prevention and certain medications. About 30-40% of patients fail to respond and few experience complete symptom resolution. Up to 25% of patients have difficulty tolerating CBT and the risk of relapse after therapies remains large. For the most severe cases, neurosurgery (surgery in the brain), has long been the option of last resort. In this study the investigators want develop an adaptive Deep Brain Stimulation (aDBS) system to use in subjects with intractable (hard to control) OCD. Deep brain stimulation remains investigational for OCD patients and is not considered standard therapy. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed deep brain stimulation may restore balance to dysfunctional brain circuitry implicated in OCD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for OCD treatment. Phase Ia is to gather data to eventually develop a prototype adaptive DBS system for intractable OCD that uses signals from the brain to automatically adjust the DBS stimulation factors. The overall goal is to improve symptom management and reduce stimulation-induced behavioral side effects. Phase Ib will implant the RC+S system in 2 subjects.
Device - Activa PC+S DBS implant for OCD
DBS system consists of the Activa PC+S Neurostimulation System: Model 37604 Activa PC+S Neurostimulator Model 37087 DBS Extension Model 37441 Patient Programmer Model 8181 Sensing Programmer Model 8180 Sensing Programmer Software Nexus D2/D3 System Nexus D2/D3 Application Programming Interface (API) Dow Corning Medical Adhesive, Medtronic Part #080118 Model 3387/3389 DBS Leads Model 37022 External Neurostimulator Model 8840 N'Vision Clinician Programmer Model 8870 Application Card Model 37642 Pa ...read more on ClinicalTrials.org
One Month Blinded Discontinuation Period
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 ...read more on ClinicalTrials.org
Device - Summit RC+S System
Summit RC+S System consists of: (i) One Model B35300R Olympus RC+S neurostimulator; (ii) One Model 4NR009 Patient Therapy Manager; (iii) One Model 4NR011 Clinician Telemetry Module; (iv) Two Model 3387 DBS leads; (v) Two Model 37087-60 DBS extensions; and (vi) One Model 97755 Recharger.
Development of Adaptive Deep Brain Stimulation (aDBS) for the Treatment of Intractable OCD: Phase Ia Using Activa PC+S/ Phase Ib Using Summit RC+S