Development of Adaptive Deep Brain Stimulation for OCD
brief summary
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. This current research protocol will focus on the completion of Phase Ib which will implant the RC+S system in 2 subjects.
detailed description
ENROLLMENT: A subject is considered enrolled upon signing informed consent, deemed eligible to be screened by the investigator. The informed consent process may include discussions with the patient¿s family and referring clinician. Medical records that can be obtained will be carefully reviewed to determine adequacy of past treatments including Cognitive Behavioral Therapy (CBT).
A subject identification number will be assigned to each subject that signs consent. This number will be used to identify the subject and must be used on all study documentation related to that subject throughout the study.
SCREENING: Potential subjects meeting inclusion/exclusion criteria and willing to participate in the study as demonstrated by signing the informed consent will be enrolled in the study and undergo 2 screening visits (Visit 1 and Visit 2) spaced over an approximate 1 month period. Diagnostic and screening ratings are completed, followed by complete medical, neurological and neurosurgical evaluations. Final selection of candidates will be made by consensus of the multi-disciplinary investigator team (Project Advisory Committee).
Neuroimaging Methods:
DBS implanted subjects will undergo 2- 3T MRI Scans prior to surgery (1 research MRI at CAMRI and 1 clinical MRI at BSLMC). DBS implanted subjects will under 3 MEGs total.
Control subjects will undergo 1- 3T MRI scan (research MRI scan at CAMRI). Control subjects will also undergo 3 MEG scans.
The Center for Advanced MR Imaging (CAMRI) at the Main Campus location of Baylor College of will perform the research 3T MRI scans, which will only be collected on all subjects (DBS and control) using the Prisma scanner on this project for consistency.
TREATMENT: Subjects eligible for DBS implantation will also have an additional clinical, pre-surgical 3T MRI scan performed at baseline. This scan will be performed on a Philips scanner at Baylor St. Luke's Medical Center (BSLMC). This scan is necessary in order to potentially screen out individuals presenting with brain abnormalities which would not be compatible with the surgery (e.g., congenital defects, lack of normal anatomic correlates) and to assist with surgical planning.
All Subjects (DBS and control) will also undergo MEG scans. This is also needed as a baseline assessment as MEG scans will also be performed post implantation at 2 weeks and 6 months. These scans will be performed on a MEG scanner at the Texas Children¿s Hospital in the Houston Medical Center.
official title
Development of Adaptive Deep Brain Stimulation (aDBS) for the Treatment of Intractable OCD: Phase Ib Using Summit RC+S