Deep Brain Stimulation Surgery for Movement Disorders

Summary

Participation Requirements

Description

Objective: The objective of this protocol is to provide DBS surgery and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in people with medically refractory Parkinson s disease (PD), dystonia, and essential tremor (ET). All treatment under this protocol...

Objective: The objective of this protocol is to provide DBS surgery and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in people with medically refractory Parkinson s disease (PD), dystonia, and essential tremor (ET). All treatment under this protocol will be based on the current standard of care for DBS surgery. Study Population: Patients 18 years and older with medically refractory PD, dystonia and/or ET may participate in this study. Study Design The treatment that is rendered in this protocol is standard of care for PD, dystonia, and ET. Patients confirmed to have medically refractory PD, dystonia or ET will be offered DBS. The therapeutic goal of this procedure is to implant chronically stimulating macroelectrodes in the basal ganglia or thalamic nuclei in order to alleviate the symptoms of PD, dystonia or ET. Pre- and post-operative imaging will be used to precisely localize electrode locations within the brain and will be correlated with measures of clinical efficacy and recorded intra-operative neural activity. Intra-operative microelectrode recordings, as well as micro- and macroelectrode electrical stimulation, will be used to confirm positioning of electrode leads. Intra-operative electrode recordings will also be used to investigate the neurophysiological mechanisms of deep brain stimulation and to explore the neural circuits underlying motor and cognitive processing in the basal ganglia. Intraoperative physiology will be used for clinical and research purposes. Patients will be followed for 3 months after the surgical procedure to determine effectiveness of DBS treatment. Outcome Measures: The primary goal of this protocol is to determine the physiology and efficacy of DBS surgery for movement disorders. Efficacy outcome measures include the change in motor symptoms, as measured by the UPDRS III scale, the Burke-Fahn-Marsden (BFM) dystonia rating scale, and the Tremor Rating Scale before and 3 months after treatment. Secondary measures include 1) levels of effective drug therapy before and after surgery; 2) change in behavior and performance of activities of daily living; 3) complications of therapy as measured by the UPDRS I, II, and IV scales before and after surgery and the SF-12 score; 4) radiographic correlation of DBS electrode position and clinical changes; and 5) neurophysiological mechanisms of DBS and motor and cognitive function in the basal ganglia.

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