Deep Brain Stimulation Therapy in Movement Disorders

Summary

Participation Requirements

Description

Objective: The purposes of this protocol are: To train NINDS Medical Neurology Branch fellows and other trainees in all aspects of deep brain stimulation (DBS) treatment of medically refractory Parkinson s disease (PD), dystonia, essential tremor (ET) and other indications, including patient selecti...

Objective: The purposes of this protocol are: To train NINDS Medical Neurology Branch fellows and other trainees in all aspects of deep brain stimulation (DBS) treatment of medically refractory Parkinson s disease (PD), dystonia, essential tremor (ET) and other indications, including patient selection, physiology, and programming and management after DBS placement; To maintain a cohort of patients treated with DBS who can participate in other NIH protocols addressing the efficacy of functional surgery and the relevant physiology. To use physiology and efficacy data related to DBS therapy and motor and cognitive function in these patient populations. All the data collected will be an outcome of standard of care and all analyses will be retrospective. All treatment under this protocol will be based on the current standard of care for DBS therapy. Subjects may be enrolled in the study for the teaching value or to support participation in other DBS protocols, or for both reasons. Study Population: Patients 18 years and older with medically refractory PD, dystonia, ET may participate in this study. Other indications will be added with subsequent amendments if FDA approval of deep brain stimulation is extended to other conditions. 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 as a therapeutic option. Patients will be evaluated for their eligibility for the procedure and the risk/benefit balance for surgical therapy will be assesse. After completing the evaluation, a decision will be made on recommending the procedure. At that point the patients will be referred for the surgical intervention to the NIH Surgical Neurology Branch or to collaborating surgeons in the community. If the surgery is performed at the NIH, the Neurology DBS team can be involved in surgical planning, target selection, intraoperative physiology recording and testing, as specified under SNB protocols. After the surgery, the patients will be followed in the NIH DBS clinic and the DBS programming will be initiated and performed as outlined below. The patients will be followed up for at least two years, and then they will have the option to transfer their care back to the neurologists in the community or continue care with the NIH Neurology team if care in the community is not available. In addition, patients can be enrolled in the protocol at various points in relation to DBS surgery. Outcome Measures: The protocol is a teaching protocol and no research questions are addressed prospectively. The main goals of this protocol are (1) to provide training in DBS management procedures to trainees in the Medical Neurology Branch and other sections. and (2) to provide care for patients treated with DBS, whose surgery was performed at NIH or another facility, who could participate in other research protocols at the NIH, (3) To use clinically-generated data on outcome measures, including the change in motor symptoms, as measured by the UPDRS III scale, changes in quality of life for PD patients measured by UPDRS part II and other scales, the Burke-Fahn-Marsden (BFM) dystonia rating scale and the Tremor Rating Scale before and 1 year after treatment, levels of effective drug therapy before and after surgery; change in behavior and performance of activities of daily living; complications of therapy as measured by the UPDRS I, II, and IV scales before and after surgery and the SF-12 score; radiographic correlation of DBS electrode position and clinical changes; neurophysiological mechanisms of DBS and relevant basal ganglia physiology. All data collected will be done as standard of care and all analysis will be retrospective.

Tracking Information