Deep Brain Stimulation Therapy in Movement Disorders
National Institute of Neurological Disorders and Stroke (NINDS)
Summary
Background: \- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement. DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET). Objective: \- To provide DBS treatment to people with some movement disorders. Eligibility: \- Adults 18 years and older with PD, ET, or certain forms of dystonia. Design: * Participants will be screened with medical history and physical exam. They will have blood and urine tests and: * MRI brain scan. The participant will lie on a table that slides in and out of a metal cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will get earplugs for the loud noises. During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected. * Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and legs. They record heart activity. * Chest X-ray. * Tests of memory, attention, concentration, thinking, and movement. * Eligible participants will have DBS surgery. The surgery and hospital care afterward are NOT part of this protocol. * Study doctors will see participants 3 4 weeks after surgery to turn on the neurostimulator. * Participants will return every month for 3 months, then every 3 months during the first year, and every 6 months during the second year. Each time, participants will be examined and answer questions. DBS placement will be evaluated with MRI. The neurostimulator will be programmed. At two visits, participants will have tests of movements, thinking, and memory.
Description
Objective The purposes of this protocol are: To provide DBS therapy and follow-up management 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 collect physiology, programming, 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 ther…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: To be eligible for entry into the study, candidates must meet all the following criteria: * Be 18 years of age or older. * Able to comply with study procedures and provide informed consent. * Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET: 1. The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic. 2. The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movem…
Interventions
- DeviceDeep Brain Stimulation management
The DBS surgery will be performed according to standard of care in the centers of referral. If performed at the NIH, this will be done under protocol 11-N-0211 or other protocols permitting DBS surgery depending on future availability.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland