Actively Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-01
300
Participants Needed
1
Research Sites
869 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Deep Brain Stimulation Therapy in Movement Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older.
- Able to comply with study procedures and provide informed consent.
- Have a clinical diagnosis of idiopathic Parkinson's disease, primary dystonia, or essential tremor confirmed by clinical examination.
- For Parkinson's disease, show at least 30% motor improvement with L-DOPA or have tremor-dominant disease with specific motor scores.
- Have unsatisfactory response to maximum medical management, including persistent disabling symptoms or side effects.
- Interested in evaluation for DBS or already implanted with DBS for continued management.
You will not qualify if you...
- Clinically significant medical diseases increasing surgical risk (e.g., uncontrolled hypertension, unstable heart or respiratory disease, coagulation problems).
- Evidence of secondary or atypical parkinsonism, dystonia, or tremor due to stroke, toxins, neuroleptics, encephalitis, or other neurological signs.
- MRI evidence of secondary brain disease like tumor or stroke.
- Dementia or inability to complete cognitive assessments.
- Unstable psychiatric disorders increasing surgical risk.
- Inability to undergo MRI due to implanted devices, metal fragments, claustrophobia, or inability to lie still.
- Pregnant women.
- Known inability to undergo anesthesia or other contraindications for DBS surgery.
- For those with DBS, contraindications to ongoing stimulation such as intractable side effects despite parameter adjustments.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
I
Irene H Dustin, C.R.N.P.
CONTACT
D
Debra J Ehrlich, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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