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Deep Brain Stimulation for Movement Disorders

This study is looking at Deep Brain Stimulation (DBS) therapy for people with movement disorders like Parkinson's Disease. DBS involves placing a small device in your chest, connected to wires in your brain, to help control movement. The main goals are to provide DBS treatment and follow-up care, and to gather information about how DBS affects movement and thinking. This information can then be used in other research studies. You might be able to join if you are 18 or older and have Parkinson's Disease, essential tremor (ET), or certain types of dystonia. This study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 300 participants. It focuses on providing standard Deep Brain Stimulation (DBS) therapy.
What's involved
You will have a medical history and physical exam, blood and urine tests, and an MRI brain scan lasting about 60 minutes. Follow-up management will continue for two years.
Compensation
Not stated in the trial record.
Follow-up
Participants will receive follow-up management for two years after receiving Deep Brain Stimulation (DBS) therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02119611

Deep Brain Stimulation Therapy in Movement Disorders

Recruiting
NAAges 18+InterventionalTreatment
National Institute of Neurological Disorders and Stroke (NINDS)
~300 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Deep Brain Stimulation management

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To provide DBS therapy and follow-up management
Measured over two years
+2 more outcomes measured

Conditions

Parkinson's Disease

Explore related trials

DystoniaEssential TremorParkinson Disease

NCT02119611

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Debra J Ehrlich, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)

Who to contact

Irene H Dustin, C.R.N.P.
[email protected]
(301) 402-4479
Email the study team

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Eligibility criteria

Inclusion

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:
a. History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients. OR
Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of drugs), including:
Interested in being evaluated to undergo DBS, if indicated, to treat medically refractory movement disorder or
Patients already implanted with DBS for continued management

Exclusion

Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications, including but not limited to uncontrolled systemic hypertension with values above 170/100; unstable heart disease; unstable respiratory disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted;
Evidence of secondary or atypical parkinsonism/dystonia/tremor as suggested by:
Dementia as evidenced by formal neuropsychological evaluation, Mattis Dementia Rating Scale (DRS-2) score, and clinical evaluations.
Unable to complete cognitive assessments and testing necessary to adequately evaluate risks and benefits of surgery.
Clinically signficiant or unstable psychiatric disorder such as severe depression or anxiety, which, in the opinion of the investigators would increase the risk of developing postoperative complications.
Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small closed spaces (have claustrophobia), or cannot lie comfortably on their back for up to one hour.
Pregnant women.
Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia
Contra-indications for ongoing stimulation, such as intractable side effects of DBS despite stimulation parameter adjustment

What this trial measures

  • To provide DBS therapy and follow-up managementtwo years

    a. Severity of PD motor symptoms (measured by the UPDRS III scale) b. Changes in dystonia severity (measured by the Burke-Fahn-Marsden (BFM) dystonia rating scale (Burke et al., 1985) c. Changes in tremor severity (measured by the Tremor Rating Scale (TRS)) d. Levels of effective drug therapy for PD patients using the Levodopa Equivalent Drug Dosing (LEDD) e. Changes in behavior, performance of activities of daily living and complications of therapy as measured by the UPDRS I, II, and IV scales 2. To evaluate effects of DBS before and 1 year after surgery on quality of life: a. For PD patients (measured by UPDRS part II and other scales such as the PDQ-39) b. For the Dystonia and ET patients (measured by the SF-12 scale) 3. To evaluate radiographic correlation of DBS electrode position and clinical changes 4. To evaluate neurophysiological mechanisms of DBS and relevant basal ganglia physiology

  • 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 physiologyongoing

    To potentially enroll subjects in other NIH studies.

  • Data collectionongoing

    All the data collected will be an outcome of standard of care and all analyses will be retrospective