Deep Brain Stimulation for Movement Disorders

N/A

Recruiting

Led By Debra J Ehrlich, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 18 years of age or older

Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET based on specific criteria

Must not have

Evidence of secondary or atypical parkinsonism/dystonia/tremor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment for people with movement disorders using deep brain stimulation.

Who is the study for?

This trial is for adults over 18 with Parkinson's Disease (PD), essential tremor (ET), or certain dystonias who've had a good response to dopaminergic meds for PD. It's not suitable for those with significant medical risks, secondary movement disorders, dementia, pregnancy, psychiatric issues, or an inability to undergo MRI scans.

What is being tested?

The study tests Deep Brain Stimulation (DBS) therapy in managing movement disorders. Participants will have DBS surgery followed by regular check-ups where the neurostimulator settings are adjusted based on their condition and responses assessed through various physical and cognitive tests.

What are the potential side effects?

Potential side effects of DBS may include headache, infection at the site of surgery or device implantation area, speech problems, balance issues, mood changes and possible complications from brain surgery like bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with Parkinson's, primary dystonia, or essential tremor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unusual or secondary movement disorders like shaking or stiffness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Data collection

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 provide DBS therapy and follow-up management

Secondary study objectives

To access other clinical outcome measures related to response to therapy

To collect physiology data correlated with motor and cognitive function in these

To correlate radiographic data related to DBS electrode position with clinical changes