RecruitingNot ApplicableNCT02119611

Deep Brain Stimulation Therapy in Movement Disorders


Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Enrollment

300 participants

Start Date

Apr 2, 2014

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is researching deep brain stimulation (DBS) — a procedure where small electrical devices are surgically placed in the brain to send signals that help reduce abnormal movements — for people with Parkinson's disease, dystonia (a condition causing abnormal, sustained muscle contractions and abnormal postures), or essential tremor (persistent, uncontrollable shaking of the hands or head). **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of Parkinson's disease, primary dystonia, or essential tremor - For Parkinson's disease: your motor symptoms have not improved enough with medication, or you have persistent tremor despite treatment - Your symptoms are significantly impacting your quality of life despite optimal medication adjustments - You are physically and mentally able to cooperate with the study procedures **You may NOT be eligible if...** - Your symptoms are adequately controlled with current medications - You have serious medical or psychiatric conditions that would make brain surgery unsafe or interfere with study results - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT02119611


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