RecruitingNot ApplicableNCT01581580

Deep Brain Stimulation Surgery for Movement Disorders


Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Enrollment

200 participants

Start Date

Aug 17, 2011

Study Type

INTERVENTIONAL

Conditions

Summary

Background: \- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery. Objectives: * To study how DBS surgery affects Parkinson s disease, dystonia, and tremor. * To obtain information on brain and nerve cell function during DBS surgery. Eligibility: \- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia. Design: * Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests. * During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier. * After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings. * Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is following people with movement disorders — such as Parkinson's disease or dystonia (uncontrolled muscle contractions) — who undergo deep brain stimulation (DBS) surgery, which uses implanted electrodes to send electrical signals to specific parts of the brain to reduce symptoms. **You may be eligible if...** - You are 18 or older and can provide informed consent - You have been diagnosed with Parkinson's disease that is not adequately controlled with medications, or with primary dystonia (a movement disorder causing involuntary muscle contractions) - A specialist team at the NIH movement disorders clinic has reviewed your case and determined that DBS surgery is appropriate for you **You may NOT be eligible if...** - Your movement disorder does not meet the criteria for DBS surgery as assessed by the specialist team - You are unable to provide informed consent - You are under 18 years old 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

DEVICEMedtronic Activa Tremor Control System

Medtronic DBS Therapy delivers electrical stimulation to an area in the brain to help treat Parkinson's Disease, dystonia, and essential tremor.

PROCEDUREDeep Brain Stimulation

standard of care DBS surgery for patients with Parkinson's Disease, dystonia, and essential tremor


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01581580


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