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Protocol Details

Deep Brain Stimulation Surgery for Movement Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-N-0211

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Parkinson's Disease;
Deep Brain Stimulation;
Neurophysiology;
Movement Disorder;
Dystonia

Recruitment Keyword(s)

Parkinson Disease;
Essential Tremor;
Movement Disorder

Condition(s)

Parkinson's Disease;
Essential Tremor;
Dystonia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Procedure/Surgery: Deep Brain Stimulation

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

INCLUSION CRITERIA:

To be eligible for entry into the study, candidates must meet all the following criteria:

Be 18 years of age or older.

Able to provide informed consent.

Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy:

- idiopathic PD not adequately controlled with medication or

-primary dystonia that is medically refractory, or

-ET that is not adequately controlled by medications or constitutes a significant functional disability.

EXCLUSION CRITERIA:

Candidates will be excluded if they:

Are unable or unwilling to give informed consent to the research procedures.


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Citations:

de Lau LM, Breteler MM. Epidemiology of Parkinson s disease. Lancet Neurol. 2006 Jun;5(6):525-35.

DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5.

Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kareem A. Zaghloul, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Gretchen C. Scott, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 3D20
10 Center Drive
Bethesda, Maryland 20892
Not Listed
SNBrecruiting@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01581580

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