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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
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Parkinson's Disease;
Deep Brain Stimulation;
Neurophysiology;
Movement Disorder;
Essential Tremor

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 idiopathic PD, primary dystonia, or ET:

The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic

The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movement Disorders Clinic

The diagnosis of ET will be confirmed on clinical examination in the NIH Movement Disorders Clinic (the diagnosis of ET will be based on bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent. Additional or isolated tremor in head may be present but there should be the absence of abnormal posturing).

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.

Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of drugs), including:

--good benefit from dopaminergic medication but associated with insufficient duration of action or unacceptable side-effects OR

--intractable disabling motor fluctuations (severe off periods, dyskinesias, or freezing spells) OR

--intractable symptoms of ET or dystonia impacting at least 2 activities of daily living.

Agree to undergo DBS if indicated to treat medically refractory movement disorder.

EXCLUSION CRITERIA:

Candidates will be excluded if they meet any of the following criteria:

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; active heart disease needing immediate intervention; active respiratory disease needing immediate intervention; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; current or pre-existing life-threatening respiratory disease, such as respiratory failure or ARDS.

Cognitive impairment on Full Scale Intelligence Quotient (FSIQ) portion of Wechsler Adult Intelligence test, which would render the participant unable to provide informed consent or to comply with the study procedures (FSIQ less than 70).

Evidence of secondary or atypical parkinsonism/dystonia/tremor as suggested by:

-History of CVA, exposure to toxins, neuroleptics, or encephalitis

-Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy, or orthostatic hypotension.

-MR-imaging with evidence indicative of secondary disease such as iron deposits in putamen, tumor, or stroke, which could cause the movement disorder.

-Features atypical of idiopathic Parkinson s disease.

Dementia as evidenced by formal neuropsychological evaluation and Mattis Dementia Rating Scale-2 (DRS-2) score below 128.

Depression or anxiety as evidenced by self-report on the Beck Depression Inventory-2 (score above 20) and Beck Anxiety Inventory, respectively.

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


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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

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01581580

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