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Protocol Details

Deep Brain Stimulation Surgery for Movement Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




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


Population Exclusion(s)



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

Recruitment Keyword(s)

Parkinson Disease;
Essential Tremor;
Movement Disorder


Parkinson's Disease;
Essential Tremor;

Investigational Drug(s)


Investigational Device(s)



Procedure/Surgery: Deep Brain Stimulation

Supporting Site

National Institute of Neurological Disorders and Stroke


- 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.


-To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.

-To obtain information on brain and nerve cell function during DBS surgery.


- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia.


-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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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 OR:

Patients with tremor-dominant PD that do not respond to dopaminergic therapy and that exhibit a tremor score of at least 2 for tremor severity on at least one side of the body on the motor UPDRS examination.

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.


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.

Unable to complete cognitive assessments and testing necessary to adequately evaluate risks and benefits of surgery

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 tumor, or stroke, which could cause the movement disorder.

-Features atypical of idiopathic Parkinson s disease.

Dementia as evidenced by formal neuropsychological evaluation and clinical evaluations.

Depression as evidenced by formal neuropsychological evaluation and clinical evaluationss.

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.

Patients with tremor-dominant PD with Scans Without Evidence of Dopaminergic Effect (SWEDD) will be excluded based on clinical and historic information, including DaT functional imaging obtained during routine clinical evaluation of PD as needed.

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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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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

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

Clinical Trials Number:


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