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Deep Brain Stimulation Surgery for Movement Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01581580
Recruitment Status : Recruiting
First Posted : April 20, 2012
Last Update Posted : October 15, 2021
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:


- 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Essential Tremor Dystonia Procedure: Deep Brain Stimulation Not Applicable

Detailed Description:


The objective of this protocol is to provide DBS surgery and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in people with medically refractory Parkinson s disease (PD), dystonia, and essential tremor (ET). All treatment under this protocol will be based on the current standard of care for DBS surgery.

Study Population:

Patients 18 years and older with medically refractory PD, dystonia and/or ET may participate in this study.

Study Design

The treatment that is rendered in this protocol is standard of care for PD, dystonia, and ET. Patients confirmed to have medically refractory PD, dystonia or ET will be offered DBS. The therapeutic goal of this procedure is to implant chronically stimulating macroelectrodes in the basal ganglia or thalamic nuclei in order to alleviate the symptoms of PD, dystonia or ET. Pre- and post-operative imaging will be used to precisely localize electrode locations within the brain and will be correlated with measures of clinical efficacy and recorded intra-operative neural activity. Intra-operative microelectrode recordings, as well as micro- and macroelectrode electrical stimulation, will be used to confirm positioning of electrode leads. Intra-operative electrode recordings will also be used to investigate the neurophysiological mechanisms of deep brain stimulation and to explore the neural circuits underlying motor and cognitive processing in the basal ganglia. Intraoperative physiology will be used for clinical and research purposes. Patients will be followed for 3 months after the surgical procedure to determine effectiveness of DBS treatment.

Outcome Measures:

The primary goal of this protocol is to determine the physiology and efficacy of DBS surgery for movement disorders. Efficacy outcome measures include the change in motor symptoms, as measured by the UPDRS III scale, the Burke-Fahn-Marsden (BFM) dystonia rating scale, and the Tremor Rating Scale before and 3 months after treatment. Secondary measures include 1) levels of effective drug therapy before and after surgery; 2) change in behavior and performance of activities of daily living; 3) complications of therapy as measured by the UPDRS I, II, and IV scales before and after surgery and the SF-12 score; 4) radiographic correlation of DBS electrode position and clinical changes; and 5) neurophysiological mechanisms of DBS and motor and cognitive function in the basal ganglia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation Surgery for Movement Disorders
Actual Study Start Date : August 17, 2011
Estimated Primary Completion Date : December 1, 2029
Estimated Study Completion Date : December 1, 2029

Arm Intervention/treatment
treatment arm
patients with Parkinson's Disease, dysonia, and essential tremor
Procedure: Deep Brain Stimulation
standard of care DBS surgery for patients with Parkinson's Disease, dystonia, and essential tremor

Primary Outcome Measures :
  1. physiology and efficacy of DBS surgery for movement disorders [ Time Frame: 3 months ]
    change in UPDRS III scale, Burke-Fahn-Marsden (BFM) scale, and Tremor Rating Scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, Mattis Dementia Rating Scale (DRS-2) score, and clinical evaluations.

Depression or evidenced by self-report on the Beck Depression Inventory-2 (score above 20).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01581580

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Contact: Gretchen C Scott, R.N. Not Listed

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Kareem A Zaghloul, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS) Identifier: NCT01581580    
Other Study ID Numbers: 110211
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: September 13, 2021

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Parkinson's Disease
Deep Brain Stimulation
Movement Disorder
Parkinson Disease
Essential Tremor
Additional relevant MeSH terms:
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Parkinson Disease
Dystonic Disorders
Essential Tremor
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations