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Deep Brain Stimulation Surgery for Movement Disorders

Primary Purpose

Parkinson's Disease, Essential Tremor, Dystonia

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Deep Brain Stimulation, Neurophysiology, Movement Disorder, Dystonia, Parkinson Disease, Essential Tremor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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 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.

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.

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.

Sites / Locations

  • National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

treatment arm

Arm Description

patients with Parkinson's Disease, dysonia, and essential tremor

Outcomes

Primary Outcome Measures

physiology and efficacy of DBS surgery for movement disorders
change in UPDRS III scale, Burke-Fahn-Marsden (BFM) scale, and Tremor Rating Scale

Secondary Outcome Measures

Full Information

First Posted
April 19, 2012
Last Updated
October 18, 2023
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01581580
Brief Title
Deep Brain Stimulation Surgery for Movement Disorders
Official Title
Deep Brain Stimulation Surgery for Movement Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2, 2023
Overall Recruitment Status
Suspended
Why Stopped
Study on hold at the direction of the IRBO; use of the subdural cortical electrodes should be submitted to the FDA for a formal risk determination.
Study Start Date
August 17, 2011 (Actual)
Primary Completion Date
December 1, 2029 (Anticipated)
Study Completion Date
December 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
Objective: The objective of this protocol is to collect prospective physiology 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 characterize motor and cognitive function in people receiving standard of care DBS surgery for movement disorders. Secondary measures include 1) radiographic correlation of DBS electrode position and clinical changes; and 2) neurophysiological mechanisms of DBS and motor and cognitive function in the basal ganglia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Essential Tremor, Dystonia
Keywords
Parkinson's Disease, Deep Brain Stimulation, Neurophysiology, Movement Disorder, Dystonia, Parkinson Disease, Essential Tremor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Other
Arm Description
patients with Parkinson's Disease, dysonia, and essential tremor
Intervention Type
Procedure
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
standard of care DBS surgery for patients with Parkinson's Disease, dystonia, and essential tremor
Primary Outcome Measure Information:
Title
physiology and efficacy of DBS surgery for movement disorders
Description
change in UPDRS III scale, Burke-Fahn-Marsden (BFM) scale, and Tremor Rating Scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kareem A Zaghloul, M.D.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16713924
Citation
de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
Results Reference
background
PubMed Identifier
1695404
Citation
DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v.
Results Reference
background
PubMed Identifier
1695401
Citation
Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.
Results Reference
background
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2011-N-0211.html
Description
NIH Clinical Center Detailed Web Page

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Deep Brain Stimulation Surgery for Movement Disorders

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