Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
1999-06-30
2009-06-30
Brief Summary
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Detailed Description
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The major aim of this 5-year study is to carry out a prospective, double blinded, randomized, clinical trial of DBS for medically intractable PD. The study will evaluate the effect of DBS in the Gpi and STN on motor, neuropsychological and psychiatric function, and quality of life in patients with PD. The study also will address two key issues: 1) whether there are differences between unilateral Gpi-DBS and STN-DBS and 2) which patients are the best candidates for bilateral DBS.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SA #1 Arm 1: Unilateral DBS in GPi
deep brain stimulation
Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
SA #1 Arm 2: Unilateral DBS in STN
deep brain stimulation
Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
SA #2 Arm 1: Bilateral DBS in GPi
Patients with GPi bilateral DBS (previously had unilateral DBS in the GPi, now have bilateral DBS in GPi)
deep brain stimulation
Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
SA #2 Arm 2: Bilateral DBS in STN
Patients with STN bilateral DBS (previously had unilateral DBS in the STN, now have bilateral DBS in STN)
deep brain stimulation
Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
Interventions
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deep brain stimulation
Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hoeh \& Yahr staging III or worse "off " medication periods.
* Intractable, disabling motor fluctuations, dyskinesias, or freezing episodes.
* Unsatisfactory clinical response to maximal medical management or previous surgical treatment.
* Stable on Parkinson's medications for at least 30 days with total L-dopa equivalence varying no more than +/- twenty percent during the 30 day period.
* Absence of cognitive, or psychiatric or other co-morbidities that might interfere with the patient's ability to understand and sign the informed consent form.
EXCLUSION:
* Clinically significant medical history that increases pre- / post operative complications (Cardiac or pulmonary disease, uncontrolled hypertension, diabetes…).
* Secondary or atypical parkinsonism as suggested by: i. History of stroke, encephalitis, exposure to toxins or neuroleptics. ii. Neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction. iii. MRI scan with evidence of significant brain atrophy, lacunar infracts, or iron deposits in the putamen.
* Dementia as indicated by a Mattis Dementia Rating Scale (DRS) less than 116 or DSM-IV criterion for dementia.
* Clinically significant psychiatric disorder meeting Structured Clinical Interview for the DSM-IV criteria for an active anxiety, depressive, or psychotic disorder.
30 Years
75 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Jerrold L Vitek, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Foundation, Director - Functional Neuroscience Research Center
Mahlon R. DeLong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University School of Medicine, Neurology Department
Atlanta, Georgia, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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Other Identifiers
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