Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial
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Purpose
The goal of the second phase of the study is to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Procedure: Bilateral Deep Brain Stimulation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CSP #468 Phase II - A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson's Disease, Phase II |
- Blinded assessment of motor function (Unified Parkinson's Disease Rating Scale (UPDRS) Part III) scores in the on stimulation/off medication condition [ Time Frame: at two years ] [ Designated as safety issue: No ]
- Self-reported function, UPDRS scores, quality of life, neurocognitive function, and adverse events [ Time Frame: at two years ] [ Designated as safety issue: No ]
| Enrollment: | 316 |
| Study Start Date: | April 2002 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
STN (Subthalamic Nucleus)
|
Procedure: Bilateral Deep Brain Stimulation
The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial.
|
|
Active Comparator: Arm 2
GPi (Globus Pallidus)
|
Procedure: Bilateral Deep Brain Stimulation
The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial.
|
Detailed Description:
Deep Brain Stimulation (DBS) is a promising therapy for Parkinson's disease (PD) Whether DBS is superior to comprehensive best medical therapy or whether some patients or symptoms respond better to DBS in one area of the brain or the other is currently not known. The goals of this project are to compare the effectiveness of DBS and comprehensive medical therapy as treatments for PD( Phase I) and to compare bilateral DBS at 2 areas of the brain-the subthalamic nucleus (STN) and the globus pallidus (GPi) -to determine the most effective brain site for surgical intervention (Phase II) In this prospective, randomized, multi-center trial, 316 patients will be enrolled at 13 centers over four and a half years. Patients will initially be randomized to immediate surgery (DBS) or to 6 months of "best medical therapy". BMT arm patients will then be randomized to proceed into the DBS surgical phase of the trial. The DBS site (STN pr GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial. Patients will be followed for two years post surgery (24 months for DBS only patients and 30 months for BMT-DBS patients) Effective 8/5/05 randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months. The findings will be critically important in establishing the optimal surgical treatment of the disabling symptoms of PD.
Eligibility| Ages Eligible for Study: | 22 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- idiopathic Parkinson's Disease
- Hoehn and Yahr stage 2 or worse when off medications
- L-dopa responsive with clearly defined "on" periods (i.e. symptoms improve at least partially with L-dopa administration, a characteristic that helps distinguish idiopathic PD from "Parkinson's Plus" and atypical Parkinson's syndromes-see below)
- persistent disabling symptoms (e.g. on troubling dyskinesias, or disabling "off" periods at least 3 hours/day) despite medication therapy. Patients will have been treated with variable doses of levodopa and dopamine agonists (at a minimum) and will have had an adequate trial of other adjunctive medications)
- stable on medical therapy for at least one month prior to study enrollment
- age >21
- available and willing to be followed-up according to study protocol
Exclusion Criteria:
- "Parkinson's plus" syndromes, secondary, or atypical Parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic Parkinson's. These patients have cardinal symptoms characteristic of PD but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to L-dopa, these individuals tend not to improve with standard treatments for PD)
- previous Parkinson's Disease surgery
- medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility)
- contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI)
- active alcohol or drug abuse
- score on Mini-Mental Status examination of 24 or lower, or other neuropsychological dysfunction 9e.g. dementia) that would contraindicate surgery
- intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)
- pregnancy
- concurrent participation in another research protocol
Contacts and Locations| United States, California | |
| University of California at Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| VA Medical Center, San Francisco | |
| San Francisco, California, United States, 94121 | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94121 | |
| VA Greater Los Angeles Healthcare System, West LA | |
| West Los Angeles, California, United States, 90073 | |
| United States, Iowa | |
| VA Medical Center, Iowa City | |
| Iowa City, Iowa, United States, 52246-2208 | |
| United States, Oregon | |
| VA Medical Center, Portland | |
| Portland, Oregon, United States, 97201 | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97207 | |
| United States, Pennsylvania | |
| Philadelphia, OPC | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| University of Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Michael E. DeBakey VA Medical Center (152) | |
| Houston, Texas, United States, 77030 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
| Medical College of Virginia | |
| Richmond, Virginia, United States, 23249 | |
| United States, Washington | |
| VA Puget Sound Health Care System, Seattle | |
| Seattle, Washington, United States, 98108 | |
| Study Chair: | Kenneth Follett | VA Medical Center, Iowa City |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01076452 History of Changes |
| Other Study ID Numbers: | 468 Phase II |
| Study First Received: | February 24, 2010 |
| Last Updated: | July 10, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Parkinson's Disease levo-dopa tremor |
dyskinesia subthalamic nucleus globus pallidus |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 21, 2013