Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
January 31, 2019 updated by: Abbott Medical Devices
A Clinical Evaluation of Bilateral Stimulation of the Subthalamic Nucleus (STN) Using the ANS Totally Implantable Deep Brain Stimulation System as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication.
The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease that are not adequately controlled with medication.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, controlled, multi-centered, 12 months post-implantation study. A maximum of 15 sites will enroll a total of 136 patients.
All study participants will have the study device surgically implanted. After implant surgery, study participants will return to the clinic for evaluation 30 days after surgery, three months after surgery, six months after surgery and twelve months after surgery. At the baseline, three, six and twelve month visits the patient's Parkinson's symptoms and ability to perform daily activities will be evaluated using a number of accepted assessment tools including a Dyskinesia diary, evaluation of PD symptoms, quality of life scoring and patient extension study to monitor the safety and efficacy of the ANS Libra/Libra Deep Brain Stimulation System.
After the 1 year study, patients may enter another protocol (C-06-04) to continue to monitor the safety and efficacy of the Libra Deep Brain Stimulation System. Patients may be followed for an additional 4 years.
If necessary, patients may continue to have access to the investigational device under protocol (C-13-02) which allows for compassionate use access to it.
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Loma Linda, California, United States, 92354
- Loma Linda University School of Medicine
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Miami, Florida, United States, 33136
- Universtiy of Miami
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-
Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Lahey Clinic
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Michigan
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Dearborn, Michigan, United States, 48124
- Oakwood Hospital
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Rochester, New York, United States, 14618
- University of Rochester
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Ohio
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Cincinnati, Ohio, United States, 45267
- Mayfield Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital (UPHS)
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Texas
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Dallas, Texas, United States, 75231
- Neurology Specialists of Dallas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Virginia
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Charlottesville, Virginia, United States, 22903
- Univerisity of Virginia
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconcin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Person is 18 to 80 years of age
- Person has been diagnosed with Parkinson's disease for at lease five (5) years
- Person experiences at least six (6) hours or more daily "off-time" or moderate to severe dyskinesias during waking hours
- Person has a history of improvement of Parkinson's symptoms with l-dopa (levodopa) therapy
- Person must be willing to maintain a constant dose of anti-Parkinson's disease medication for at least one month prior to study enrollment
- Person must be available for appropriate follow-up times for the length of the study
Exclusion Criteria:
- Person has any major illness or medical condition that would interfere with participation in the study
- Person currently suffers from untreated, major depression
- Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker)
- Person has had a prior surgery for the treatment of PD symptoms, including previous DBS surgery
- Person has dementia
- Person has a history of seizures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Group B
Implanted but no active stimulation
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Active DBS Therapy
Implanted system but no stimulation
|
|
Experimental: Group A
Active Stimulation
|
Active DBS Therapy
Implanted system but no stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in the following over time: Incidence of AEs; UPDRS motor scores; Activities of Daily Living; Quality of Life, Quality Sleep Index, Hoehn and Yahr Staging, Global Outcome evaluation and Patient Satisfaction
Time Frame: 1 year
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy
Time Frame: Yearly for 5 years
|
Reduction in Parkinson's symptoms as demonstrated by the total UPDRS scores and each individual component of the UPDRS in the medication on and off state with stimulation on at 2 years, 3 years, 4 years, and 5 years.
|
Yearly for 5 years
|
|
Quality of life
Time Frame: up to to 5 years
|
Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39)
|
up to to 5 years
|
|
Activites of Daily Living
Time Frame: up to 5 years
|
Activities of Daily Living measurement at 2 years, 3 years, 4 years, and 5 years as determined from the Unified Parkinson's Disease Rating Scale (UPDRS) in the medication on and stimulation on state
|
up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: DeLea Peichel, ANS/St Jude Medical
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
October 31, 2007
First Submitted That Met QC Criteria
October 31, 2007
First Posted (Estimate)
November 2, 2007
Study Record Updates
Last Update Posted (Actual)
February 4, 2019
Last Update Submitted That Met QC Criteria
January 31, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-04-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.