Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
This study has been completed.
Sponsor:
Advanced Neuromodulation Systems
Information provided by (Responsible Party):
Advanced Neuromodulation Systems
ClinicalTrials.gov Identifier:
NCT00552474
First received: October 31, 2007
Last updated: October 10, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
This is a prospective, controlled, multi-centered, 12 months post-implantation study. A maximum of 12 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 satisfaction scoring.
| Condition | Intervention |
|---|---|
|
Parkinson Disease Movement Disorders |
Device: Libra Deep Brain Stimulation System |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial paroxysmal nonkinesigenic dyskinesia
Perry syndrome
Drug Information available for:
Levodopa
U.S. FDA Resources
Further study details as provided by Advanced Neuromodulation Systems:
Primary Outcome Measures:
- Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 136 |
| Study Start Date: | October 2005 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Group B
Implanted but no active stimulation
|
Device: Libra Deep Brain Stimulation System
Implanted system but no stimulation
Other Name: Libra Deep Brain Stimulation System
|
|
Experimental: Group A
Active Stimulation
|
Device: Libra Deep Brain Stimulation System
Active DBS Therapy
Other Name: Libra Deep Brain Stimulation System
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552474
Locations
| United States, California | |
| Loma Linda University School of Medicine | |
| Loma Linda, California, United States | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States | |
| Universtiy of Miami | |
| Miami, Florida, United States | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| Lahey Clinic | |
| Burlington, Massachusetts, United States | |
| United States, Michigan | |
| Oakwood Hospital | |
| Dearborn, Michigan, United States | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States | |
| Mount Sinai School of Medicine | |
| New York, New York, United States | |
| University of Rochester | |
| Rochester, New York, United States | |
| United States, Ohio | |
| Mayfield Clinic | |
| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
| Pennsylvania Hospital (UPHS) | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Neurology Specialists of Dallas | |
| Dallas, Texas, United States | |
| Baylor College of Medicine | |
| Houston, Texas, United States | |
| United States, Virginia | |
| Univerisity of Virginia | |
| Charlottesville, Virginia, United States | |
| United States, Wisconsin | |
| Medical College of Wisconcin | |
| Milwaukee, Wisconsin, United States | |
Sponsors and Collaborators
Advanced Neuromodulation Systems
Investigators
| Study Director: | DeLea Peichel | ANS |
More Information
Additional Information:
No publications provided
| Responsible Party: | Advanced Neuromodulation Systems |
| ClinicalTrials.gov Identifier: | NCT00552474 History of Changes |
| Other Study ID Numbers: | C-04-01 |
| Study First Received: | October 31, 2007 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Advanced Neuromodulation Systems:
|
Parkinson disease Movement disorders Deep Brain Stimulation Libra l-dopa levodopa |
neuromodulation neurostimulation Electrical stimulation of the brain STN Subthalamic nucleus |
Additional relevant MeSH terms:
|
Movement Disorders Parkinson Disease Central Nervous System Diseases Nervous System Diseases |
Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
