Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
Completed · Not applicable
Conditions studied: Parkinson Disease, Movement Disorders
In brief
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.
Key facts
- Study ID
- NCT00552474
- Run by
- Abbott Medical Devices
- People needed
- 136
- Starts
- 2005-10-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2019-02-04
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Loma Linda University School of Medicine — Loma Linda, California, United States
- University of Florida — Gainesville, Florida, United States
- Universtiy of Miami — Miami, Florida, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Lahey Clinic — Burlington, Massachusetts, United States
- Oakwood Hospital — Dearborn, Michigan, United States
- Mount Sinai School of Medicine — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Mayfield Clinic — Cincinnati, Ohio, United States
- Pennsylvania Hospital (UPHS) — Philadelphia, Pennsylvania, United States
- Neurology Specialists of Dallas — Dallas, Texas, United States
- Baylor College of Medicine — Houston, Texas, United States
- Univerisity of Virginia — Charlottesville, Virginia, United States
- Medical College of Wisconcin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.