|
Deep Brain Stimulation Clinical Trial
A Clinical Evaluation of Bilateral Stimulation of the Subthalamic Nucleus 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 medications.
Principal Investigator:
R. Malcolm Stewart, M.D.
Sub-Investigators:
Madhavi Thomas, M.D.
Michael Desaloms, M.D.
Elizabeth Peckham, D.O.
Eric Smernoff, Ph.D.
Kimberly Doyle, Ph.D.
This clinical trial studies the effectiveness and safety of a new deep brain stimulator system in the treatment of advanced Parkinson's disease. All study participants will have the study device surgically implanted.
Eligibility Criteria (this is not a comprehensive list)
Inclusion Criteria
- Person is 18 to 80 years of age
- Person has been diagnosed with Parkinson's Disease for at least five (5) years
- Person experiences at least six (6) 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 medication for at least one month prior to study enrollment
- Person must be available for appropriate follow-up time for the length of the study
Exclusion Criteria
- Person is not a surgical candidate
- Person has any major illness or medical condition that would interfere with participation in the study
- Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker)
- Person has dementia
- Person has a history of seizures
- Person has untreated clinically significant depression
To learn more, call 1-800-725-2732.
|
