Status:
WITHDRAWN
Post Market (Brio™ System) Deep Brain Stimulation (DBS) PD Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Brief Summary
The objective of this study is to evaluate the effectiveness of a rechargeable Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Park...
Detailed Description
This study is designed as a prospective, observational, non-randomized, multi-centered study for a total of 10 years in duration. It is a 10 year study from system implantation and activation with a y...
Eligibility Criteria
Inclusion
- Subject has signed an informed consent.
- Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
- Subject is a candidate for surgery.
- Subject is 18 to 80 years of age.
- Subject has a history of improvement of Parkinson's symptoms as a direct result of administering L-dopa to the subject with at least a 25% improvement in UPDRS motor score or subject has been diagnosed with tremor-dominant Parkinson's disease.
- Subject should be stable on anti-Parkinson's disease medication for at least one month prior to study enrollment
Exclusion
- Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
- Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities.
- Subject has any condition requiring repeated MRI scans;
- Subject is on anticoagulant medications and is unable to interrupt for time of procedure.
- Subject has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the Informed Consent as determined by the investigator.
- Subject abuses drugs or alcohol.
- Subject has a history of seizure (Neurosurgeon must approve)
- Subject has confirmation of diagnosis of a terminal illness associated with survival \<12 months.
- Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control.
- Subject has participated in a drug, device or biological trial within the preceding 30 days.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01218919
Start Date
October 1 2013
End Date
December 1 2013
Last Update
February 4 2019
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