Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study

This study is designed as a prospective, observational, non-randomized, multi-centered study for 12 months in duration from implantation with the subjects being used as their own control. The primary outcome assessment will occur at three months: however, subjects will be followed for one year.

A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.

Inclusion criteria

Subjects enrolled in this study must meet the following inclusion criteria:

• 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 Unified Parkinson's Disease Rating Scale (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 criteria

Subjects will be excluded from the study if they meet any of the following criteria:

• 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 has any condition requiring diathermy;
• Subject is on anticoagulant medications and is unable to interrupt for time of procedure.
• Subject has a history of cranial surgery.
• 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
• 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.