Ensayos clínicos

Key Inclusion Criteria:

• Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
• Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
• Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

• Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
• Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
• Any other active implanted devices including neurostimulators and /or drug delivery pumps
• Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
• Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
• A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.