Studies for Parkinson's Disease patients with Dyskinesia

Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (INTREPID)

Purpose: The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Duration: 52 weeks

Study Design: Randomized, Double Blind, Active Comparator (Medium continuous dose of stimulation), Sham Comparator (Low intermittent dose of stimulation)

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.

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.

Last modified: Feb 01, 2016