NCT01218919

Post Market (Brio™ System) Deep Brain Stimulation (DBS) PD Study

A CLINICAL EVALUATION OF A RECHARGEABLE 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 MEDICATION

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 Parkinson's disease that are not adequately controlled with medication. This is the first observational study for the use of the BRIO™ rechargeable constant current device, using a lead with an active electrode tip for deep brain stimulation in Parkinson subjects. The current study was designed to conform to normal medical practices, taking into consideration the current day economic constraints, while assessing the best set of circumstances for the successful sustained reduction of some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.

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 yearly database lock and report, with the subjects being used as their own control. The primary outcome assessment will occur at three months. Following completion of the primary outcome assessment, patients will have an annual visit up to 10 years post implant. Comparison of measures within the same person from pre-treatment to post-treatment will be performed. During the implantation procedure, each subject will undergo a trial of stimulation in the operating room among other potential assessments to determine proper lead placement. The device may be internalized after a successful intra-operative trial or at a later date according to investigator site practice. The date that all components are implanted and programmed will be classified as "Day 0". After system activation the subject will return to clinic for post-operative evaluations at 1 month (+/-14 days), 3 months (+/-14 days), 6 months (+/-14 days) and 12 months (+/-30 days). Thereafter, a long term data collection program will be followed for 10 years post-implant.

Conditions

• Parkinson Disease

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-10-11
• Last updated: 2019-02-04