NCT02541617

Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Outcomes study to test the hypothesis that patients first identified by community-based neurologists, implanted by a networked movement disorders center, and then managed by the same community-based neurologist will have clinical outcomes comparable to movement disorders centers.

Detailed description

The proposed outcomes study is a prospective, randomized, multicenter, single blind, non-inferiority clinical trial comparing the safety and efficacy of deep brain stimulation therapy applied in a community-based model for 62 subjects with Parkinson's disease appropriate for STN DBS therapy. Eight community-based private neurology practices will be networked to Vanderbilt University Medical Center (VUMC). Neurologists for each practice will attend structured educational programs offered by Medtronic in the identification, selection, and management of Parkinson's disease patients with DBS therapy. Following this educational program, each practice will identify subjects for implantation VUMC. Following screening and baseline visits at VUMC, appropriate patients will be implanted with bilateral subthalamic nucleus deep brain stimulating therapy. The initial post-operative programming will be done at VUMC four weeks after implantation. 8 subjects will then be equally randomized with half being followed for long-term management by the community-based neurologist. The other half will be followed at VUMC. All subsequent outpatient evaluation management of medications and deep brain stimulation will be managed per standard of care at the location assigned by randomization, community-based private neurology practice or VUMC. All subjects will be enrolled during the first 24 months of the study. Follow-up evaluations at 12 months will be performed at VUMC. Each patient identified by the community-based neurologist for implantation will be assessed at VUMC. This assessment will include a videotaped off and on UPDRS III rating, neuropsychological testing, and appropriateness as outlined in the patient selection educational program. Patients will be implanted by bilateral subthalamic nucleus deep brain stimulation therapy within 120 days of their initial assessment. The initial post-operative programming will be performed four weeks post-operatively, this is all standard of care. Subjects will then be randomized to be either managed by their community-based neurologist or at VUMC. Follow-up evaluations at 12 months will include a videotaped on and off UPDRS rating and neuropsychological testing, anti-parkinson medication dosages, and quality of life measures.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
PROCEDURE	Programming by community Neurologist	Deep Brain stimulator with be programmed by a community Neurologist
PROCEDURE	Standard of care	Deep Brain Stimulator will be programmed with at the implanting movement disorders center

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-02-01
• Completion: 2018-02-01
• First posted: 2015-09-04
• Last updated: 2017-04-27