Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study
- Conditions
- Parkinson's Disease
- Interventions
- Device: Medtronic DBS system
- Registration Number
- NCT01750242
- Lead Sponsor
- MedtronicNeuro
- Brief Summary
To evaluate DBS device settings and match with the features of the DBS care management software.
- Detailed Description
This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Patient with Medtronic Deep Brain Stimulation therapy for idiopathic levodopa responsive Parkinson's Disease
- Patient who has had lead placement in the Subthalamic nucleus
- Patient with pre-op MRI available
- Patient with post-op CT scan available showing placement of the lead
- Patient who has documented improvement of at least 35% on UPDRS III scores from baseline preoperative off medication state compared to post DBS implant stimulation on/medications off
- Patient who has had clinically significant persistent stimulation related adverse effects
- Patient who has evidence of lead migration without lead revision
- Patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinson's disease Subjects Medtronic DBS system Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN).
- Primary Outcome Measures
Name Time Method To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap 18 months The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.
- Secondary Outcome Measures
Name Time Method Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores Change from baseline to 18 months The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108.
Trial Locations
- Locations (2)
Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Scripps Clinic, Division of Neurology
🇺🇸La Jolla, California, United States