Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Study
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | November 2012 |
| End Date: | July 2013 |
| Contact: | Optivise Clinical Research Study Team |
| Email: | medtronicneurotrials@medtronic.com |
Optivise Map Concordance Study
To evaluate DBS device settings and match with the features of the DBS care management
software.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
We found this trial at
2
sites
Kansas City, Kansas 66160
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