N/A
Completed N=23
Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study
Source: ClinicalTrials.gov NCT01750242 ↗Enrolled (actual)
23
Serious AEs
—
Results posted
Sep 2014
Primary outcomePrimary: To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap — 86.5 percentage of leads
Summary
To evaluate DBS device settings and match with the features of the DBS care management software.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap |
86.5 | — |
| SECONDARY Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores |
-22.5 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01750242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.