Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study (DBS)
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|ClinicalTrials.gov Identifier: NCT01750242|
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : September 17, 2014
Last Update Posted : September 17, 2014
|Condition or disease||Intervention/treatment|
|Parkinson's Disease||Device: Medtronic DBS system|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||OPTIVISE Map Concordance Study in DBS for Parkinson's Disease|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||August 2013|
Parkinson's disease Subjects
Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN).
Device: Medtronic DBS system
Advanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system.
- To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap [ Time Frame: 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.
- Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750242
|United States, California|
|Scripps Clinic, Division of Neurology|
|La Jolla, California, United States, 92037|
|United States, Kansas|
|Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Rajesh Pahwa, MD||Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center|
|Principal Investigator:||Melissa Houser, MD||Scripps Clinic Division of Neurology|