Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study (DBS)
|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.
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|