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

Overview

To evaluate DBS device settings and match with the features of the DBS care management software.

Full Title of Study: “OPTIVISE Map Concordance Study in DBS for Parkinson’s Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 2013

Detailed Description

This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.

Interventions

  • Device: Medtronic DBS system
    • Advanced Parkinson’s disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system.

Arms, Groups and Cohorts

  • Parkinson’s disease Subjects
    • Subjects with advanced Parkinson’s Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN).

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MedtronicNeuro
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rajesh Pahwa, MD, Principal Investigator, Parkinson’s Disease and Movement Disorder Center, University of Kansas Medical Center
    • Melissa Houser, MD, Principal Investigator, Scripps Clinic Division of Neurology

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