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

May 30, 2024 updated by: MedtronicNeuro

OPTIVISE Map Concordance Study in DBS for Parkinson's Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic, Division of Neurology
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Parkinson's disease patients who have been implanted with the DBS system

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimated)

December 17, 2012

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1669

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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