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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750242
First Posted: December 17, 2012
Last Update Posted: September 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedtronicNeuro
  Purpose
To evaluate DBS device settings and match with the features of the DBS care management software.

Condition Intervention
Parkinson's Disease Device: Medtronic DBS system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: OPTIVISE Map Concordance Study in DBS for Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome 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 Outcome 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.


Enrollment: 20
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's disease patients who have been implanted with the DBS system
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)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
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
  More Information

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01750242     History of Changes
Other Study ID Numbers: 1669
First Submitted: December 11, 2012
First Posted: December 17, 2012
Results First Submitted: March 21, 2014
Results First Posted: September 17, 2014
Last Update Posted: September 17, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases