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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01750242
First received: December 11, 2012
Last updated: September 10, 2014
Last verified: September 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01750242     History of Changes
Other Study ID Numbers: 1669
Study First Received: December 11, 2012
Results First Received: March 21, 2014
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014