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

This study is currently recruiting participants.
Verified March 2013 by MedtronicNeuro
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01750242
First received: December 11, 2012
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • To characterize the percentage of leads where the target map and the clinically-derived activation map overlap [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in UPDRS III scores from baseline to follow-up. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: November 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with advanced Parkinson's disease
Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system
 Device: Medtronic DBS system
Patients implanted with the Medtronic DBS system due to their advanced Parkinson's disease

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750242

Contacts
Contact: Optivise Clinical Research Study Team medtronicneurotrials@medtronic.com

Locations
United States, California
Scripps Clinic, Division of Neurology Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Melissa Houser, MD            
United States, Kansas
Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Rajesh Pahwa, MD            
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
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013