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

Parkinson's Disease Clinical Trial

— DBS  

Official title:

OPTIVISE Map Concordance Study in DBS for Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750242
• Other study ID #: 1669
• Status: Completed
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2024
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center	Kansas City	Kansas
United States	Scripps Clinic, Division of Neurology	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap	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	Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores	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