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

NCT01750242 | Completed Results

• 1 other identifier: 1669
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores

  Change from baseline to 18 months

Study Arms (1)

Parkinson's disease Subjects

Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN).

Device: Medtronic DBS system

Interventions

Medtronic DBS system DEVICE

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

Parkinson's disease Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (2)

Scripps Clinic, Division of Neurology

La Jolla, California, 92037, United States

Location

Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Stephanie Salisbury
• Organization: Medtronic Neuromodulation

stephanie.salisbury@medtronic.com

763-526-8096

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 17, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 3, 2024
• Results First Posted: September 17, 2014

Record last verified: 2024-05

Locations

US (2)