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Completed

NCT Number: NCT01750242

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

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Clinic, Division of Neurology, La Jolla, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Medtronic DBS system

Device

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

OPTIVISE Map Concordance Study in DBS for Parkinson's Disease

Acronym: DBS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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