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Clinical Evaluation of the Infinity Deep Brain Stimulation System

NCT02989610 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 234

Last updated 2024-08-22

Study results available
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Summary

The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components.

Participants in the PROGRESS study are not assigned to interventional therapy groups. Participants in the PROGRESS study are followed in an observational format as they receive omnidirectional and then directional DBS programming that is part of routine medical care. Data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Omnidirectional stimulation

At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead.

DEVICE

Directional stimulation

At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Alfons Schnitzler, MD · Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience

  • Jan Vesper, MD · Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-08-07
Completion
2022-04-19
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02989610 on ClinicalTrials.gov