Clinical Evaluation of the Infinity DBS System

Overview

About this study

The purpose of this post market study is to support the chronic clinical performance of the Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads, extensions and related system components.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subject is able to provide informed consent;
  • Subjects diagnosed with Parkinson's disease (PD) and have been recommended to receive a DBS implant in the Subthalamic Nucleus (STN) or that have been implanted with an Infinity system in the STN;
  • Subject must be available for follow-up visits.

Exclusion Criteria:

  • Subject is not a surgical candidate;
  • In the Investigator's opinion the subject is unable to tolerate multiple programming sessions within a single setting;
  • Subject is unable to comply with the follow up schedule.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Ryan Uitti, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20345834

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