Safety and Effectiveness Study of the Precision SCS System Adapted for High-Rate Spinal Cord Stimulation

Overview

About this study

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator System Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

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:

  • Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
  • Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
  • Be 22 years of age or older at the time of enrollment
  • Be willing and capable of giving informed consent
  • Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

  • Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
  • Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
  • Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
  • Have a current systemic infection, or local infection in close proximity to anticipated surgical field
  • Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
  • Be participating in another clinical study that may influence the data collected for the study

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

Rochester, Minn.

Mayo Clinic principal investigator

Tim Lamer, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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