A Study to Evaluate Patient Experience Comparing Tonic vs. Burst Spinal Card Stimulation for Chronic Pain

Overview

About this study

The purpose of this study is to evaluate if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation

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:

  • Subjects that have implanted Eon Mini™ tonic SCS for a minimum period of 2 years.
  • Subjects must be at least 18 years of age.

Exclusion Criteria:

  • Subject’s overall Beck Depression Inventory II Score is >24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; If subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they should be subjects to Baker’s act.
  • Subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation.
  • Subject has an infusion pump or any other implantable neurostimulator device.
  • Subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment.
  • Subject's pain originates from peripheral vascular disease
  • Subject is immunocompromised.
  • Subject has a documented history of substance abuse.(narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection.
  • Subject has history of cancer requiring active treatment in the last 6 months.

 

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 Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Michael Osborne, M.D.

Open for enrollment

Contact information:

Michael Osborne M.D.

(904)953-7246

osborne.michael@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20471586

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