A Study to Evaluate Patient Experience Comparing Tonic vs. Burst Spinal Card Stimulation for Chronic Pain
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-001362
NCT ID: NCT04159753
Sponsor Protocol Number: 19-001362
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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Michael Osborne, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available