Status:
TERMINATED
SCS Research Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Limb Pain
Trunk Pain
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
Eligibility Criteria
Inclusion
- 22 years of age or older
- Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
- Willing and able to provide signed and dated informed consent
- Capable of comprehending and consenting in English
- Willing and able to comply with all study procedures, including diary completion, and visits
- Able to differentiate between pain associated with the indication for SCS implant and other types of pain
Exclusion
- Implanted with neurostimulation system for an off-label indication
- Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
- If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
- Has untreated major psychiatric comorbidity
- Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03763708
Start Date
December 12 2018
End Date
January 13 2023
Last Update
December 31 2024
Active Locations (9)
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1
Center for Pain and Supportive Care
Phoenix, Arizona, United States, 85028
2
Goodman Campbell Brain and Spine
Carmel, Indiana, United States, 46032
3
Drez One
Somerset, Kentucky, United States, 42503
4
Twin Cities Pain Clinic
Edina, Minnesota, United States, 55439