TerminatedInterventionalNot ApplicableUpdated Dec 31, 2024
SCS Research Study
Spinal Cord Stimulation Research Study
ClinicalTrials.gov ID
NCT03763708
Lead Sponsor
MedtronicNeuroINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Not Applicable
Enrollment
100Actual
Last Update Posted
Dec 31, 2024Actual
Start Date
Dec 12, 2018Actual
Primary Completion Date
Jan 13, 2023Actual
Completion Date
Jan 13, 2023Actual
Official Title
Spinal Cord Stimulation Research Study
Brief Summary
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
Limb Pain
Trunk Pain
Spinal Cord Stimulation
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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