Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Timothy Furnish (ucsd)
Headshot of Timothy Furnish
Timothy Furnish

Description

Summary

To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.

Official Title

Spinal Cord Stimulation Research Study

Details

This post market study will measure the following: - Numeric Pain Rating Scale - Satisfaction and Stimulation Assessment - Stimulation feedback - Stimulation parameters - Anatomical locations of active contacts - Stimulation thresholds - Location of paresthesia - Oswestry Disability Index - European Quality of Life 5-Dimensions - To characterize non-invasive health monitoring data

Keywords

Limb Pain Trunk Pain Spinal Cord Stimulation

Eligibility

You can join if…

Open to people ages 22 years and up

  1. 22 years of age or older
  2. 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
  3. Willing and able to provide signed and dated informed consent
  4. Capable of comprehending and consenting in English
  5. Willing and able to comply with all study procedures, including diary completion, and visits
  6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain

You CAN'T join if...

  1. Implanted with neurostimulation system for an off-label indication
  2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
  3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
  4. Has untreated major psychiatric comorbidity
  5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator

Locations

  • University of California San Diego Altman Clinical and Translational Research Institute not yet accepting patients
    La Jolla California 92093 United States
  • Center for Pain and Supportive Care accepting new patients
    Phoenix Arizona 85028 United States

Lead Scientist at University of California Health

  • Timothy Furnish (ucsd)
    Clinical Professor, Anesthesiology, Vc-health Sciences-schools. Authored (or co-authored) 30 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
MedtronicNeuro
ID
NCT03763708
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated