Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain

Part of paid clinical trials in Carlsbad, California.

Sponsor
MedtronicNeuro
Study ID
NCT05775510
Status
Terminated

Conditions

  • Pain, Chronic
  • Pain, Intractable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Commercially available neurostimulation systems — DEVICE
    Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems

Study Details

Medtronic, Inc. is sponsoring the SENSE SCS clinical study, a prospective, multi-center, post-market, non-randomized, observational study with a hybrid decentralized model of execution, utilizing a mobile application for the collection of patient reported outcomes (PROs). The purpose of the study is to evaluate workflow of a mobile application for collection of PROs and to gather data on patient experience with spinal cord stimulation therapy.

Key Dates

First listed
Mar 20, 2023
Start date
Apr 25, 2023
Status verified
Jan 2026
Primary completion
May 29, 2025
Completion
May 29, 2025

Study Design

Enrollment
91 participants (actual)

Arms

  • Arm: Pilot Phase Cohort
  • Arm: Data at Scale Phase Cohort

Primary Outcome Measure

Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort. [ Time Frame: Up to 28 days ]

Locations (10)

FacilityCityStateZIPSite coordinators
Coastal Research InstituteCarlsbadCalifornia92009-
Pain Management Consultants of Southwest FloridaFort MyersFlorida33907-
Twin Cities Pain ClinicEdinaMinnesota55439-
Garden State Pain and OrthopedicsCliftonNew Jersey07013-
Novant Health Spine SpecialistsWinston-SalemNorth Carolina27103-
Oklahoma Pain ManagementOklahoma CityOklahoma73134-
Pain Diagnostics and Interventional CareSewickleyPennsylvania15143-
North Texas Orthopedics and Spine CenterGrapevineTexas76051-
The San Antonio Orthopaedic GroupSan AntonioTexas78235-
Procura Pain and Spine PLLCShenandoahTexas77384-

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