Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).

Last updated: October 6, 2025
Sponsor: Saint Francis Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Neuropathy

Pain

Treatment

Evoke

Clinical Study ID

NCT06246526
ULTRA Protocol 1.0
  • Ages > 18
  • All Genders

Study Summary

This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Be 18 years of age or older at the time of enrollment.

Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.

Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.

Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.

Be willing and capable of giving informed consent.

Be willing and able to comply with study-related requirements, procedures, and visits.

Exclusion

Exclusion Criteria:

Subject is pregnant or nursing.

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.

Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.

Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).

Have prior experience with SCS.

Be concomitantly participating in another clinical study.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Evoke
Phase:
Study Start date:
January 30, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • The Spine and Nerve Center of Saint Francis Hospital

    Charleston, West Virginia 25301
    United States

    Site Not Available

  • The Spine and Nerve Center of Saint Francis Hospital

    Charleston 4801859, West Virginia 4826850 25301
    United States

    Site Not Available

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