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

Last updated: February 6, 2024
Sponsor: Saint Francis Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Pain (Pediatric)

Neuropathy

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 beenrefractory 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 mmindicates the worst imaginable pain) at baseline. Be an appropriate candidate for the surgical procedures required in this study based on theclinical 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 knowncondition 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 apacemaker, 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:
June 30, 2026

Connect with a study center

  • The Spine and Nerve Center of Saint Francis Hospital

    Charleston, West Virginia 25301
    United States

    Active - Recruiting

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