Evaluating the effectiveness of Evoke® spinal cord stimulation for chronic pain
Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).
This study is testing if the Evoke® spinal cord stimulation can help adults with long-lasting pain that hasn't improved with other treatments feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Francis Hospital Academic / other |
| Locations | 1 site (Charleston, West Virginia) |
| Trial ID | NCT06246526 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) therapy in patients suffering from chronic pain. Participants will be adults diagnosed with chronic, intractable pain that has not responded to conservative treatments for at least six months. The study will collect data on pain levels using a Visual Analog Scale (VAS) to evaluate the therapy's effectiveness over time. The research will be conducted at the Spine and Nerve Center of Saint Francis Hospital in Charleston, West Virginia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic, intractable pain that has not responded to conservative therapy for at least six months.
Not a fit: Patients who are pregnant, nursing, or have other significant medical or psychological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce chronic pain for patients who have not found relief through other treatments.
How similar studies have performed: Other studies have shown promise with spinal cord stimulation therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Charleston, West Virginia
- The Spine and Nerve Center of Saint Francis Hospital — Charleston, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Timothy Deer, MD — Spine and Nerve Center of Saint Francis Hospital
- Study coordinator: Amy Young, RN BSN DMPNA
- Email: amelia.young3@wvumedicine.org
- Phone: 304-347-6144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.