Using neurophysiological measurements to guide spinal cord stimulation for chronic pain treatment
A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs.
This study is testing if a new spinal cord stimulation system that uses brain signals can help people with chronic pain in their back and limbs feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saluda Medical Pty Ltd Industry-sponsored |
| Locations | 25 sites (Lake Havasu City, Arizona and 24 other locations) |
| Trial ID | NCT06229470 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical utility of neurophysiological measurements from an ECAP-controlled closed-loop spinal cord stimulation (SCS) system to manage chronic pain in the trunk and limbs. Participants will undergo a temporary trial with the Evoke SCS system, which aims to provide personalized pain relief based on neural panel metrics. The study focuses on patients with significant pain scores related to conditions such as failed back surgery syndrome and intractable low back pain. The goal is to determine how effectively these measurements can guide treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing chronic intractable pain in the trunk or limbs, with significant pain scores.
Not a fit: Patients who do not have chronic pain or those who are not eligible for spinal cord stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized pain management for patients suffering from chronic pain.
How similar studies have performed: While the specific approach of ECAP-controlled closed-loop SCS is novel, similar studies in spinal cord stimulation have shown promising results in managing chronic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain. * Leg pain score ≥ 6 cm (Visual Analog Scale \[VAS\]). * Back pain score ≥ 6 cm (VAS). * Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits. * Subject is not pregnant and not \<18 years of age. Exclusion Criteria: * N/A
Where this trial is running
Lake Havasu City, Arizona and 24 other locations
- Lakeside Spine and Pain — Lake Havasu City, Arizona, United States (Recruiting)
- Spanish Hills Interventional Pain Specialists — Camarillo, California, United States (Active_not_recruiting)
- Pain Consultants of San Diego — La Mesa, California, United States (Recruiting)
- Pacific Research Institute — Santa Rosa, California, United States (Recruiting)
- Boomerang Healthcare — Walnut Creek, California, United States (Recruiting)
- DBPS Research — Greenwood Village, Colorado, United States (Recruiting)
- Pohlman Pain Associates — Delray Beach, Florida, United States (Recruiting)
- Horizon Clinical Research — Jasper, Georgia, United States (Recruiting)
- Rockford Pain Center — Rockford, Illinois, United States (Recruiting)
- Goodman Campbell Brain and Spine — Carmel, Indiana, United States (Recruiting)
- Metro Anesthesia & Pain Management — Des Moines, Iowa, United States (Recruiting)
- Restorative Pain Institute — Louisville, Kentucky, United States (Recruiting)
- Advanced Pain Institute — Hammond, Louisiana, United States (Recruiting)
- Spine and Joint Institute — Glen Burnie, Maryland, United States (Recruiting)
- Michigan Pain Specialists — Ann Arbor, Michigan, United States (Completed)
- Pain Clinic of Michigan — Rochester Hills, Michigan, United States (Recruiting)
- Tricity Research Center, LLC — Grand Island, Nebraska, United States (Recruiting)
- Reno Tahoe Pain Associates — Reno, Nevada, United States (Recruiting)
- Garden State Pain and Orthopedics — Clifton, New Jersey, United States (Recruiting)
- Seaside Clinical Research Institute — Wilmington, North Carolina, United States (Active_not_recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Premier Pain Treatment Institute — Loveland, Ohio, United States (Recruiting)
- Carolinas Center for Advanced Management of Pain — Greenville, South Carolina, United States (Recruiting)
- Institute of Precision Pain Medicine — Corpus Christi, Texas, United States (Recruiting)
- Victoria Pain and Rehabilitation Center — Victoria, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Angela Leitner, MS
- Email: angela.leitner@saludamedical.com
- Phone: 651-208-4223
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.