Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).
Recruiting now · Not applicable
Conditions studied: Pain, Chronic Pain, Neuropathic Pain
In brief
This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.
Key facts
- Study ID
- NCT06246526
- Run by
- Saint Francis Hospital
- People needed
- 50
- Starts
- 2024-01-30
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- The Spine and Nerve Center of Saint Francis Hospital — Charleston, West Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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