Clinical Trials in the USA / NCT06229470
Active, not recruiting
Not applicable
Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain
NCT06229470 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Chronic Pain
Investigational drug(s) / intervention(s)
Evoke Spinal Cord Stimulation (SCS) System
Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
Study summary
The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.
Eligibility
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
Primary outcome measure(s)
- Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System — through 6-months post-implant
physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Lakeside Spine and Pain | Lake Havasu City | Arizona | |
| Spanish Hills Interventional Pain Specialists | Camarillo | California | |
| Pain Consultants of San Diego | La Mesa | California | |
| Pacific Research Institute | Santa Rosa | California | |
| Boomerang Healthcare | Walnut Creek | California | |
| DBPS Research | Greenwood Village | Colorado | |
| Pohlman Pain Associates | Delray Beach | Florida | |
| Horizon Clinical Research | Jasper | Georgia | |
| Rockford Pain Center | Rockford | Illinois | |
| Goodman Campbell Brain and Spine | Carmel | Indiana | |
| Metro Anesthesia & Pain Management | Des Moines | Iowa | |
| Restorative Pain Institute | Louisville | Kentucky | |
| Advanced Pain Institute | Hammond | Louisiana | |
| Spine and Joint Institute | Glen Burnie | Maryland | |
| Michigan Pain Specialists | Ann Arbor | Michigan | |
| Pain Clinic of Michigan | Rochester Hills | Michigan | |
| Tricity Research Center, LLC | Grand Island | Nebraska | |
| Reno Tahoe Pain Associates | Reno | Nevada | |
| Garden State Pain and Orthopedics | Clifton | New Jersey | |
| Seaside Clinical Research Institute | Wilmington | North Carolina | |
| Cleveland Clinic Foundation | Cleveland | Ohio | |
| Premier Pain Treatment Institute | Loveland | Ohio | |
| Carolinas Center for Advanced Management of Pain | Greenville | South Carolina | |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | |
| Victoria Pain and Rehabilitation Center | Victoria | Texas |
Other trials for the same condition
Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy
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Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)
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Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06229470 on ClinicalTrials.gov ↗ ← All trials in the USA