Trials / Active Not Recruiting
Active Not RecruitingNCT06229470
Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain
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.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Saluda Medical Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2024-03-08
- Primary completion
- 2027-02-28
- Completion
- 2027-02-28
- First posted
- 2024-01-29
- Last updated
- 2026-03-30
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06229470. Inclusion in this directory is not an endorsement.