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Neurostimulation

Spinal Cord Stimulation for Chronic Pain (Neural Panel Trial)

N/A
Recruiting
Research Sponsored by Saluda Medical Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 6-months post-implant
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if measuring certain nerve signals can help in treating chronic pain in the back or limbs.

Who is the study for?
This trial is for adults with chronic pain in the back and/or limbs, including those with failed back surgery syndrome. Participants must have significant pain (≥6 cm on a pain scale), be planning to try the Evoke Spinal Cord Stimulation System, speak English, and can consent to study procedures. Pregnant individuals or those under 18 cannot join.
What is being tested?
The trial is testing the Evoke Spinal Cord Stimulation (SCS) System's ability to use neurophysiological measurements (neural panel metrics) for treating chronic trunk or limb pain through a closed-loop system that adjusts stimulation based on body feedback.
What are the potential side effects?
Potential side effects of SCS may include discomfort at the implant site, unwanted changes in stimulation due to movements, nerve injury, allergic reaction to implanted materials, and infection risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 6-months post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 6-months post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Secondary study objectives
Change in PROMIS-10 Global Health
Change in PROMIS-29+2
Change in Visual Analogue Scale (VAS) Pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ECAP-Controlled, Closed-Loop SCSExperimental Treatment1 Intervention
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evoke Spinal Cord Stimulation (SCS) System
2022
N/A
~10

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Who is running the clinical trial?

Saluda Medical Pty LtdLead Sponsor
8 Previous Clinical Trials
423 Total Patients Enrolled
6 Trials studying Chronic Pain
393 Patients Enrolled for Chronic Pain
~167 spots leftby Feb 2027
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