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Neurostimulation
ECAP-Controlled, Closed-Loop SCS 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
Neural Panel Trial 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.Check my eligibility
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.See study design
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.
Neural Panel Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 6-months post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 6-months post-implant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Secondary outcome measures
Change in PROMIS-10 Global Health
Change in PROMIS-29+2
Change in Visual Analogue Scale (VAS) Pain
Neural Panel 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
6 Previous Clinical Trials
393 Total Patients Enrolled
6 Trials studying Chronic Pain
393 Patients Enrolled for Chronic Pain
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process currently open for individuals interested in participating in this medical study?
"Indeed, the details on clinicaltrials.gov affirm that this research study is actively seeking participants. Initially shared on March 8th, 2024, and last revised on the same day, the trial aims to enroll 250 patients at a single site."
Answered by AI
What is the current number of participants being admitted to this clinical study?
"Indeed, the information provided on clinicaltrials.gov confirms that patient recruitment is ongoing for this particular study. The trial was first listed on March 8th, 2024 and has been recently updated as of the same date. It aims to enroll a total of 250 patients from one designated site."
Answered by AI
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