Spinal Cord Stimulation for Chronic Pain

(Neural Panel Trial)

Not currently recruiting at 25 trial locations

Overseen By Angela Leitner, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saluda Medical Pty Ltd

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a spinal cord stimulation system in managing chronic pain in the trunk or limbs. The system features an adjustment mechanism to maintain consistent pain relief. Suitable candidates experience persistent pain in their back or legs, particularly if past surgeries have not provided relief. Participants must communicate in English and adhere to the study's procedures and visits.

As an unphased trial, this study provides patients the chance to explore innovative pain management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Evoke Spinal Cord Stimulation (SCS) System is safe for treating chronic pain?

Research shows that the Evoke Spinal Cord Stimulation (SCS) System is generally safe for treating chronic pain. Studies have demonstrated that clinical testing led to FDA approval, indicating it meets safety standards. In one study involving 134 patients, the system was well-tolerated, with most participants not experiencing serious side effects.

The Evoke SCS System uses special technology that automatically adjusts to maintain steady stimulation, reducing the chances of discomfort or complications. While minor side effects like irritation at the implant site might occur, research supports its overall safety for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Evoke Spinal Cord Stimulation (SCS) System because it offers a new way to manage chronic pain through its ECAP-controlled, closed-loop mechanism. Unlike standard spinal cord stimulators that maintain a fixed level of stimulation, the Evoke SCS System automatically adjusts the stimulation current by measuring and recording evoked compound action potentials (ECAPs) to keep pain relief consistent. This adaptive feature could potentially lead to more precise pain management and improved patient outcomes, giving it an edge over existing options.

What evidence suggests that the Evoke Spinal Cord Stimulation System is effective for chronic pain?

Research shows that the Evoke Spinal Cord Stimulation (SCS) System, which trial participants will receive, effectively treats chronic pain. Studies have found that this system provides lasting pain relief and better overall results for up to three years. It senses the body's nerve signals and automatically adjusts to maintain consistent pain relief. Participants in these studies reported greater pain reduction compared to traditional SCS systems. Additionally, this system has been linked to improved quality of life. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am considering a trial with the Evoke System for my chronic pain in the back or limbs.

Leg pain score ≥ 6 cm (Visual Analog Scale [VAS])

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ECAP-controlled closed-loop spinal cord stimulation to manage chronic pain

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Evoke Spinal Cord Stimulation (SCS) System

Trial Overview 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.

How Is the Trial Designed?

Group I: ECAP-Controlled, Closed-Loop SCS Experimental Treatment 1 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.

Evoke Spinal Cord Stimulation (SCS) System is already approved in United States for the following indications:

Approved in United States as Evoke Spinal Cord Stimulation (SCS) System for:

• Chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain

Who Is Running the Clinical Trial?

Saluda Medical Pty Ltd

Lead Sponsor

Trials

10

Recruited

970+

Published Research Related to This Trial

The Evoke® spinal cord stimulation (SCS) device uses real-time feedback from the spinal cord to adjust stimulation levels, which is a unique feature not found in other commercially available SCS devices.

A systematic review of data over 24 months shows that the Evoke system is both safe and effective for treating chronic intractable pain, providing strong evidence for its clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the Evoke physiologic closed-loop spinal cord stimulation system for the treatment of chronic intractable pain: overview of its safety and efficacy. Poree, L., Foster, A., Staats, PS.[2023]

Spinal cord stimulation (SCS) is recognized as an effective treatment for chronic neuropathic pain, but there is a lack of high-level studies supporting its long-term efficacy, particularly beyond 24 months.

The review highlights significant limitations in current evidence, including concerns about adverse event rates and device explantation, indicating a need for further research to address these issues and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for the treatment of neuropathic pain: expert opinion and 5-year outlook. Malinowski, MN., Jain, S., Jassal, N., et al.[2022]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

A systematic review identified 22 guideline statements for spinal cord stimulation (SCS) in chronic pain treatment from 1998 to 2013, highlighting a need for improved patient selection and therapy durability.

Current guidelines show significant gaps in coverage and evidence synthesis, indicating that updated and more comprehensive guidelines are necessary to enhance patient outcomes and access to neurostimulation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International neuromodulation society critical assessment: guideline review of implantable neurostimulation devices. Deer, TR., Thomson, S., Pope, JE., et al.[2022]

Spinal cord stimulation (SCS) is an effective treatment for chronic pain, particularly in patients with refractory unilateral limb pain syndrome (RULPS), with an initial response rate of 87% that stabilizes at 84% after two years.

A significant portion of patients experienced benefits, including a reduction in pain medication (56%) and a return to work (46.8%), highlighting the importance of careful patient selection and follow-up for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for the treatment of refractory unilateral limb pain syndromes. Kumar, A., Felderhof, C., Eljamel, MS.[2017]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[2022]

Spinal cord stimulation (SCS) is a low-risk, reversible technique that effectively manages chronic, intractable pain when patients are carefully selected, as shown by multicenter prospective studies.

Recent advancements in electrode placement and programmable electronics have enhanced the implementation of SCS, and ongoing innovations are expected to further improve its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for failed back surgery syndrome and other disorders. Nicholson, CL., Korfias, S., Jenkins, A.[2019]

Spinal cord stimulation (SCS) is a safe and effective treatment for chronic pain, increasingly recognized as a first-line therapy due to its non-addictive nature and minimal systemic side effects.

Recent technological advancements, including multi-lead and multi-electrode arrays, have expanded the applications of SCS, allowing for better treatment options for various pain conditions such as radiculitis and complex regional pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future trends in spinal cord stimulation for chronic pain. Deer, TR.[2022]

In a study of 402 patients with chronic pain who received spinal cord stimulation (SCS) devices, 55% of those with lower limb pain and 67% with upper limb pain reported a significant reduction in pain (≥50% reduction) after 2 years, indicating the long-term effectiveness of SCS.

The majority of patients (91%) were satisfied with their treatment, and 93% would choose to undergo the procedure again, while also showing a significant decrease in the need for pain medications, highlighting both the efficacy and safety of SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. Brinzeu, A., Cuny, E., Fontaine, D., et al.[2019]

Spinal Cord Stimulation (SCS) is highly effective for treating chronic leg pain, particularly in patients with neuropathic pain, achieving an 80% success rate in this group.

SCS is less effective for axial pain (lower back pain), indicating that its benefits are primarily seen in limb pain that cannot be treated surgically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic limb pain with spinal cord stimulation. Fogel, GR., Esses, SI., Calvillo, O.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02924129

Safety and Efficacy Study of the Evoke™ SCS System With ... The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8742908/

A Secondary Analysis of the Evoke Randomized Clinical Trial Is a novel closed-loop spinal cord stimulator (SCS) that measures and adjusts to neural response associated with greater pain reduction compared with a fixed- ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37640452/

36-month results of the EVOKE blinded randomized clinical ... ECAP-controlled CL-SCS resulted in sustained, durable pain relief and superior holistic treatment response through 36 months.

4. saludamedical.com saludamedical.com/wp-content/uploads/2024/07/evoke-system-fact-sheet.docx

evoke-system-fact-sheet.docx Developed by Saluda Medical, the Evoke® System is the first and only closed-loop SCS system capable of automatically reading, recording, and responding to the ...

5. centerforpainrelief.com centerforpainrelief.com/evoke-smartscs-system/

Evoke® SmartSCS™ System The EVOKE Study reported industry-leading quality of life outcomes, when compared to current SCS systems, and with 3-year data, has the longest ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190002B.pdf

P190002 SSED - accessdata.fda.gov The Evoke System produces an ECAP amplitude for each stimulus and stores the ECAP amplitudes as histogram data. The ECAP amplitude histograms ...