Closed-Loop Spinal Cord Stimulation for Chronic Pain

(ULTRA Trial)

Overseen By Amy Young, RN BSN DMPNA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saint Francis Hospital

Disqualifiers: Pregnancy, Psychiatric disorders, Active implants, others

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: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment called Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) for individuals with chronic pain. It focuses on those who have experienced severe back or limb pain that has not improved with other treatments for at least six months. Participants must be able to undergo surgery and have a high pain level, as determined by a Visual Analog Scale, which rates pain from 0 to 100. This study may benefit those seeking new options for managing difficult-to-treat pain. As an unphased trial, it offers an opportunity to explore innovative treatment options for chronic pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy is safe for chronic pain patients?

Research has shown that the Evoke Closed-loop Spinal Cord Stimulation (CL-SCS) therapy is generally safe for managing chronic pain. Studies have examined its effectiveness in reducing pain in the body and limbs.

Evidence suggests that patients tolerate this system well. The FDA has approved the Evoke SCS System for treating chronic pain, indicating it meets safety standards.

While no treatment is without risks, current data suggests that the safety of Evoke CL-SCS is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for chronic pain, which often involve conventional spinal cord stimulation or medication, Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy is unique because it actively adjusts in real-time to the body's needs. This therapy uses a closed-loop mechanism that continuously monitors the spinal cord's electrical activity and modifies its stimulation accordingly, aiming for more precise pain control. Researchers are excited about this approach because it has the potential to provide more consistent and personalized pain relief, minimizing the trial-and-error adjustments that are common with current therapies.

What evidence suggests that Evoke® Closed-loop Spinal Cord Stimulation Therapy is effective for chronic pain?

Research has shown that Evoke Closed-loop Spinal Cord Stimulation (CL-SCS) therapy effectively manages chronic pain. One study consistently demonstrated pain relief and improved treatment results over 36 months, with patients experiencing significant relief lasting three years. Another study found that the Evoke closed-loop system reduced pain more effectively than the open-loop version. These findings suggest that Evoke CL-SCS therapy could be a promising option for people with chronic pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Timothy Deer, MD

Principal Investigator

Spine and Nerve Center of Saint Francis Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic, intractable pain of the trunk or limbs that hasn't improved after at least 6 months of treatment. Participants must have a high level of baseline pain and be able to follow study procedures. Pregnant or nursing individuals, those with certain medical conditions, psychological disorders, other active implantable devices, prior SCS experience, or who are in another clinical study cannot join.

Inclusion Criteria

I am willing and able to agree to participate in the study.

Be willing and able to comply with study-related requirements, procedures, and visits

I have had severe, ongoing pain in my body for over 6 months that hasn't improved with treatment.

Exclusion Criteria

Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)

Have prior experience with SCS

Be concomitantly participating in another clinical study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) therapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy

Trial Overview The ULTRA trial is observing how well Evoke Closed-loop Spinal Cord Stimulation (CL-SCS) therapy works on people with chronic pain in real-world settings. It's not testing against another treatment but looking at patient outcomes after receiving this specific intervention.

Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy is already approved in United States for the following indications:

Approved in United States as Evoke 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?

Saint Francis Hospital

Lead Sponsor

Trials

3

Recruited

40+

Saluda Medical Americas, Inc.

Industry Sponsor

Trials

2

Recruited

160+

Published Research Related to This Trial

In a 24-month study involving 50 patients, the Evoke closed-loop spinal cord stimulation (SCS) system demonstrated high efficacy, with 89.5% of patients achieving at least a 50% reduction in pain and 68.4% achieving over 80% reduction by the end of the study.

The use of the Evoke system led to significant improvements in quality of life, function, and sleep, with 82.8% of patients reducing or eliminating their opioid intake, while the need for reprogramming the device decreased to less than once a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ECAP-Controlled Closed-Loop Spinal Cord Stimulation Efficacy and Opioid Reduction Over 24-Months: Final Results of the Prospective, Multicenter, Open-Label Avalon Study. Brooker, C., Russo, M., Cousins, MJ., et al.[2021]

A multicenter feasibility study is underway to evaluate the effectiveness of evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation (CL-SCS) in up to 300 patients with chronic pain, focusing on real-world outcomes over a 24-month period.

This innovative approach continuously adjusts stimulation based on neurophysiological feedback, which may enhance treatment personalization and improve understanding of chronic pain mechanisms, potentially leading to better patient management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol. Leitner, A., Hanson, E., Soliday, N., et al.[2023]

A new closed-loop spinal cord stimulation (SCS) system showed high efficacy in chronic pain management, with 92.6% of subjects reporting at least 50% pain relief for back pain and 91.3% for leg pain at three months post-implantation.

Significant improvements in quality of life and function were observed, with the mechanism of action likely involving feedback control that minimizes the recruitment of pain-related nerve fibers during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Relief of Pain and Associated Symptoms With Closed-Loop Spinal Cord Stimulation System: Preliminary Results of the Avalon Study. Russo, M., Cousins, MJ., Brooker, C., et al.[2022]

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) effectively targets neuropathic pain, particularly in conditions like complex regional pain syndrome (CRPS), providing significant pain relief for many patients when used appropriately.

SCS therapy operates on the gate control theory of pain and utilizes advanced technologies in implantable devices, enhancing its efficacy in treating various neuropathic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for complex regional pain syndrome. Shrivastav, M., Musley, S.[2020]

The novel closed-loop spinal cord stimulation (SCS) system effectively reduced pain intensity in patients with chronic pain, showing significant decreases from a baseline score of 8.4 to 2.0 after 12 months, with 85% patient satisfaction reported.

This real-world study involving 22 patients supports the efficacy of the ECAP-controlled SCS system, maintaining pain relief comparable to results from previous clinical trials, indicating its potential as a reliable treatment option for persistent spinal pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. Nijhuis, HJA., Hofsté, WJ., Krabbenbos, IP., et al.[2023]

In a study of 671 patients with spinal cord stimulation (SCS), 63 patients underwent explantation, with younger age and higher pain levels correlating with higher explant rates, particularly among women.

Women reported significantly more discomfort from the SCS device and were the only group to experience explants in a subset of 114 patients, highlighting the need to explore the physiological and psychosocial factors influencing these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Less Pain Relief, More Depression, and Female Sex Correlate With Spinal Cord Stimulation Explants. Slyer, J., Scott, S., Sheldon, B., et al.[2022]

In the EVOKE study involving 134 patients, the novel evoked compound action potential controlled closed-loop (ECAP-CL) spinal cord stimulation (SCS) system significantly improved sleep quality over 12 months, with 76.4% of patients showing clinically meaningful improvements.

Patients using ECAP-CL SCS not only experienced reduced pain but also achieved better sleep quality scores than the general US population, indicating that this technology may enhance overall well-being in chronic pain sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Long-Term Evoked Compound Action Potential Controlled Closed-Loop Spinal Cord Stimulation on Sleep Quality in Patients With Chronic Pain: An EVOKE Randomized Controlled Trial Study Subanalysis. Costandi, S., Kapural, L., Mekhail, NA., et al.[2023]

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]

In a 36-month study involving participants with chronic pain, ECAP-controlled closed-loop spinal cord stimulation (CL-SCS) resulted in a significantly higher percentage of patients achieving at least a 50% reduction in pain compared to fixed-output open-loop stimulation (OL-SCS) (77.6% vs 49.3%).

CL-SCS not only provided better pain relief but also led to greater improvements in overall quality of life and neural activation without increasing adverse events, indicating its efficacy and safety as a long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Mekhail, NA., Levy, RM., Deer, TR., et al.[2023]

Citations

1. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06246526

Real-World Efficacy of Evoke® Closed-loop Spinal Cord ... This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.

3. rapm.bmj.com rapm.bmj.com/content/early/2023/08/27/rapm-2023-104751

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

4. saludamedical.com saludamedical.com/clinical-evidence2/chronic-trunk-and-or-limb-pain/

Clinical Evidence Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1094715922003695

ID:16250 Two-Year Clinical and QoL Outcomes of the ... A double-blind, randomised, controlled, parallel-arm study compared EVOKE ECAP-controlled, closed-loop SCS (CL) to EVOKE open-loop SCS (OL) at 13 centres in the ...

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10498882/

Cost-utility Analysis of Evoke Closed-loop Spinal Cord ... The results indicate a strong economic case for the use of Evoke CL-SCS in the management of chronic back and leg pain with or without prior spinal surgery.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190002C.pdf

Evoke® SCS System User Manual - accessdata.fda.gov The Evoke SCS System is a closed-loop spinal cord stimulation (SCS) system that is intended to be used to treat chronic pain of the trunk and/or limbs. It ...

9. saludamedical.com saludamedical.com/safety/

Global Safety Information Indications for Use: The Saluda Medical Evoke SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.

10. fda.gov fda.gov/medical-devices/recently-approved-devices/evoke-spinal-cord-stimulation-scs-system-p190002

Evoke Spinal Cord Stimulation (SCS) System – P190002 Evoke SCS is an implanted, rechargeable spinal cord stimulation system intended to treat chronic intractable pain in the trunk or limbs.