Closed-Loop Spinal Cord Stimulation for Chronic Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Saint Francis Hospital
Disqualifiers: Pregnancy, Psychiatric disorders, Active implants, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.
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 data supports the effectiveness of the Evoke Closed-Loop Spinal Cord Stimulation treatment for chronic pain?
Research shows that the Evoke Closed-Loop Spinal Cord Stimulation treatment, which automatically adjusts stimulation based on feedback from the spinal cord, has demonstrated long-term safety and effectiveness in managing chronic pain. Studies have also shown that it can improve sleep quality and reduce the need for opioid medications over time.
12345Is closed-loop spinal cord stimulation (CL-SCS) generally safe for humans?
The Evoke closed-loop spinal cord stimulation system has been evaluated for safety, showing it to be a safe treatment option for chronic pain, with studies indicating it effectively adjusts stimulation in real-time to maintain desired levels without significant safety concerns.
35678What makes the Evoke Closed-Loop Spinal Cord Stimulation treatment unique for chronic pain?
The Evoke Closed-Loop Spinal Cord Stimulation treatment is unique because it uses real-time feedback from the spinal cord to automatically adjust the stimulation level, ensuring consistent pain relief. This closed-loop system is the first of its kind and differs from traditional spinal cord stimulators that do not adjust based on physiological feedback.
125910Eligibility Criteria
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
Be willing and able to comply with study-related requirements, procedures, and visits
I am willing and able to agree to participate in the study.
I am 18 years old or older.
+3 more
Exclusion Criteria
Be concomitantly participating in another clinical study
I do not have a mental health condition that affects my perception of pain or treatment.
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)
+3 more
Trial Timeline
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
Participant Groups
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Spine and Nerve Center of Saint Francis HospitalCharleston, WV
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Who Is Running the Clinical Trial?
Saint Francis HospitalLead Sponsor
Saluda Medical Americas, Inc.Industry Sponsor
References
ECAP-Controlled Closed-Loop Spinal Cord Stimulation Efficacy and Opioid Reduction Over 24-Months: Final Results of the Prospective, Multicenter, Open-Label Avalon Study. [2021]Chronic pain is a major public health concern, as is the associated use of opioid medications, highlighting the importance of alternative treatments, such as spinal cord stimulation (SCS). Here, we present the final 24-month results of the Avalon study, which investigated the use of the first closed-loop SCS system in patients with chronic pain. The system measures the evoked compound action potentials (ECAPs) elicited by each stimulus pulse and drives a feedback loop to maintain the ECAP amplitude near constant.
Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol. [2023]Spinal cord stimulation (SCS) is an established chronic pain treatment, but the effectiveness of traditional, open-loop paradigms has been plagued by variable sustainability in a real-world setting. A new approach, utilizing evoked compound action potential (ECAP) controlled closed-loop (CL) SCS, continuously monitors spinal cord activation and automatically adjusts the stimulation amplitude of every pulse, maintaining stimulation at the prescribed ECAP level through this continual feedback mechanism. Recent studies demonstrated the long-term safety and efficacy of ECAP-controlled CL-SCS. Here, we report the design of a prospective, multicenter, single-arm feasibility study to characterize clinical outcomes in a real-world chronic pain population utilizing ECAP-controlled CL-SCS. Objective neurophysiological measurements such as device performance and patient therapy compliance, will be analyzed against baseline biopsychosocial assessments, to explore the clinical utility of these objective physiologic biomarkers in patient phenotyping.
ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. [2023]The evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is associated with better outcomes when compared with fixed-output, open-loop SCS (OL-SCS) 36 months following implant.
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. [2023]Spinal cord stimulation (SCS) is considered an effective interventional nonpharmacologic treatment option for several chronic pain conditions. Here we present the effects of the novel evoked compound action potential (ECAP) controlled closed-loop (ECAP-CL) SCS system on long-term sleep quality outcomes from the EVOKE study.
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. [2023]The Evoke® spinal cord stimulation (SCS) device enables the closed-loop feedback of dynamically measured evoked compound action potentials (ECAPs) to adjust stimulation amplitude for every stimulation pulse to maintain the stimulation output level near a targeted ECAP amplitude. No other commercially available SCS device presently uses physiologic feedback from the spinal cord to adjust stimulation. Clinicians should be familiar with the differences in devices and with the latest technologies to provide optimized patient care.
First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. [2023]A novel closed-loop spinal cord stimulation (SCS) system has recently been approved for use which records evoked compound action potentials (ECAPs) from the spinal cord and utilizes these recordings to automatically adjust the stimulation strength in real time. It automatically compensates for fluctuations in distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a determined target level. This data collection was principally designed to evaluate the performance of this first closed-loop SCS system in a 'real-world' setting under normal conditions of use in a single European center.
Effective Relief of Pain and Associated Symptoms With Closed-Loop Spinal Cord Stimulation System: Preliminary Results of the Avalon Study. [2022]Conventional spinal cord stimulation (SCS) delivers a fixed-input of energy into the dorsal column. Physiologic effects such as heartbeat, respiration, spinal cord movement, and history of stimulation can cause both the perceived intensity and recruitment of stimulation to increase or decrease, with clinical consequences. A new SCS system controls stimulation dose by measuring the recruitment of fibers in the dorsal column and by using the amplitude of the evoked compound action potentials (ECAPs) to maintain stimulation within an individualized therapeutic range. Safety and efficacy of this closed-loop system was evaluated through six-month postimplantation.
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]Spinal cord stimulation (SCS) is a safe, reversible surgical treatment for complex regional pain syndrome and failed back surgery syndrome refractory to conventional medical management. Paddle electrodes are routinely used for the permanent implant because of the reduced risk of migration, lower energy requirements, and expanded coverage options. The risks associated with paddle lead removal are not well defined in the literature.
Spinal cord stimulation for complex regional pain syndrome. [2020]The therapy of spinal cord stimulation (SCS) is based on producing an electrical field on the dorsal surface of the spinal cord that blocks only neuropathic pain (ie, pain from damage to the nervous system). Most SCS devices deliver a biphasic pulse consisting of a pair of equal amplitude pulses with opposite polarity. SCS therapy is based on the gate control theory of pain and has been used for the treatment of diverse conditions of neuropathic pain, including complex regional pain syndromes (CRPS). In addition to CRPS, SCS is helpful in patients with failed back surgery syndrome, degenerative disk disease, and in patients with peripheral neuropathies. When used in the right patient, SCS provides significant pain relief in a majority of patients with CRPS. This review focuses on the effects of SCS on CRPS. In addition, an overview of the state of the art technologies used for implantable SCS medical devices is also provided.
Less Pain Relief, More Depression, and Female Sex Correlate With Spinal Cord Stimulation Explants. [2022]Spinal cord stimulation (SCS) is a known therapy for a variety of chronic pain conditions, but over time a number of patients proceed to explants.