Spinal Cord Stimulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen ByChet Moritz, Ph.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a treatment that uses electrical signals sent through the skin to help people with spinal cord injuries improve arm movement and reduce muscle stiffness. The treatment involves placing electrodes on the neck and using sensors to detect movement. The goal is to see if this method can better help patients regain function and reduce stiffness.
Will I have to stop taking my current medications?
The trial requires that participants do not take certain medications, specifically tizanidine, dantrolene, or diazepam. If you are taking these, you would need to stop before participating.
What data supports the effectiveness of the treatment Closed-loop Stimulation for Spinal Cord Injury?
Closed-loop spinal cord stimulation (SCS) has shown effectiveness in treating chronic pain by automatically adjusting stimulation based on real-time feedback from the spinal cord, which helps maintain consistent therapeutic effects. This approach has been successful in managing pain and could potentially be adapted to help restore function after spinal cord injury, as it allows for precise control of stimulation and compensates for changes in the body.
12345Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is considered a safe and reversible treatment for conditions like chronic pain, with studies showing it can be used effectively in real-world settings. However, the risks associated with certain procedures, like paddle electrode removal, are not well defined in the literature.
15678How does the closed-loop spinal cord stimulation treatment differ from other treatments for spinal cord injury?
Closed-loop spinal cord stimulation is unique because it automatically adjusts the strength of electrical pulses in real-time based on feedback from the spinal cord, ensuring consistent stimulation despite changes in posture or activity. This approach contrasts with traditional open-loop systems that use fixed settings, which can lead to inconsistent results.
13459Eligibility Criteria
This trial is for adults with a stable medical condition who have had a cervical spinal cord injury at least one year ago, can perform simple motor tasks, and attend sessions three times weekly. They must not be ventilator-dependent or have certain implants, drug abuse history, pregnancy, severe allergies, or other conditions that could interfere with the study.Inclusion Criteria
I struggle with daily tasks like dressing or feeding due to hand issues.
My heart and lung health allows me to do arm exercises.
I have a spinal cord injury above my shoulders and still have some movement or sensation below the injury.
I can attend training and assessment sessions 3 times a week.
Exclusion Criteria
I have a history of neurological diseases like stroke or MS.
I have nerve damage in my hands or feet.
I do not have any unhealed injuries or frequent infections that could affect my arm rehabilitation.
I am currently taking tizanidine, dantrolene, or diazepam.
I have had botulinum toxin injections in my arm muscles within the last 6 months.
I have had surgery to move tendons or nerves in my arm or hand.
I rely on a machine to help me breathe.
I have a history of chronic headaches or migraines.
I have cancer.
I have a rheumatic disease like rheumatoid arthritis or lupus.
I have a heart or muscle condition that stops me from fully joining in physical therapy.
I have or had syringomyelia with symptoms like pain, weakness, sensory loss, or issues with bowel/bladder.
I do not have uncontrolled high blood pressure or serious heart, lung, or blood clotting issues.
My spinal cord injury is due to an autoimmune disease.
I have a history of seizures or am at high risk for seizures.
Participant Groups
The study tests non-invasive closed-loop electrical stimulation versus open-loop stimulation to improve hand function and reduce spasticity after spinal cord injuries. Participants will also engage in functional task practice as part of their therapy regimen.
2Treatment groups
Experimental Treatment
Group I: Open-loop StimulationExperimental Treatment2 Interventions
Continuous stimulation
Group II: Close-loop StimulationExperimental Treatment2 Interventions
Intended movement-based stimulation.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of WashingtonSeattle, WA
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Who is running the clinical trial?
University of WashingtonLead Sponsor
References
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.
Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]Spinal cord stimulation (SCS) is an approved treatment for intractable pain and has recently emerged as a promising area of research for restoring function after spinal cord lesion. This review will focus on the historical evolution of this transition and the path that remains to be taken for these methods to be rigorously evaluated for application in clinical practice. New developments in SCS are being driven by advances in the understanding of spinal cord lesions at the molecular, cellular, and neuronal levels, as well as the understanding of compensatory mechanisms. Advances in neuroengineering and the computational neurosciences have enabled the development of new conceptual SCS strategies, such as spatiotemporal neuromodulation, which allows spatially selective stimulation at precise time points during anticipated movement. It has also become increasingly clear that these methods are only effective when combined with intensive rehabilitation techniques, such as new task-oriented methods and robotic aids. The emergence of innovative approaches to spinal cord neuromodulation has sparked significant enthusiasm among patients and in the media. Non-invasive methods are perceived to offer improved safety, patient acceptance, and cost-effectiveness. There is an immediate need for well-designed clinical trials involving consumer or advocacy groups to evaluate and compare the effectiveness of various treatment modalities, assess safety considerations, and establish outcome priorities.
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.
Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. [2020]Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spinal cord activation in response to therapy via recorded evoked compound action potentials (ECAPs) in patients during daily use. These ECAPs are also used to optimise programming and deliver closed-loop spinal cord stimulation by adjusting the stimulation current to maintain activation within patients' therapeutic window. We aimed to examine pain relief and the extent of spinal cord activation with ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation for the treatment of chronic back and leg pain.
A New Direction for Closed-Loop Spinal Cord Stimulation: Combining Contemporary Therapy Paradigms with Evoked Compound Action Potential Sensing. [2022]Spinal cord stimulation (SCS) utilizes the delivery of mild electrical pulses via epidural electrodes placed on the dorsal side of the spinal cord, typically to treat chronic pain. The first clinical use of SCS involved the delivery of paresthesia inducing, low-frequency waveforms to the neural targets corresponding to the painful areas. Contemporary SCS therapies now leverage novel therapeutic pathways to limit paresthesia and deliver superior clinical outcomes. Historically, SCS has largely been delivered with fixed stimulation parameters. This approach, referred to as open-loop (OL) SCS, does not account for the fluctuations in spacing-driven by postural changes and activity-between the electrodes and the cord. These fluctuations result in variability in the delivered dose and the volume of tissue activation (VTA) that manifests with each stimulation pulse. Inconsistent dosing may lead to suboptimal therapeutic efficacy and durability. To address this clinical need, closed-loop (CL) SCS systems have been developed to automatically adjust stimulation parameters to compensate for this variability. The evoked compound action potential (ECAP), a biopotential generated by the synchronous activation of dorsal column fibers, is indicative of the VTA resulting from the stimulation pulse. The ECAP may be utilized as a control signal in CL SCS systems to adjust stimulation parameters to reduce variability in the ECAP, and in turn, variability in the VTA. While investigational CL SCS systems with ECAP sensing have so far focused solely on managing paresthesia-based SCS, such systems must also incorporate the stimulation approaches that now define the contemporary clinical practice of SCS. Accordingly, we describe here a flexible, next-generation framework for neural responsive SCS that blends science-based methodologies for pain management with real-time CL control for biophysical variation. We conclude with a clinical example of such a system and the associated performance characteristics.
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.
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.
Postural Changes in Spinal Cord Stimulation Thresholds: Current and Voltage Sources. [2023]Spinal cord stimulation (SCS) thresholds are known to change with body position; however, these changes have not been fully characterized for both "constant-voltage" and "constant-current" pulse generators. This study aimed to evaluate and quantify changes in psychophysical thresholds resulting from postural changes that may affect both conventional paresthesia-based SCS and novel paresthesia-free SCS technologies.
Development of an Activity-Dependent Epidural Stimulation System in Freely Moving Spinal Cord Injured Rats: A Proof of Concept Study. [2020]Purpose: Extensive pre-clinical and clinical experimentation has yielded data on the robustness and versatility of epidural stimulation (ES) strategies to activate spinal neural circuitry to produce functional benefits. Increasing studies are now reporting that closed-loop electrical stimulation delivery methods significantly enhance the neuromodulation effects of stimulation, to in turn, improve physiological outcomes of the intervention. No studies have yet explored the feasibility and usage of closed-loop systems to neuromodulate the cervical spinal cord using ES. Methods: We developed an activity-dependent system that utilizes electromyography (EMG) activity to trigger epidural stimulation (tES) of the cervical spinal cord in awake, freely moving rats. Experiments were performed on rats that were implanted with chronic forelimb EMG and cervical epidural implants, with (n = 7) and without (n = 2) a complete C4 spinal hemisection. Results: Our results show that the EMG triggered activity-dependent system can be reliably applied and reproduced for: (i) stimulating multiple rats simultaneously throughout the night during free home-cage activity and (ii) use as a mobile system for testing and training during various short-term behavioral testing conditions. The system was able to consistently generate stimulation pulse trains in response to attempted EMG activity that crossed a user-defined threshold in all rats for all experiments, including the overnight experiments that lasts for 7 h/session for 6 days/week through the 3-month period. Conclusion: The developed closed-loop system can be considered to represent a class of bidirectional neural prostheses via a circuit that enables two-way interactions between neural activity (real-time processing of EMG activity) and external devices (such as a stimulator). It can operate autonomously for extended periods of time in unrestrained rats, allowing its use as a long-term therapeutic tool. It can also enable us to study the long-term physiological effects of incorporating electrical stimulation techniques into the nervous system. The system can also be experimented for connecting several neural systems into a Brainet by combining neural signals from multiple rats dynamically and in real-time so as to enhance motor performance. Studies are ongoing in our laboratory to test the usefulness of this system in the recovery of hand function after cervical spinal cord injuries.