Spinal Cord Stimulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen ByAlexander Ovechkin, MD, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Louisville
No Placebo Group
Trial Summary
What is the purpose of this trial?Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.
How does the treatment Spinal Cord Stimulation for Spinal Cord Injury differ from other treatments?
This treatment is unique because it uses electrical stimulation of the spinal cord to improve respiratory function, which is not typically addressed by other treatments for spinal cord injury. It combines respiratory muscle training with spinal cord stimulation to enhance breathing and coughing abilities, offering a novel approach to address respiratory impairments in patients with spinal cord injuries.
13789Is spinal cord stimulation generally safe for humans?
Research on spinal cord stimulation, including studies on animals and humans, suggests it can be safe and beneficial for improving respiratory function and muscle strength after spinal cord injury. However, more research is needed to confirm long-term safety and effectiveness.
13789What data supports the effectiveness of the treatment Spinal Cord Stimulation for Spinal Cord Injury?
Research shows that respiratory muscle strength training can improve muscle strength by up to 50% in people with spinal cord injuries. Additionally, combining transcutaneous spinal cord stimulation with inspiratory muscle training significantly improved breathing abilities in individuals with cervical spinal cord injuries.
24568Will 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.
Eligibility Criteria
This trial is for adults over 18 with stable, non-progressive spinal cord injuries between C3-T1, who have had the injury for at least two years and have a significant deficit in lung function. It's not suitable for those with severe musculoskeletal pain, unhealed fractures, contractures, active infections or major cardiovascular diseases among other exclusions.Inclusion Criteria
I have had a spinal cord injury for at least 2 years.
Participant Groups
The study tests how well electrical stimulation of the spine combined with breathing exercises can help control breathing in people with chronic spinal cord injuries. It aims to find specific stimulation settings that improve neural responses and promote recovery of respiratory functions.
3Treatment groups
Experimental Treatment
Active Control
Group I: Spinal Cord Stimulation and Respiratory TrainingExperimental Treatment2 Interventions
Research subjects with implanted stimulator undergoing stimulation intervention in combination with respiratory training.
Group II: Spinal Cord StimulationActive Control1 Intervention
Research subjects with implanted stimulator undergoing stimulation intervention.
Group III: Respiratory TrainingActive Control1 Intervention
Research subjects with no implanted stimulator undergoing RT intervention.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Frazier Rehabilitation and Neuroscience InstituteLouisville, KY
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Who is running the clinical trial?
University of LouisvilleLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Electrical activation of the expiratory muscles to restore cough. [2007]Many patients with spinal cord injury have paralysis of their expiratory muscles and, consequently, lack an effective cough. The purpose of the present study was to evaluate the utility of lower thoracic spinal cord stimulation (SCS) to activate the expiratory muscles. Studies were performed on 15 anesthetized dogs. A quadripolar stimulating electrode (Medtronic Model 3586) was inserted epidurally and on the ventral surface of the lower thoracic spinal cord. Changes in airway pressure, airflow, and internal intercostal and abdominal muscle length were monitored to assess the effects of electrical stimulation. Spinal stimulation applied at the T9-T10 spinal level provided maximal changes in airway pressure generation in preliminary experiments. All subsequent studies were therefore performed with the electrode positioned at this level. The expiratory muscles were stimulated supramaximally over a wide range of lung volumes which were expressed as the corresponding change in airway pressure. The pressure-generating capacity of the expiratory muscles was evaluated by the change in airway pressure produced by SCS during airway occlusion. Peak expiratory airflow was also monitored following release of occlusion. At FRC, deflation (-10 cm H2O) and inflation (+ 30 cm H2O), SCS resulted in positive airway pressures of 44 cm H2O +/- 4 SE, 28 cm H2O +/- 3 SE, and 82 cm H2O +/- 7 SE. The relationship between airway pressure expiratory airflow generation and lung volume was linear (slope = 1.34 +/- 0.04) over the entire vital capacity range. Our results indicate that: (1) a major portion of the expiratory muscles can be activated reproducibly and in concert by electrical stimulation, and (2) this technique may be a clinically useful method of restoring cough in spinal cord injured patients.
Respiratory muscle strength training: functional outcomes versus plasticity. [2022]Respiratory muscle strength training is a paradigm that has been used for numerous years with a variety of populations including but not limited to spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, Parkinson's disease, voice disordered, sedentary elderly, and healthy young. The respiratory muscle strength program discussed here is an expiratory muscle strength training and uses a pressure threshold device with a regimented treatment protocol. The primary purpose of the expiratory muscle strength training program is to promote strength in the expiratory muscles. The training protocol occurs five times per day, 5 days a week, and consists of ~15-20 minutes per day of training by the user at home. The device threshold is changed weekly by a clinician to maintain a threshold load of 75% of an individual's maximum expiratory pressure. The threshold setting of the device is always based on the individual's recorded maximum expiratory pressure generated into a digital pressure gauge. Results of 4 weeks of expiratory muscle strength training protocols indicate up to a 50% improvement for healthy subjects, those with multiple sclerosis, and those with spinal cord injury. The potential transfer of expiratory muscle strength to functional outcomes is discussed, as well as how strength-training paradigms may influence cortical plasticity.
Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. [2021]Evaluation of the capacity of lower thoracic spinal cord stimulation (SCS) to activate the expiratory muscles and generate large airway pressures and high peak airflows characteristic of cough, in subjects with tetraplegia.
Resistive inspiratory muscle training in people with spinal cord injury during inpatient rehabilitation: a randomized controlled trial. [2014]People with spinal cord injury (SCI) may benefit from resistive inspiratory muscle training (RIMT). Current evidence is weak, and little is known about the effect on functional outcomes and long-term effects.
Inspiratory muscle training is feasible and safe for patients with acute spinal cord injury. [2020]To investigate the feasibility and safety and, to a lesser extent efficacy, of inspiratory muscle training (IMT) for patients with acute complete cervical or thoracic spinal cord injury (SCI).
Community exercise for individuals with spinal cord injury with inspiratory muscle training: A pilot study. [2022]Context/Objective: Respiratory disorders are a common cause of rehospitalization, and premature death in individuals with spinal cord injuries (SCI). Respiratory training combined with community exercise programs may be a method to reduce secondary complications in this population.Objective: The present study explores the inclusion of inspiratory muscle training (IMT) in an existing community exercise program.Design: Case series.Setting: Community.Participants: Participants (N = 6) completed the exercise program. Five were male and one was female; four reported incomplete injuries, and two reported complete injuries; four had cervical injuries, and two had thoracic injuries. The average age was 33 years (SD = 18.6) and time since injury was 7 years (SD = 4.0).Interventions: Participants completed an 8-week program, once-per-week for 4 h that included a circuit of resistance training, aerobic exercise, trunk stability, and education. IMT was completed as a home exercise program.Outcome Measures: Transfer test, T-shirt test, four-directional reach, four-directional trunk strength, weekly training diaries, and a subjective interview.Results: Twenty-eight training logs were collected. All measures improved: transfer test (mean = -14.62, SD = 7.00 s), T-shirt test (mean = -7.83, SD = 13.88 s), four-directional reach (mean = 3.75, SD = 8.06 in) and hand-held dynamometer (mean = 6.73, SD = 8.02 kg). Individuals reported a positive impact of the program.Conclusions: This pilot study demonstrated community exercise with IMT use may have positive impact on functional measures for people with SCI who are vulnerable to respiratory compromise. Continued education may increase successful health outcomes.Trial Registration: NCT03743077.
Closed-Loop, Cervical, Epidural Stimulation Elicits Respiratory Neuroplasticity after Spinal Cord Injury in Freely Behaving Rats. [2023]Over half of all spinal cord injuries (SCIs) are cervical, which can lead to paralysis and respiratory compromise, causing significant morbidity and mortality. Effective treatments to restore breathing after severe upper cervical injury are lacking; thus, it is imperative to develop therapies to address this. Epidural stimulation has successfully restored motor function after SCI for stepping, standing, reaching, grasping, and postural control. We hypothesized that closed-loop stimulation triggered via healthy hemidiaphragm EMG activity has the potential to elicit functional neuroplasticity in spinal respiratory pathways after cervical SCI (cSCI). To test this, we delivered closed-loop, electrical, epidural stimulation (CLES) at the level of the phrenic motor nucleus (C4) for 3 d after C2 hemisection (C2HS) in freely behaving rats. A 2 × 2 Latin Square experimental design incorporated two treatments, C2HS injury and CLES therapy resulting in four groups of adult, female Sprague Dawley rats: C2HS + CLES (n = 8), C2HS (n = 6), intact + CLES (n = 6), intact (n = 6). In stimulated groups, CLES was delivered for 12-20 h/d for 3 d. After C2HS, 3 d of CLES robustly facilitated the slope of stimulus-response curves of ipsilesional spinal motor evoked potentials (sMEPs) versus nonstimulated controls. To our knowledge, this is the first demonstration of CLES eliciting respiratory neuroplasticity after C2HS in freely behaving animals. These findings suggest CLES as a promising future therapy to address respiratory deficiency associated with cSCI.
Transcutaneous Spinal Cord Stimulation Improves Respiratory Muscle Strength and Function in Subjects with Cervical Spinal Cord Injury: Original Research. [2023](1) Background: Respiratory muscle weakness is common following cervical spinal cord injury (cSCI). Transcutaneous spinal cord stimulation (tSCS) promotes the motor recovery of the upper and lower limbs. tSCS improved breathing and coughing abilities in one subject with tetraplegia. Objective: We therefore hypothesized that tSCS applied at the cervical and thoracic levels could improve respiratory function in cSCI subjects; (2) Methods: This study was a randomized controlled trial. Eleven cSCI subjects received inspiratory muscle training (IMT) alone. Eleven cSCI subjects received tSCS combined with IMT (six of these subjects underwent IMT alone first and then they were given the opportunity to receive tSCS + IMT). The subjects evaluated their sensation of breathlessness/dyspnea and hypophonia compared to pre-SCI using a numerical rating scale. The thoracic muscle strength was assessed by maximum inspiratory (MIP), expiratory pressure (MEP), and spirometric measures. All assessments were conducted at baseline and after the last session. tSCS was applied at C3-4 and Th9-10 at a frequency of 30 Hz for 30 min on 5 consecutive days; (3) Results: Following tSCS + IMT, the subjects reported a significant improvement in breathlessness/dyspnea and hypophonia (p < 0.05). There was also a significant improvement in MIP, MEP, and forced vital capacity (p < 0.05). Following IMT alone, there were no significant changes in any measurement; (4) Conclusions: Current evidence supports the potential of tSCS as an adjunctive therapy to accelerate and enhance the rehabilitation process for respiratory impairments following SCI. However, further research is needed to validate these results and establish the long-term benefits of tSCS in this population.
Closed-loop cervical epidural stimulation partially restores ipsilesional diaphragm EMG after acute C2 hemisection. [2023]Cervical spinal cord injury creates lasting respiratory deficits which can require mechanical ventilation long-term. We have shown that closed-loop epidural stimulation (CL-ES) elicits respiratory plasticity in the form of increased phrenic network excitability (Malone et. al., E Neuro, Vol 9, 0426-21.2021, 2022); however, the ability of this treatment to create functional benefits for breathing function per se after injury has not been demonstrated. Here, we demonstrate in C2 hemisected anesthetized rats, a 20-minute bout of CL-ES administered at current amplitudes below the motor threshold restores paralyzed hemidiaphragm activity in-phase with breathing while potentiating contralesional activity. While this acute bout of stimulation did not elicit the increased network excitability seen in our chronic model, a subset of stimulated animals continued spontaneous ipsilesional diaphragm activity for several seconds after stopping stimulation. These results support the use of CL-ES as a therapeutic to rescue breathing after high cervical spinal cord injury, with the potential to lead to lasting recovery and device independence.