Epidural Stimulation + Resistance Training for Spinal Cord Injury
(REST-SCI Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByAshraf S Gorgey, PhD
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: United States Department of Defense
Must not be taking: Anticoagulants, Antiplatelets
Disqualifiers: Neurological injury, Unhealed fracture, Severe scoliosis, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests a new treatment for people with severe spinal cord injuries. It combines electrical stimulation, a robotic walking suit, and muscle-strengthening exercises to help them walk and improve muscle strength. Recent advancements have combined electrical stimulation with robotic exoskeletons to facilitate movement and improve motor recovery in individuals with spinal cord injuries. The goal is to make it easier for these individuals to move and improve their overall health.
Will I have to stop taking my current medications?
The trial requires participants to stop taking anti-coagulants or anti-platelet agents, including aspirin, unless they cannot do so for medical reasons.
What data supports the effectiveness of the treatment Epidural Stimulation + Resistance Training for Spinal Cord Injury?
Research shows that epidural electrical stimulation (EES) can help improve motor function and enable voluntary control of muscle activity in people with spinal cord injuries. Additionally, combining EES with exoskeletal-assisted walking has shown potential in enhancing motor control and enabling unassisted steps in individuals with spinal cord injuries.
12345Is epidural electrical stimulation safe for humans?
Epidural electrical stimulation has been studied for spinal cord injury and is generally considered safe, with safety being monitored through the incidence of adverse events in clinical trials.
12367How does the treatment of Epidural Stimulation + Resistance Training for Spinal Cord Injury differ from other treatments?
This treatment is unique because it combines epidural electrical stimulation (EES) with resistance training to help restore movement and standing ability in people with spinal cord injuries. EES works by stimulating the spinal cord to activate muscle movements, even in those with severe paralysis, and when combined with resistance training, it can enhance motor control and muscle strength.
23456Eligibility Criteria
This trial is for adults aged 18-60 with traumatic motor complete spinal cord injury (SCI) at T10 level or above. They must have intact neural circuitry below the SCI as confirmed by tests, and fit specific criteria like having certain muscle responses. People with severe bone density loss, unhealed fractures, major cardiovascular issues, untreated severe spasticity or pressure sores, among other exclusions, cannot participate.Inclusion Criteria
I am 18-60 years old with a spinal cord injury above T10, confirmed by tests.
My leg muscles respond to electrical stimulation after my spinal cord injury.
I have a spinal injury classified as AIS A or B with motor issues below the injury.
My spinal cord injury is severe, above T10, and confirmed by tests.
I am between 18 and 60 years old.
I have a spinal injury classified as AIS A or B, showing motor deficit below the injury level.
Exclusion Criteria
I have a severe pressure ulcer.
I have high blood pressure that isn't managed or severe dizziness when standing up.
I do not have severe scoliosis or joint issues that prevent me from using an exoskeleton.
I have a fracture in my arm or leg that hasn't healed.
I do not have severe heart disease, unmanaged diabetes, high blood pressure, major skin sores, or a serious urinary infection.
I have a neurological injury that affects my limbs or lower back, not caused by spinal cord injury.
Participant Groups
The study is testing whether using an 'ES Robot Suit' combined with resistance training can improve movement control in people who are paralyzed due to SCI. It compares those who use the suit with epidural stimulation alone to those who also do resistance training for better muscle quality and overall health.
2Treatment groups
Experimental Treatment
Group I: EAW+ES+RTExperimental Treatment3 Interventions
The exoskeletal assisted walking with epidural simulation and resistance training (EAW+ES+RT) group will undergo 6 months of supervised EAW +ES (3X per week) followed by additional 6 months of EAW+ES (3X per week) and progressive RT twice weekly (2X per week). In the EAW+ES+RT group, RT will be administered for 12 weeks using an open kinematic chain approach of applying surface NMES and ankle weights followed by 12 weeks twice weekly of gradually using the implanted ES to perform sit-to-stand approach (i.e. using their body weights to load the exercising muscles in a closed kinematic fashion).
Group II: EAW+ delayed-ES +no-RTExperimental Treatment3 Interventions
The control exoskeletal assisted walking with delayed epidural simulation and without resistance training (EAW+ delayed-ES +no-RT) group will enroll in 6 months of EAW without ES (3X per week) and then this will be followed by additional 6 months (3x per week) of EAW+ES (i.e., delayed entry approach) without conducting RT and will perform either passive movement of passive stretching (2X per week).
Epidural Stimulation is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Epidural Stimulation for:
- Spinal cord injury rehabilitation
- Motor function recovery
- Autonomic function recovery
🇨🇦 Approved in Canada as Epidural Stimulation for:
- Spinal cord injury rehabilitation
- Motor function recovery
- Autonomic function recovery
🇪🇺 Approved in European Union as Epidural Stimulation for:
- Spinal cord injury rehabilitation
- Motor function recovery
- Autonomic function recovery
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Hunter Holmes McGuire VA Medical CenterRichmond, VA
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Who is running the clinical trial?
United States Department of DefenseLead Sponsor
Central Virginia VA Health Care SystemCollaborator
References
Hypertrophy of paravertebral muscles after epidural electrical stimulation shifted: A case report. [2022]Epidural electrical stimulation (EES) has been used to improve motor function in patients with chronic spinal cord injury (SCI). The effect of EES on paravertebral muscles in patients with SCI has been unnoticed. We reported a case of paravertebral muscles hypertrophy after the electrode shifted in a patient with spinal cord injury. We also discussed possible mechanistic accounts for this occurs.
The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. [2021]Spinal cord epidural stimulation (SCES) exhibits a rehabilitation potential of restoring locomotion in individuals with spinal cord injury (SCI). However, this is linked to an intensive rehabilitation locomotion approach, which is impractical to apply among a large clinical SCI population. We, hereby, propose a rehabilitation approach of using SCES to enhance motor control during exoskeletal-assisted walking (EAW). After 24 sessions (12 weeks) of EAW swing assistance decreased from 100% to 35% in a person with C7 complete SCI. This was accompanied by 573 unassisted steps (50% of the total number of steps). Electromyographic pattern improved during EAW, reflecting the subject's ability to rhythmically activate paralyzed muscles. Rate perceived exertion increased during EAW with SCES compared to stepping without SCES. These preliminary findings suggest that using SCES with EAW may be a feasible rehabilitation approach for persons with SCI.
Neuromodulation of evoked muscle potentials induced by epidural spinal-cord stimulation in paralyzed individuals. [2021]Epidural stimulation (ES) of the lumbosacral spinal cord has been used to facilitate standing and voluntary movement after clinically motor-complete spinal-cord injury. It seems of importance to examine how the epidurally evoked potentials are modulated in the spinal circuitry and projected to various motor pools. We hypothesized that chronically implanted electrode arrays over the lumbosacral spinal cord can be used to assess functionally spinal circuitry linked to specific motor pools. The purpose of this study was to investigate the functional and topographic organization of compound evoked potentials induced by the stimulation. Three individuals with complete motor paralysis of the lower limbs participated in the study. The evoked potentials to epidural spinal stimulation were investigated after surgery in a supine position and in one participant, during both supine and standing, with body weight load of 60%. The stimulation was delivered with intensity from 0.5 to 10 V at a frequency of 2 Hz. Recruitment curves of evoked potentials in knee and ankle muscles were collected at three localized and two wide-field stimulation configurations. Epidural electrical stimulation of rostral and caudal areas of lumbar spinal cord resulted in a selective topographical recruitment of proximal and distal leg muscles, as revealed by both magnitude and thresholds of the evoked potentials. ES activated both afferent and efferent pathways. The components of neural pathways that can mediate motor-evoked potentials were highly dependent on the stimulation parameters and sensory conditions, suggesting a weight-bearing-induced reorganization of the spinal circuitries.
Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. [2017]We report a case of chronic traumatic paraplegia in which epidural electrical stimulation (EES) of the lumbosacral spinal cord enabled (1) volitional control of task-specific muscle activity, (2) volitional control of rhythmic muscle activity to produce steplike movements while side-lying, (3) independent standing, and (4) while in a vertical position with body weight partially supported, voluntary control of steplike movements and rhythmic muscle activity. This is the first time that the application of EES enabled all of these tasks in the same patient within the first 2 weeks (8 stimulation sessions total) of EES therapy.
Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. [2022]Although epidural stimulation is a technique that has been used for a number of years to treat individuals with a spinal cord injury, the intended outcome has been to suppress plasticity and pain. Over the last decade considerable progress has been made in realizing the potential of epidural stimulation to facilitate posture and locomotion in subjects with severe spinal cord injury who lack the ability to stand or to step. This progress has resulted primarily from experiments with mice, rats and cats having a complete spinal cord transection at a mid-thoracic level and in humans with a complete spinal cord injury. This review describes some of these experiments performed after the complete elimination of supraspinal input that demonstrates that the circuitry necessary to control remarkably normal locomotion appears to reside within the lumbosacral region of the spinal cord. These experiments, however, also demonstrate the essential role of processing proprioceptive information associated with weight-bearing stepping or standing by the spinal circuitry. For example, relatively simple tonic signals provided to the dorsum of the spinal cord epidurally can result in complex and highly adaptive locomotor patterns. Experiments emphasizing a significant complementary effect of epidural stimulation when combined with pharmacological facilitation, e.g., serotonergic agonists, and/or chronic step training also are described. Finally, a major point emphasized in this review is the striking similarity of the lumbosacral circuitry controlling locomotion in the rat and in the human.
Epidural electrical stimulation to facilitate locomotor recovery after spinal cord injury. [2022]Tonic or phasic electrical epidural stimulation of the lumbosacral region of the spinal cord facilitates locomotion and standing in a variety of preclinical models with severe spinal cord injury. However, the mechanisms of epidural electrical stimulation that facilitate sensorimotor functions remain largely unknown. This review aims to address how epidural electrical stimulation interacts with spinal sensorimotor circuits and discusses the limitations that currently restrict the clinical implementation of this promising therapeutic approach.
Safety and effectiveness of electromyography-induced rehabilitation treatment after epidural electrical stimulation for spinal cord injury: study protocol for a prospective, randomized, controlled trial. [2022]Epidural electrical stimulation is a new treatment method for spinal cord injury (SCI). Its efficacy and safety have previously been reported. Rehabilitation treatment after epidural electrical stimulation is important to ensure and improve the postoperative efficacy of epidural electrical stimulation in patients with SCI. Considering that electromyography (EMG)-induced rehabilitation treatment can accurately match the muscle contraction of patients with SCI, we designed a study protocol for a prospective, randomized controlled trial. In this trial, on the premise of adjusting the spinal cord electrical stimulator to obtain the maximum EMG signal of the target muscle, patients with SCI receiving epidural electrical stimulation will undergo EMG-induced rehabilitation treatment. Recovery of muscle strength of key muscles, quality of life, safety and therapeutic effects will be monitored. Twenty patients with SCI who are scheduled to undergo epidural electrical stimulation in Shanghai Ruijin Rehabilitation Hospital will be randomly divided into two groups with 10 patients per group. The control group will receive conventional rehabilitation treatment. The EMG-induced rehabilitation group will receive EMG-induced rehabilitation treatment of the target muscles of the upper and lower limbs based on conventional rehabilitation treatment. After rehabilitation treatment, follow up for all patients will occur at 2 weeks and 1, 3 and 6 months. The primary outcome measure of this trial will be evaluation of target muscle recovery using the Manual Muscle Testing grading scale. Secondary outcome measures will include modified Barthel Index scores, integrated EMG values, the visual analogue scale, Spinal Cord Independence Measure scores, and modified Ashworth scale scores. The safety indicator will be the incidence of adverse events. This trial will collect data regarding the therapeutic effects of EMG-induced rehabilitation in patients with SCI receiving epidural electrical stimulation for 6 months after rehabilitation treatment. Findings from this trial will help develop rehabilitation methods in patients with SCI after epidural electrical stimulation. This study protocol was approved by Ethics Committee of Shanghai Ruijin Rehabilitation Hospital (Approval No. RKIRB2022-12) on February 15, 2022 and was registered with Chinese Clinical Trial Registry (registration number: ChiCTR2200061674; date: June 30, 2022). Study protocol version: 1.0.