Trial Summary
What is the purpose of this trial?This trial uses electrical stimulation techniques to help patients with partial spinal cord injuries improve their arm and hand movements. The treatment works by enhancing the timing and coordination of nerve signals, making it easier for the brain and spinal cord to control muscles. Electrical stimulation of the spinal cord has been practiced as a therapy by the medical community for a long time.
Do I need to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking drugs that act on the central nervous system and lower the seizure threshold, like certain antipsychotics or tricyclic antidepressants.
What data supports the idea that Electrical Stimulation for Spinal Cord Injury is an effective treatment?The available research shows that electrical stimulation can help predict and improve outcomes for people with spinal cord injuries. It can be used to assess the severity of the injury and predict recovery in areas like walking ability and hand function. This is especially useful because it can be applied even when patients are unable to cooperate fully. Compared to just clinical exams, these techniques provide more reliable and early predictions, which can guide therapy planning. This makes electrical stimulation a valuable tool in the rehabilitation process for spinal cord injuries.345810
Is electrical stimulation a promising treatment for spinal cord injury?Yes, electrical stimulation is a promising treatment for spinal cord injury. It can help restore motor functions, like walking, in people with paralysis by activating the spinal cord's motor networks. This treatment can also help in understanding and measuring spinal cord activity, which can improve therapy outcomes.237910
What safety data exists for electrical stimulation in spinal cord injury treatment?The safety data for electrical stimulation in spinal cord injury treatment is limited and varies across studies. A systematic review of 64 clinical trials highlighted the use of various electrophysiological outcome measures, such as electromyography and motor evoked potentials, but noted significant heterogeneity in methods and reporting. Another study on rats suggested that electrical stimulation might aid in membrane repair by modulating injury potential. However, comprehensive safety assessments, especially in humans, are still needed.1671011
Eligibility Criteria
This trial is for adults aged 18-85 with chronic spinal cord injury (SCI) at C8 or above, who can still perform certain reach and grasp movements. It's also open to right-handed healthy controls without SCI but with similar abilities. Pregnant women, individuals with metal in the skull, seizure history, severe medical issues, depression/psychosis, head injury/stroke history, pacemakers or those on specific CNS drugs are excluded.Inclusion Criteria
I am between 18-85 years old with a spinal cord injury at C8 or above, and can still move my hands.
I am between 18-85 years old, right-handed, and can reach and grasp objects without leaning forward.
Exclusion Criteria
I have a history of seizures.
I do not have unmanaged lung, heart, or bone problems.
I had a condition before my spinal cord injury that made it hard for me to exercise.
I am taking medication that affects my brain and could make seizures more likely.
I have had a brain tumor or brain infection in the past.
I have a spinal condition like stenosis, spina bifida, or a herniated disk.
I have had a head injury or stroke in the past.
Treatment Details
The study aims to improve motor function in people with SCI using advanced electrophysiological methods to test corticospinal connections. Participants will undergo assessments of muscle response timing and location plus training that includes some form of stimulation focused on enhancing reach and grasp movements.
3Treatment groups
Experimental Treatment
Active Control
Group I: Electrophysiology Assessment of Time DomainExperimental Treatment2 Interventions
Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function
Group II: Electrophysiology Assessment of LocationExperimental Treatment2 Interventions
Assessment of electrophysiology to examine spatial organization of corticospinal function
Group III: Training with some stimulationActive Control1 Intervention
Training with non-invasive stimulation and training with sham stimulation
Find a clinic near you
Research locations nearbySelect from list below to view details:
Shirley Ryan AbilityLabChicago, IL
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Electrophysiological evaluation of the patient with acute spinal cord injury. [2005]This article reviews basic principles, equipment and techniques, and clinical applications of electrophysiologic monitoring in patients with spinal cord injuries. Four groups of electrophysiologic measurements are considered: Somatosensory evoked potentials (SEPs); motor evoked potentials (MEPs); electromyography (EMG) and nerve conduction studies; and late responses, including H reflex, M response, and F wave. Reports of SEP recordings in spinal cord injury, as drawn from the literature, are tabulated in detail.
Spinal cord stimulation as a tool for physiological research. [2019]The use of spinal cord stimulation for alleviation of disabilities due to motor neuron lesions has provided the opportunity to explore a new approach to measurement of spinal cord physiology. Externalized leads of epidural electrodes provide the possibility of recording evoked spinal cord activity, while both externalized or implanted leads can be used to study cortical evoked responses and twitches induced by spinal cord stimulation. The use of such electrophysiological techniques can be expected to expand greatly the applicability of the technique for alleviating motor disabilities, through a better definition of the degree, nature and extent of the lesion.
[Prognosis of traumatic spinal cord lesions. Significance of clinical and electrophysiological findings]. [2019]The clinical examination of patients with spinal cord injury can be supplemented by electrophysiological techniques (somatosensory-evoked potentials (SSEP), motor-evoked potentials (MEP), electroneurography) to assess the extent and severity of a spinal cord injury. As essential advantage of these techniques in comparison with the clinical examination is that they can be reliably applied even in uncooperative patients. These techniques allow an early prognosis of the functional deficit in patients with acute spinal cord injury. Recordings of tibial nerve SSEP and MEP of the anterior tibial muscle allow to predict the outcome of ambulatory capacity, while recordings of pudendal nerve SSEP allow prognosis of the bladder function to be assessed. In tetraplegic patients median and ulnar nerve SSEP and MEP of the abductor digiti minimi muscle can indicate the development of hand function. Electroneurography allows to differentiate between the proportion of peripheral and central nervous lesions underlying the muscle paresis. This is of prognostic value with regard to the development of muscle tone and consequently for planning therapy. The electrophysiological examinations are of complementary value in the diagnostic assessment of spinal cord lesions, in the prediction of functional outcome, and in monitoring the course of neurological deficits. This is helpful for planning and selection of appropriate therapeutic approaches (e.g. functional electrical stimulation, application of botulinum toxin, splinting procedures) within the rehabilitation programme.
[Neurological diagnosis and prognosis: significance of neurophysiological findings in traumatic spinal cord lesions]. [2006]The clinical examination of patients with spinal cord injury can be supplemented by electrophysiological techniques (somatosensory evoked potentials [SSEP], motor evoked potentials [MEP], and electroneuromyographic recordings [ENMG]) to assess the extent and severity of a spinal cord injury. An essential advantage of these techniques in comparison with clinical examination is that they can also be reliably applied in uncooperative patients. These techniques allow early prognosis regarding the functional deficit in patients with acute spinal cord injury. Recordings of tibial nerve somatosensory evoked potentials and motor evoked potentials of the anterior tibial muscle serve to predict the outcome of ambulatory capacity, and pudendal nerve somatosensory evoked potentials that of bladder function. In tetraplegic patients median and ulnar nerve somatosensory evoked potentials and motor evoked potentials of the abductor digiti min. muscle may indicate the outcome of hand function at an early stage. The electroneuromyographic recordings make it possible to differentiate between the proportion of peripheral and central nervous lesion underlying a muscle paresis. This is of prognostic value in regard to the development of muscle tone and consequently for planning of therapy. The electrophysiological examinations are of complementary value in the diagnostic assessment of spinal cord lesions, in the prediction of functional outcome, and in monitoring the course of neurological deficits. This is helpful for planning and selection of appropriate therapeutic approaches within the rehabilitation programme.
Electrophysiological evaluation of root and spinal cord disease. [2005]The electrophysiological evaluation of root or spinal cord disease is complementary to neuroimaging studies, providing information about functional rather than anatomical integrity and information that is important for diagnostic and prognostic purposes. The electrophysiological findings help to localize a lesion but are not pathognomonic of specific diseases. The findings may also provide insight into underlying physiological mechanisms that have been disrupted. A number of different electrophysiological techniques are now in widespread use. Each of these techniques provides different information and thus has distinct utility and limitations. The optimal evaluation of patients with root or spinal cord disease requires an understanding of how these techniques complement each other and depends on the individual clinical problem for which electrophysiological assessment is requested.
Characterization of graded multicenter animal spinal cord injury study contusion spinal cord injury using somatosensory-evoked potentials. [2021]Electrophysiological analysis using somatosensory-evoked potentials (SEPs) and behavioral assessment using Basso, Beattie, Bresnahan (BBB) scale were compared over time for graded Multicenter Animal Spinal Cord Injury Study (MASCIS) contusion spinal cord injury (SCI).
Compensation for injury potential by electrical stimulation after acute spinal cord injury in rat. [2020]Injury potential, a direct current potential difference between normal section and the site of injury, is a significant index of spinal cord injury. However, its importance has been ignored in the studies of spinal cord electrophysiology and electrical stimulation (ES). In this paper, compensation for injury potential is used as a criterion to adjust the intensity of stimulation. Injury potential is modulated to slightly larger than 0 mV for 15, 30 and 45 minutes immediately after injury by placing the anodes at the site of injury and the cathodes at the rostral and caudal section. Injury potentials of all rats were recorded for statistical analysis. Results show that the injury potentials acquired after ES are higher than those measured from rats without stimulation and much lower than the initial amplitude. It is also observed that the stimulating voltage to keep injury potential be 0 remain the same. This phenomenon suggests that repair of membrane might occur during the period of stimulation. It is also suggested that a constant voltage stimulation can be applied to compensate for injury potential.
Upper Limb Recovery in Spinal Cord Injury: Involvement of Central and Peripheral Motor Pathways. [2017]The course of central and peripheral motor recovery after cervical spinal cord injury (SCI) may be investigated by electrophysiological measures. The goal of this study was to compare the 2 over the first year after injury in relation to motor gains.
Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. [2020]Epidural electrical stimulation (EES) of the spinal cord has been shown to restore function after spinal cord injury (SCI). Characterization of EES-evoked motor responses has provided a basic understanding of spinal sensorimotor network activity related to EES-enabled motor activity of the lower extremities. However, the use of EES-evoked motor responses to guide EES system implantation over the spinal cord and their relation to post-operative EES-enabled function in humans with chronic paralysis attributed to SCI has yet to be described. Herein, we describe the surgical and intraoperative electrophysiological approach used, followed by initial EES-enabled results observed in 2 human subjects with motor complete paralysis who were enrolled in a clinical trial investigating the use of EES to enable motor functions after SCI. The 16-contact electrode array was initially positioned under fluoroscopic guidance. Then, EES-evoked motor responses were recorded from select leg muscles and displayed in real time to determine electrode array proximity to spinal cord regions associated with motor activity of the lower extremities. Acceptable array positioning was determined based on achievement of selective proximal or distal leg muscle activity, as well as bilateral muscle activation. Motor response latencies were not significantly different between intraoperative recordings and post-operative recordings, indicating that array positioning remained stable. Additionally, EES enabled intentional control of step-like activity in both subjects within the first 5 days of testing. These results suggest that the use of EES-evoked motor responses may guide intraoperative positioning of epidural electrodes to target spinal cord circuitry to enable motor functions after SCI.
Electrophysiological Outcome Measures in Spinal Cord Injury Clinical Trials: A Systematic Review. [2020]Background: Electrophysiological measures are being increasingly utilized due to their ability to provide objective measurements with minimal bias and to detect subtle changes with quantitative data on neural function. Heterogeneous reporting of trial outcomes limits effective interstudy comparison and optimization of treatment. Objective: The objective of this systematic review is to describe the reporting of electrophysiological outcome measures in spinal cord injury (SCI) clinical trials in order to inform a subsequent consensus study. Methods: A systematic search of PubMed and EMBASE databases was conducted according to PRISMA guidelines. Adult human SCI clinical trials published in English between January 1, 2008 and September 15, 2018 with at least one electrophysiological outcome measure were eligible. Findings were reviewed by all authors to create a synthesis narrative describing each outcome measure. Results: Sixty-four SCI clinical trials were included in this review. Identified electrophysiological outcomes included electromyography activity (44%), motor evoked potentials (33%), somatosensory evoked potentials (33%), H-reflex (20%), reflex electromyography activity (11%), nerve conduction studies (9%), silent period (3%), contact heat evoked potentials (2%), and sympathetic skin response (2%). Heterogeneity was present in regard to both methods of measurement and reporting of electrophysiological outcome measures. Conclusion: This review demonstrates need for the development of a standardized reporting set for electrophysiological outcome measures. Limitations of this review include exclusion of non-English publications, studies more than 10 years old, and an inability to assess methodological quality of primary studies due to a lack of guidelines on reporting of systematic reviews of outcome measures.
The application of electrophysiological methods to characterize AMPA receptors in dissociated adult rat and non-human primate cerebellar neurons for use in neuronal safety pharmacology assessments of the central nervous system. [2021]Pre-clinically, safety risk assessment of a drug is primarily tested in vivo using functional evaluation of adult animals while the mechanistic etiology of drug-induced CNS adverse effects is often uncharacterized. In vitro electrophysiology may provide a better understanding of drug effects without additional animal use. However, in vitro protocols are typically designed for using embryonic or juvenile animals.