Optimizing Transcutaneous Spinal Stimulation: Excitability of Evoked Spinal Reflexes is Dependent on Electrode Montage.

Background: There is growing interest in use of transcutaneous spinal stimulation (TSS) for people with neurologic conditions both to augment volitional control (by facilitating motoneuron excitability), and to decrease spasticity (by activating inhibitory networks). Various electrode montages are used during TSS, with little understanding of how electrode position influences spinal circuit activation. We sought to identify the thoracolumbar electrode montage associated with the most robust activation of spinal circuits by comparing posterior root-muscle reflexes (PRM reflexes) elicited by 6 montages. Additionally, we assessed tolerability of the stimulation during PRM reflex testing. Methods: Fifteen adults with intact neurological systems participated in this randomized crossover study. PRM reflexes were evoked transcutaneously using electrode montages with dorsal-ventral (DV) or dorsal-midline (DM) current flow. DV montages included: [1] cathode over T11/T12, anodes over iliac crests (DV-I), [2] cathode over T11/T12, anodes over umbilicus (DV-U), [3] dual paraspinal cathodes at T11/12, anodes over iliac crests (DV-PI), and [4] dual paraspinal cathodes at T11/12, anodes over umbilicus (DV-PU). DM montages included: [5] cathode over T11/12, anode 5cm caudal (DM-C), and [6] cathode over T11/12, anode 5cm rostral (DM-R). PRM reflex recruitment curves were obtained in the soleus muscle of both lower extremities. Results: DV-U and DV-I montages elicited bilateral reflexes with lower reflex thresholds and larger recruitment curve area than other montages. There were no differences in response amplitude at 120% of RT(1.2xRT) or tolerability among montages. Conclusions: Differences in spinal circuit recruitment are reflected in the response amplitude of the PRM reflexes. DV-I and DV-U montages were associated with lower reflex thresholds, indicating that motor responses can be evoked with lower stimulation intensity. DV-I and DV-U montages therefore have the potential for lower and more tolerable interventional stimulation intensities. Our findings optimize electrode placement for interventional TSS and PRM reflex assessments.

Non-invasive Transcutaneous Spinal Cord Stimulation Programming Recommendations for the Treatment of Upper Extremity Impairment in Tetraplegia.

OBJECTIVES: This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS) to effectively improve upper extremity function after chronic spinal cord injury (SCI). It proposes a framework to guide stimulation programming decisions for the successful translation of these techniques into the clinic. MATERIALS AND METHODS: Programming data from 60 participants who completed the Up-LIFT trial and from 17 participants who subsequently completed the LIFT Home trial were analyzed. All observations of stimulation amplitudes, frequencies, waveforms, and electrode configurations were examined. The incidence of adverse events and relatedness to stimulation parameters is reported. A comparison of parameter usage across the American Spinal Injury Association Impairment Scale (AIS) subgroups was conducted to evaluate stimulation strategies across participants with varying degrees of sensorimotor preservation. RESULTS: Active (cathodal) electrodes were typically placed between the C3/C4 and C6/C7 spinous processes. Most sessions featured return (anodal) electrodes positioned bilaterally over the anterior superior iliac spine, although clavicular placement was frequently used by 12 participants. Stimulation was delivered with a 10-kHz carrier frequency and typically a 30-Hz burst frequency. Biphasic waveforms were used in 83% of sessions. Average stimulation amplitudes were higher for biphasic waveforms. The AIS B subgroup required significantly higher amplitudes than did the AIS C and D subgroups. Device-related adverse events were infrequent, and not correlated with specific waveforms or amplitudes. Within the home setting, participants maintained their current amplitudes within 1% of the preset values. The suggested stimulation programming framework dictates the following hierarchical order of parameter adjustments: current amplitude, waveform type, active/return electrode positioning, and burst frequency, guided by clinical observations as required. CONCLUSIONS: This analysis summarizes effective stimulation parameters from the trials and provides a decision-making framework for clinical implementation of tSCS for upper extremity functional restoration after SCI. The parameters are aligned with existing literature and proved safe and well tolerated by participants.

Reliability of the International Spinal Cord Injury Physical Therapy-Occupational Therapy Basic Data Set.

In interventional clinical trials for persons with spinal cord injury (SCI), the influence of experimental biological, pharmacological, or device-related interventions must be differentiated from that of physical and occupational therapy interventions, as rehabilitation influences motor-related outcomes. The International Spinal Cord Injury (ISCI) Physical Therapy-Occupational Therapy Basic Data Set (PT-OT BDS) was developed with the intent to track the content and time of rehabilitation interventions that are delivered concurrently with experimental interventions. We assessed the reliability of the PT-OT BDS based on agreement between users. Following an online training session, physical therapists (PTs) and occupational therapists (OTs) from 10 SCI clinical centers across 7 countries participated. At each center, pairs of therapists (a treating therapist and an observing therapist; PT/PT, OT/OT, or PT/OT) used the PT-OT BDS to record the content and time of therapy sessions for 20 patients. Data were analyzed to determine agreement between therapist pairs regarding the content of the therapy session. The influence of therapist characteristics (professional discipline [PT/OT], years of experience working with individuals with SCI), patient characteristics (level [tetraplegia/paraplegia] and severity [complete/incomplete] of injury), setting (inpatient/outpatient), and whether the center was U.S.- versus non-U.S.-based were also analyzed. There was high agreement for five of seven categories and medium agreement for the remaining two categories. For six of the seven intervention categories, there were no significant differences between the treating and the observing therapists in the percentage of instances that a specific category was selected. Characteristics of the therapists, characteristics of the patient, therapy setting, and global location of the center had no meaningful influence on level of agreement between therapist pairs. The BDS is reliable for use across settings, countries, and with patients of various impairment levels. The study also helped identify additional areas where refinement of the syllabus would be of value.

Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.

Cervical spinal cord injury (SCI) leads to permanent impairment of arm and hand functions. Here we conducted a prospective, single-arm, multicenter, open-label, non-significant risk trial that evaluated the safety and efficacy of ARCEX Therapy to improve arm and hand functions in people with chronic SCI. ARCEX Therapy involves the delivery of externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation. The primary endpoints were safety and efficacy as measured by whether the majority of participants exhibited significant improvement in both strength and functional performance in response to ARCEX Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of participants demonstrated improvements greater than the minimally important difference criteria for both strength and functional domains. Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities and self-reported increases in quality of life. These results demonstrate the safety and efficacy of ARCEX Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier: NCT04697472 .

Optimizing assessment of low frequency H-reflex depression in persons with spinal cord injury.

Considering the growing interest in clinical applications of neuromodulation, assessing effects of various modulatory approaches is increasingly important. Monosynaptic spinal reflexes undergo depression following repeated activation, offering a means to quantify neuromodulatory influences. Following spinal cord injury (SCI), changes in reflex modulation are associated with spasticity and impaired motor control. To assess disrupted reflex modulation, low-frequency depression (LFD) of Hoffman (H)-reflex excitability is examined, wherein the amplitudes of conditioned reflexes are compared to an unconditioned control reflex. Alternatively, some studies utilize paired-pulse depression (PPD) in place of the extended LFD train. While both protocols induce similar amounts of H-reflex depression in neurologically intact individuals, this may not be the case for persons with neuropathology. We compared the H-reflex depression elicited by PPD and by trains of 3-10 pulses to an 11-pulse LFD protocol in persons with incomplete SCI. The amount of depression produced by PPD was less than an 11-pulse train (mean difference = 0.137). When compared to the 11-pulse train, the 5-pulse train had a Pearson's correlation coefficient (R) of 0.905 and a coefficient of determination (R2) of 0.818. Therefore, a 5-pulse train for assessing LFD elicits modulation similar to the 11-pulse train and thus we recommend its use in lieu of longer trains.

Brief High-Velocity Motor Skill Training Increases Step Frequency and Improves Length/Frequency Coordination in Slow Walkers With Chronic Motor-Incomplete Spinal Cord Injury.

OBJECTIVE: To quantify spatiotemporal coordination during overground walking among persons with motor-incomplete spinal cord injury (PwMISCI) by calculating the step length (SL)/step frequency (SF) ratio (ie, the Walk Ratio [WR]) and to examine the effects of motor skill training (MST) on the relationship between changes in these parameters and walking speed (WS). DESIGN: Between-day exploratory analysis. SETTING: Research laboratory in a rehabilitation hospital PARTICIPANTS: PwMISCI (N=26). INTERVENTIONS: 3-day high-velocity MST. MAIN OUTCOME MEASURES: Overground WS, SL, SF, and WR measured during the 10-Meter Walk Test. RESULTS: Among the full sample, MST was associated with increases in WS, SL, SF, and a decrease in the WR. Relative change in WS and SF was higher among slow (ΔWS=↑46%, ΔSF=↑28%) vs fast (ΔWS=↑16%, ΔSF=↑8%) walkers. Change in the WR differed between groups (slow: ΔWR=↓10%; fast: ΔWR=0%). Twenty-six percent of the variability observed in ΔWR among slow walkers could be explained by ΔSF, while ΔSL did not contribute to ΔWR. Among fast walkers, ΔSL accounted for more than twice the observed ΔWR (43%) compared to ΔSF (15%). CONCLUSIONS: On the whole, WR values among PwMISCI are higher than previous reports in other neurologic populations; however, values among fast walkers were comparable to noninjured adults. Slow walkers demonstrated greater variability in the WR, with higher values associated with slower WS. Following MST, increases in WS coincided with a decrease in the WR among slow walkers, mediated primarily through an effect on SF. This finding may point to a specific mechanism by which MST facilitates improvements in WS among PwMISCI with greater mobility deficits.

REPORT-SCS: minimum reporting standards for spinal cord stimulation studies in spinal cord injury.

Objective.Electrical spinal cord stimulation (SCS) has emerged as a promising therapy for recovery of motor and autonomic dysfunctions following spinal cord injury (SCI). Despite the rise in studies using SCS for SCI complications, there are no standard guidelines for reporting SCS parameters in research publications, making it challenging to compare, interpret or reproduce reported effects across experimental studies.Approach.To develop guidelines for minimum reporting standards for SCS parameters in pre-clinical and clinical SCI research, we gathered an international panel of expert clinicians and scientists. Using a Delphi approach, we developed guideline items and surveyed the panel on their level of agreement for each item.Main results.There was strong agreement on 26 of the 29 items identified for establishing minimum reporting standards for SCS studies. The guidelines encompass three major SCS categories: hardware, configuration and current parameters, and the intervention.Significance.Standardized reporting of stimulation parameters will ensure that SCS studies can be easily analyzed, replicated, and interpreted by the scientific community, thereby expanding the SCS knowledge base and fostering transparency in reporting.

Mastering Our Own Magic in the Evolution Toward Precision Practice.

Edelle (Edee) Field-Fote, PT, PhD, FASIA, FAPTA, the 54th Mary McMillan lecturer, is director of the Shepherd Center Spinal Cord Injury Research Program & Hulse Laboratory; professor in the division of physical therapy at Emory University School of Medicine; and professor of the practice in the school of biological sciences at the Georgia Institute of Technology. In her role as the director of spinal cord injury (SCI) research at Shepherd Center, Field-Fote leads a team dedicated to improving motor function in people with SCI through the development of neuromodulation and neurorehabilitation approaches informed by the latest neuroscience research and guided by outcomes that have meaning for people with SCI. With a clinical background as a physical therapist, PhD training in a preclinical model of SCI, and postdoctoral training in motor control physiology, her 25-plus years of SCI research have spanned the breadth of basic and clinical/translational research related to SCI. Dr Field-Fote has conducted randomized clinical trials with funding from the National Institutes of Health since 1997; other clinical trials in her lab have been funded by the Department of Defense, the National Institute on Disability Independent Living and Rehabilitation Research, and numerous foundations. Field-Fote is the recipient of multiple honors from the American Physical Therapy Association (APTA) and its components. She is a Fellow of APTA and a Fellow of the American Spinal Injury Association. She has also served in numerous APTA and APTA component appointed or elected positions and as a member and president of the Foundation for Physical Therapy Research Board of Trustees.

Development of an integrated conceptual model of multiple sclerosis spasticity.

PURPOSE: Spasticity is common in multiple sclerosis (MS), often leading to functional limitations and disability. We developed a conceptual model of spasticity in MS integrating expert opinion, recent literature, and experiences of clinicians and people with MS spasticity. METHODS: A conceptual model was developed based on a targeted literature review of articles published between 2014 and 2019, followed by input from clinicians, then input from participants with MS spasticity. Multidisciplinary experts on spasticity provided guidance at each step. RESULTS: Key concepts of the integrated spasticity conceptual model included: moderators; triggers; modifiers; treatment; objective manifestations; subjective experience; physical, functional, social, and emotional/psychological impacts; and long-term consequences. Participants with MS spasticity most frequently endorsed spasms, tightness, and pain as descriptors of spasticity. Some participants with MS spasticity had difficulty distinguishing spasticity from other MS symptoms (e.g. muscle weakness). Some triggers, emotional/psychological impacts, and long-term consequences of spasticity reported by participants with MS spasticity were not previously identified in the published literature. CONCLUSIONS: This conceptual model of spasticity, integrating published literature with the experience of clinicians, people with MS spasticity, and experts, demonstrates the complex, multidimensional nature of MS spasticity. This model may be used to improve clinician-patient dialogue, research, and patient care.

Many people with multiple sclerosis (MS) have spasticity, generally in the lower limbs, but this symptom is complex and multidimensional and therefore difficult to characterize.MS spasticity may be influenced by moderators, triggers, modifiers, and treatment, all of which can affect objective measures and the subjective experience of spasticity.MS spasticity can have physical, functional, social, and emotional/psychological impacts as well as long-term consequences that can affect rehabilitation and ultimately reduce health-related quality of life for people with MS.Given that people with MS may view spasticity differently than their rehabilitation providers, providers should ask patients about their spasticity, including their moderators, triggers, modifiers, experience, impacts, long-term consequences, and effects on quality of life.This conceptual model provides a framework to improve clinician-patient dialogue, research, and rehabilitation for MS spasticity.

Assessment of Dorsiflexion Ability across Tasks in Persons with Subacute SCI after Combined Locomotor Training and Transcutaneous Spinal Stimulation.

In people with spinal cord injury (SCI), transcutaneous spinal stimulation (TSS) has an immediate effect on the ability to dorsiflex the ankle, but persistent effects are not known. Furthermore, TSS has been associated with improved walking, increased volitional muscle activation, and decreased spasticity when combined with locomotor training (LT). In this study, the persistent impact of combined LT and TSS on dorsiflexion during the swing phase of walking and a volitional task in participants with SCI is determined. Ten participants with subacute motor-incomplete SCI received 2 weeks of LT alone (wash-in phase), followed by 2 weeks of either LT + TSS (TSS at 50 Hz) or LT + TSSSham (intervention phase). There was no persistent effect of TSS on dorsiflexion during walking and inconsistent effects on the volitional task. There was a strong positive correlation between the dorsiflexor ability for both tasks. There was a moderate effect of 4 weeks of LT on increased dorsiflexion during the task (d = 0.33) and walking (d = 0.34) and a small effect on spasticity (d = -0.2). Combined LT + TSS did not show persistent effects on dorsiflexion ability in people with SCI. Four weeks of locomotor training was associated with increased dorsiflexion across tasks. Improvements in walking observed with TSS may be due to factors other than improved ankle dorsiflexion.