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Current barriers and ethical considerations for clinical implementation of epidural stimulation for functional improvement after spinal cord injury.

ABSTRACT: Context/objective: To determine current barriers for clinical implementation of epidural stimulation for functional improvement after spinal cord injury and highlight applicable ethical constructs to approach future research. Design: Survey of spinal cord injury medicine physicians, January 2019. Setting: Spinal cord injury model systems hospital sites across the United States. Participants: Spinal cord injury medicine physicians. Interventions: NA. Outcome measures: Physician-identified current barriers to clinical implementation of epidural stimulation. Results: The response rate for the survey was 54.6% (n = 42), with the majority of physicians (61.9%) having been asked by patients with spinal cord injuries about epidural stimulation. Numerous current barriers to clinical implementation were identified, including need for additional efficacy studies (92.9%), lack of clear guidelines on stimulation parameters (83.3%), and inability to identify which patients will benefit (76.2%). Conclusions: With multiple barriers to clinical implementation currently identified, evaluating this research with an eye toward the ethical construct of equipoise is increasingly relevant. Addressing these barriers may require modifications in both physician expectations and how researchers approach this work.

SUBMITTER: Solinsky R

PROVIDER: S-EPMC7534328 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Previous studies have shown that epidural stimulation of the lumbosacral spinal cord (scES) can re-enable lower limb volitional motor control in individuals with chronic, clinically motor complete spinal cord injury (SCI). This observation entails that residual supraspinal connectivity to the lumbosacral spinal circuitry still persisted after SCI, although it was non-detectable when scES was not provided. In the present study, we aimed at exploring further the mechanisms underlying scES-promoted recovery of volitional lower limb motor control by investigating neuroimaging markers at the spinal cord lesion site via magnetic resonance imaging (MRI). Spinal cord MRI was collected prior to epidural stimulator implantation in 13 individuals with chronic, clinically motor complete SCI, and the spared tissue of specific regions of the spinal cord (anterior, posterior, right, left, and total cord) was assessed. After epidural stimulator implantation, and prior to any training, volitional motor control was evaluated during left and right lower limb flexion and ankle dorsiflexion attempts. The ability to generate force exertion and movement was not correlated to any neuroimaging marker. On the other hand, spared tissue of specific cord regions significantly and importantly correlated with some aspects of motor control that include activation amplitude of antagonist (negative correlation) muscles during left ankle dorsiflexion, and electromyographic coordination patterns during right lower limb flexion. The fact that amount and location of spared spinal cord tissue at the lesion site were not related to the ability to generate volitional lower limb movements may suggest that supraspinal inputs through spared spinal cord regions that differ across individuals can result in the generation of lower limb volitional motor output prior to any training when epidural stimulation is provided.

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Changes in spinal cord hemodynamics reflect modulation of spinal network with different parameters of epidural stimulation.

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