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Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic cervical spinal cord injury.

ABSTRACT: Study design:A cross-sectional stated-preference survey using direct-assessment questions. Objective:To determine the relative value placed on different outcomes to be used in a pivotal trial for the upper extremity configuration of the Networked Neuroprosthesis (NNP) as well as the tolerance of the expected adverse event profile. Setting:Academic medical center in the United States. Methods:Distribution of an online survey to adults living with tetraplegia; extent of agreement with each question/statement was obtaining using a 1-7 Likert scale. Results:There were 8 statements about potential benefits in arm/hand function; for all statements, more than 70% of participants rated the functions as "1-very important" to regain. There were variable degrees of concern related to risks that could occur during the 30-day post-surgical period and increasing degrees of concern related to risks that could occur in the first 5 years, potentially due to the device, based on the increasing degree of invasiveness of the intervention required to address the event. When analysing the results based on all degrees of interest, more than 64% of responders were interested in getting the NNP with a success rate threshold as low as 50% regardless of time post-injury. Chi-squared analyses revealed some associations between responses and sex, injury level, and injury duration; however, none of these were statistically significant upon post-hoc analysis. Conclusion:Data here indicate that people with tetraplegia are highly interested in a range of arm/hand functions and are tolerant of expected risks that may be associated with implanted neuroprosthetics. Sponsorship:The Institute for Functional Restoration funded this project through a sub-contract to K.D. Anderson from a larger Special Projects Award (grant number FP0020773) from the Craig H. Neilsen Foundation.

SUBMITTER: Anderson KD

PROVIDER: S-EPMC6786403 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic cervical spinal cord injury.

Anderson Kim D KD Bryden Anne M AM Moynahan Megan M

Spinal cord series and cases 20190724

<h4>Study design</h4>A cross-sectional stated-preference survey using direct-assessment questions.<h4>Objective</h4>To determine the relative value placed on different outcomes to be used in a pivotal trial for the upper extremity configuration of the Networked Neuroprosthesis (NNP) as well as the tolerance of the expected adverse event profile.<h4>Setting</h4>Academic medical center in the United States.<h4>Methods</h4>Distribution of an online survey to adults living with tetraplegia; extent o ...[more]

PMID: 31632726

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Project description:Dermatomal maps are a mainstay of clinical practice and provide information on the spatial distribution of the cutaneous innervation of spinal nerves. Dermatomal deficits can help isolate the level of spinal nerve root involvement in spinal conditions and guide clinicians in diagnosis and treatment. Dermatomal maps, however, have limitations, and the spatial distribution of spinal cord sensory activity in humans remains to be quantitatively assessed. Here we used spinal cord functional MRI to map and quantitatively compare the spatial distribution of sensory spinal cord activity during tactile stimulation of the left and right lateral shoulders (i.e. C5 dermatome) and dorsal third digits of the hands (i.e., C7 dermatome) in healthy humans (n = 24, age = 36.8 ± 11.8 years). Based on the central sites for processing of innocuous tactile sensory information, we hypothesized that the activity would be localized more to the ipsilateral dorsal spinal cord with the lateral shoulder stimulation activity being localized more superiorly than the dorsal third digit. The findings demonstrate lateralization of the activity with the left- and right-sided stimuli having more activation in the ipsilateral hemicord. Contradictory to our hypotheses, the activity for both stimulation sites was spread across the dorsal and ventral hemicords and did not demonstrate a clear superior-inferior localization. Instead, the activity for both stimuli had a broader than expected distribution, extending across the C5, C6, and C7 spinal cord segments. We highlight the complexity of the human spinal cord neuroanatomy and several sources of variability that may explain the observed patterns of activity. While the findings were not completely consistent with our a priori hypotheses, this study provides a foundation for continued work and is an important step towards developing normative quantitative spinal cord measures of sensory function, which may become useful objective MRI-based biomarkers of neurological injury and improve the management of spinal disorders.

Dataset Information

Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic cervical spinal cord injury.

Publications

Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic cervical spinal cord injury.

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