Clinical Outcome Measures Following Peripheral Nerve Repair

Wilcox, Matthew; Brown, Hazel; Quick, Tom

doi:10.1007/978-3-030-06217-0_11-1

Cited by 4 publications

(5 citation statements)

References 175 publications

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“…The development of responsive outcome measures is critical in the context of clinical nerve repair research. Successful clinical translation of novel regenerative therapies will likely depend on the ability of outcome measures to capture small incremental changes over time 31 . Conventional clinical metrics such as MRC grading are not sufficiently sensitive to the biological process of muscle reinnervation and therefore limit the design of clinical trials of therapies which hope to enhance nerve repair [31][32][33] .…”

Section: Discussionmentioning

confidence: 99%

Volumetric MRI is a promising outcome measure of muscle reinnervation

Wilcox

Canas

Hargunani

et al. 2021

Sci Rep

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The development of outcome measures that can track the recovery of reinnervated muscle would benefit the clinical investigation of new therapies which hope to enhance peripheral nerve repair. The primary objective of this study was to assess the validity of volumetric Magnetic Resonance Imaging (MRI) as an outcome measure of muscle reinnervation by testing its reproducibility, responsiveness and relationship with clinical indices of muscular function. Over a 3-year period 25 patients who underwent nerve transfer to reinnervate elbow flexor muscles were assessed using intramuscular electromyography (EMG) and MRI (median post-operative assessment time of 258 days, ranging from 86 days pre-operatively to 1698 days post- operatively). Muscle power (Medical Research Council (MRC) grade) and Stanmore Percentage of Normal Elbow Assessment (SPONEA) assessment was also recorded for all patients. Sub-analysis of peak volitional force (PVF), muscular fatigue and co-contraction was performed in those patients with MRC > 3. The responsiveness of each parameter was compared using Pearson or Spearman correlation. A Hierarchical Gaussian Process (HGP) was implemented to determine the ability of volumetric MRI measurements to predict the recovery of muscular function. Reinnervated muscle volume per unit Body Mass Index (BMI) demonstrated good responsiveness (R2 = 0.73, p < 0.001). Using the temporal and muscle volume per unit BMI data, a HGP model was able to predict MRC grade and SPONEA with a mean absolute error (MAE) of 0.73 and 1.7 respectively. Muscle volume per unit BMI demonstrated moderate to good positive correlations with patient reported impairments of reinnervated muscle; co- contraction (R2 = 0.63, p = 0.02) and muscle fatigue (R2 = 0.64, p = 0.04). In summary, volumetric MRI analysis of reinnervated muscle is highly reproducible, responsive to post-operative time and demonstrates correlation with clinical indices of muscle function. This encourages the view that volumetric MRI is a promising outcome measure for muscle reinnervation which will drive advancements in motor recovery therapy.

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Section: Discussionmentioning

confidence: 99%

Volumetric MRI is a promising outcome measure of muscle reinnervation

Wilcox

Canas

Hargunani

et al. 2021

Sci Rep

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“…Clinical diagnostic tools such as electromyography (EMG) and magnetic resonance imaging (MRI) analysis have emerged as the mainstay investigations to detect and monitor severe nerve injury 13–15 . However, they are expensive to perform and difficult to interpret 15,16 without input from highly trained specialised clinicians. In many cases, it is not possible to delineate between different severities of nerve injury using these tests 5 .…”

Section: Introductionmentioning

confidence: 99%

“…Serum NfL assays are also significantly cheaper, less invasive and easier to interpret than EMG and MRI 18 . Studies which link NfL assays to a volume of axonal injury could form the basis for an improved quantitative classification system of nerve injury severity that has the power to inform clinical management at an earlier stage post‐injury than is currently possible with conventional technologies 15,23 . Data which characterise: (1) the serum NfL signal seen following different severities of nerve trauma and (2) the time course of serum NfL changes after nerve injury will provide essential information that will inform the clinical utility of serum NfL in the context of nerve trauma.…”

Section: Introductionmentioning

confidence: 99%

Serum neurofilament light chain measurements following nerve trauma

Wilcox

Rayner

Guillemot-Legris

et al. 2023

J Peripheral Nervous Sys

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BackgroundOptimal functional recovery following peripheral nerve injuries (PNIs) is dependent upon early recognition and prompt referral to specialist centres for appropriate surgical intervention. Technologies which facilitate the early detection of PNI would allow faster referral rates and encourage improvements in patient outcomes. Serum Neurofilament light chain (NfL) measurements are cheaper to perform, easier to access and interpret than many conventional methods used for nerve injury diagnosis, such as electromyography and/or magnetic resonance imaging assessments, but changes in serum NfL levels following traumatic PNI have not been investigated. This pre‐clinical study aimed to determine whether serum NfL levels can: (1) detect the presence of a nerve trauma and (2) delineate between different severities of nerve trauma.MethodsA rat sciatic nerve crush and common peroneal nerve crush were implemented as controlled animal models of nerve injury. At 1‐, 3‐, 7‐ and 21‐days post‐injury, serum samples were retrieved for analysis using the SIMOA® NfL analyser kit. Nerve samples were also retrieved for histological analysis. Static sciatic index (SSI) was measured at regular time intervals following injury.ResultsSignificant 45‐fold and 20‐fold increases in NfL serum levels were seen 1‐day post‐injury following sciatic and common peroneal nerve injury, respectively. This corresponded with an eightfold higher volume of axons injured in the sciatic compared to the common peroneal nerve (p < .001). SSI measurements post‐injury revealed greater reduction in function in the sciatic crush group compared with the common peroneal crush group.ConclusionsNfL serum measurements represent a promising method for detecting traumatic PNI and stratifying their severity. Clinical translation of these findings could provide a powerful tool to improve the surgical management of nerve‐injured patients.

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“…Measuring efficacy has traditionally been a problematic issue because nerve injuries are diverse in nature, rarely exist in isolation, and measurable outcomes are often slow and subjective. Recent advances have improved clinical trial approaches for peripheral nerve interventions, providing opportunities to evaluate EngNT and other new therapies in a robust objective manner over an acceptable time frame [12,[41][42][43][44]. Consequently, opportunities exist for early clinical evaluation of EngNT to be conducted in patients with digital nerve injuries, or at the donor site in patients undergoing autografting.…”

Section: Commercialisation and Clinical Translationmentioning

confidence: 99%

‘EngNT’ — Engineering live neural tissue for nerve replacement

Phillips

2021

Emerging Topics in Life Sciences

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Peripheral nerve injury can result in severe long-term disability and current clinical approaches for repairing large gaps rely on the nerve autograft. Engineered Neural Tissue (EngNT) has been developed to provide living aligned therapeutic cells in a stabilised collagen hydrogel, mimicking the key features of the autograft. This Perspective article will introduce the field and discuss the current stage of translation, highlighting the key opportunities for commercial and clinical development.

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Clinical Outcome Measures Following Peripheral Nerve Repair

Cited by 4 publications

References 175 publications

Volumetric MRI is a promising outcome measure of muscle reinnervation

Volumetric MRI is a promising outcome measure of muscle reinnervation

Serum neurofilament light chain measurements following nerve trauma

‘EngNT’ — Engineering live neural tissue for nerve replacement

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