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Laryngeal reinnervation: feasibility studies and development of trial outcome measures

Mat Baki, M; (2014) Laryngeal reinnervation: feasibility studies and development of trial outcome measures. Doctoral thesis , UCL (University College London). Green open access

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Abstract

The unifying theme of this thesis is a series of research studies that collectively amount to a feasibility study for clinical trials of laryngeal reinnervation for the treatment of vocal fold paralysis. The question ‘Does laryngeal reinnervation or thyroplasty give better voice results for patients with unilateral vocal fold paralysis (UVFP)?’ remains outstanding; a question that ideally requires a randomised control trial. However, randomised control trials in surgery face inherent surgeons’ equipoise and recruitment issues that may lead to its failure. I performed a national survey of UK ENT consultants exploring their perception and obtaining crude numbers of eligible UVFP patients under their care for such trial, which revealed that the majority of ENT surgeons are receptive to the trial and the size of the potential patient pool is promising. I interviewed eligible UVFP patients to explore issues around the recruitment process, and this suggested that the proposed trial is feasible. Some phraseology used during recruitment that needed changing was identified, which may optimise the recruitment process for a trial. In voice surgery trials, outcome measures should be multidimensional and standardised. Acoustic analysis has been proposed but has limitations. OperaVOX is a potential new acoustic analysis software developed to resolve some of these factors. I demonstrated that OperaVOX is statistically comparable to the ‘gold standard’, Multidimensional Voice Programme, for most principal phonatory outcome measures. Another outcome measure- video-laryngostroboscopy, allows visual evaluation of characteristics and vibratory pattern of vocal folds. It is typically subjective that requires inter- and intra-rater reliability study. Here, I demonstrated that certain parameters depicted substantial inter- and intra-rater reliability. However, I showed that rater training is required to improve the reliability of other parameters. I investigated MRI as a potential non-invasive method to evaluate vocal muscles’ denervation and reinnervation. I found that signal changes on the T2-weighted MRI larynx images correlated with electrophysiological results with good repeatability. Another MRI sequence, dynamic contrast enhanced- and diffusion weighted MRI, suggested reduced perfusion in paralysed muscles, whilst cine-MRI for vocal fold mobility assessment demonstrated considerable potential as a method to grade vocal fold mobility. Finally, I present a small prospective case series of non-selective and selective laryngeal reinnervation in UVFP and unilateral vagal paralysis following vagal tumour excision respectively concomitant with injection laryngoplasty. Voice improvement was demonstrated by voice handicap index-10 and other multidimensional outcome measures, and these were supported by laryngeal electromyography and T2-weighted MRI outcomes. To my knowledge, this is the first multidimensional prospective study of laryngeal reinnervation and also the first to suggest that 3T MRI may be a promising outcome measure for future reinnervation trials. In summary, I have shown that a randomised trial of laryngeal reinnervation versus thyroplasty is feasible in the UK, and have validated patient- and observer-rated outcome measures. I have also shown that MRI may offer an alternative to electromyography in the assessment of laryngeal neuromuscular function in future trials and the clinic.

Type: Thesis (Doctoral)
Title: Laryngeal reinnervation: feasibility studies and development of trial outcome measures
Open access status: An open access version is available from UCL Discovery
Language: English
Keywords: Laryngeal reinnervation, vocal fold paralysis, feasibility, randomised control trial, acoustic analysis, video-laryngeal stroboscopy, T2-weighted MRI, diffusion weighted MRI, dynamic contrast enhanced MRI, cine MRI, vagal nerve tumour
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > The Ear Institute
URI: https://discovery.ucl.ac.uk/id/eprint/1455528
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