A mixed methods randomised feasibility trial investigating the management of benign paroxysmal positional vertigo in acute traumatic brain injury

Pilot and Feasibility Studies

Rebecca M. Smith¹  Barry M. Seemungal²  Vassilios Tahtis³  Jenna Beattie⁴  Natalie Marroney⁴  Caroline Burgess⁵  Jonathan Marsden⁶  Abby Newdick⁷ 

[1] Brain And Vestibular Group (BAVG), Neuro-otology Unit, Department of Brain Sciences, Imperial College London, London, UK;Brain And Vestibular Group (BAVG), Neuro-otology Unit, Department of Brain Sciences, Imperial College London, London, UK;Imperial College Healthcare NHS Trust, London, UK;Brain And Vestibular Group (BAVG), Neuro-otology Unit, Department of Brain Sciences, Imperial College London, London, UK;King’s College Hospital NHS Foundation Trust, London, UK;Imperial College Healthcare NHS Trust, London, UK;Population of Health Sciences, King’s College London, London, UK;School of Health Professions, University of Plymouth, Plymouth, UK;St George’s University Hospitals NHS Foundation Trust, London, UK;

关键词: Feasibility study;    Traumatic brain injury;    Benign paroxysmal positional vertigo;    Rehabilitation;   

DOI  :  10.1186/s40814-020-00669-z

来源: Springer

【 摘 要 】

BackgroundTraumatic brain injury (TBI) is the leading cause of long-term disability in working age adults. Recent studies show that most acute TBI patients demonstrate vestibular features of dizziness and imbalance, often from combined peripheral and central vestibular dysfunction. Effective treatment for vestibular impairments post-TBI is important given its significant adverse impact upon quality of life and employment prospects. The most frequent peripheral vestibular disorder in acute TBI is benign paroxysmal positional vertigo (BPPV), affecting approximately half of acute cases. Although there is effective treatment for idiopathic BPPV, there are no high-quality clinical data for post-TBI BPPV regarding its prevalence, natural history, which treatment is most effective and when is the best time to treat. In particular, observational studies suggest post-TBI BPPV may be recurrent, indicating that hyperacute treatment of BPPV may be futile. Given the potential hurdles and the lack of accurate post-TBI BPPV data, the current study was designed to provide information regarding the feasibility and optimal design of future large-scale prospective treatment studies that would compare different interventions and their timing for post-TBI BPPV.MethodA multi-centre randomised mixed methods feasibility study design was employed. We aim to recruit approximately 75 acute TBI patients across a range of clinical severities, from three major trauma centres in London. Patients will be randomised to one of three treatment arms: (1) therapist-led manoeuvres, (2) patient-led exercises and (3) advice. Participants will be re-assessed by blinded outcome assessors at 4 and 12 weeks. Acceptability of the intervention will be obtained by patient interviews at the end of their treatment and therapist interviews at the end of the study. Primary outcomes relate to feasibility parameters including recruitment and retention rates, adverse events and intervention fidelity. We will also aim to provide a more accurate estimate of the prevalence of BPPV in TBI cases on the trauma ward.DiscussionThe multi-centre nature of our feasibility study will inform the design of a future prospective treatment trial of BPPV in acute TBI. Important parameters we will obtain from this study, key for designing a future prospective treatment study, include estimating the prevalence of BPPV in TBI patients admitted to UK major trauma wards, and elucidating both patient and care-provider barriers in delivering BPPV treatment.Trial registrationISRCTN, ISRCTN91943864. Registered on 10 February 2020.

【 授权许可】

CC BY