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

Abstract

Background Traumatic 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. Method A 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. Discussion The 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 registration ISRCTN, ISRCTN91943864. Registered on 10 February 2020.

Brain Mechanisms Explaining Postural Imbalance in Traumatic Brain Injury: A Systematic Review

“…Even though the cross-sectional studies of moderate-severe TBI in this review had average time of circa three years from injury to testing, some patients were also tested as early as four months after the injury (Diez et al, 2017;Drijkoningen et al, 2015a;Drijkoningen et al, 2015b). Notably, previously reported recurrence rate of BPPV was up to 67% in TBI (Calzolari et al, 2021;Gordon et al, 2004), which was supplemented by recent studies showing that recurrence can occur in a period ranging from up to four (Smith et al, 2020) to six months (Hadi et al, 2023in preparation; recurrence rate of 31.6%) post-TBI. It follows that any study aiming to understand the brain correlates of imbalance should assess all these clinical features both acutely and at follow-up to exclude or treat patients for these additional vestibular diagnoses, prior to balance and imaging assessment.…”

Treating benign paroxysmal positional vertigo in acute traumatic brain injury: a prospective, randomised clinical trial assessing safety, feasibility, and efficacy

“…The published research protocol contains more methodological details. 20 Data regarding clinicians’ and patients’ views on the acceptability of trial procedures, critical for the future implementation of BPPV treatment in acute TBI, will be reported separately.…”

“…As per the published protocol, therapists were trained in using the Epley and Semont manoeuvres for posterior canal BPPV, and the log roll manoeuvre for horizontal canal BPPV. 20 Following treatment, therapists re-assessed patients during their in-patient stay to evaluate their response to treatment, including the possibility of canal conversion. Participants were not instructed to complete self-manoeuvres at home.…”