Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial

Ann-Margret Ervin, Michael C Schubert, Americo A Migliaccio, Jamie Perin, Hamadou Coulibaly, Jennifer L Millar, Dale Roberts, Mark Shelhamer, Daniel Gold, Stephanie Beauregard, Robin Pinto, Douglas Brungart, Bryan K Ward, INVENT VPT Research Group, Ann-Margret Ervin, Michael C Schubert, Americo A Migliaccio, Jamie Perin, Hamadou Coulibaly, Jennifer L Millar, Dale Roberts, Mark Shelhamer, Daniel Gold, Stephanie Beauregard, Robin Pinto, Douglas Brungart, Bryan K Ward, INVENT VPT Research Group

Abstract

Background: A clinical pattern of damage to the auditory, visual, and vestibular sensorimotor systems, known as multi-sensory impairment, affects roughly 2% of the US population each year. Within the population of US military service members exposed to mild traumatic brain injury (mTBI), 15-44% will develop multi-sensory impairment following a mild traumatic brain injury. In the US civilian population, multi-sensory impairment-related symptoms are also a common sequela of damage to the vestibular system and affect ~ 300-500/100,000 population. Vestibular rehabilitation is recognized as a critical component of the management of multi-sensory impairment. Unfortunately, the current clinical practice guidelines for the delivery of vestibular rehabilitation are not evidence-based and primarily rely on expert opinion. The focus of this trial is gaze stability training, which represents the unique component of vestibular rehabilitation. The aim of the Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) trial is to assess the efficacy of a non-invasive, incremental vestibular adaptation training device for normalizing the response of the vestibulo-ocular reflex.

Methods: The INVENT VPT Trial is a multi-center randomized controlled crossover trial in which military service members with mTBI and civilian patients with vestibular hypofunction are randomized to begin traditional vestibular rehabilitation or incremental vestibular adaptation and then cross over to the alternate intervention after a prescribed washout period. Vestibulo-ocular reflex function and other functional outcomes are measured to identify the best means to improve the delivery of vestibular rehabilitation. We incorporate ecologically valid outcome measures that address the common symptoms experienced in those with vestibular pathology and multi-sensory impairment.

Discussion: The INVENT VPT Trial will directly impact the health care delivery of vestibular rehabilitation in patients suffering from multi-sensory impairment in three critical ways: (1) compare optimized traditional methods of vestibular rehabilitation to a novel device that is hypothesized to improve vestibulo-ocular reflex performance, (2) isolate the ideal dosing of vestibular rehabilitation considering patient burden and compliance rates, and (3) examine whether recovery of the vestibulo-ocular reflex can be predicted in participants with vestibular symptoms.

Trial registration: ClinicalTrials.gov NCT03846830 . Registered on 20 February 2019.

Keywords: Dizziness; Imbalance; Incremental vestibular adaptation; Service members, Traumatic brain injury; Vestibular rehabilitation; Vestibulo-ocular reflex.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
A participant wearing the head unit of the IVE training device. The base unit illustrates the configuration screens
Fig. 2
Fig. 2
Algorithm of aim I comparing IVE with VPT, considering 6-week washout and crossover design. Both groups get gait/balance exercises from the beginning. CPG, clinical practice guidelines [17]
Fig. 3
Fig. 3
Algorithm of aim II examining how training gaze stability alone impacts improvement considering 3-week washout and crossover design. Gait/balance exercises do not start until after the washout

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Source: PubMed

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