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Completed

NCT Number: NCT03581331

Consequence of Unilateral Vestibular Loss on Visual Abilities

Unilateral vestibular lesions are frequent and disabling pathologies causing a set of oculomotor, postural and perceptual symptoms. These symptoms reduce over time according to a vestibular compensation. However, vestibular compensation should be considered as a set of sub-processes whose duration and recovery level differ. Indeed, after a unilateral vestibular loss, some functions remain asymmetrical as a long-term effect, and these disorders may be observed among patients with no functional complaints. Balance disorders may persist in some patients.

The equilibration consists in handling real-time a considerable amount of information coming from the environment and the subject himself, allowing an adaptation of the position and movements of his body to satisfy the needs of posture, balance and orientation. This information comes mainly from the vision, the vestibule and the somesthesic system. It is pre-treated and harmonized in the brainstem, before being transmitted to the higher brain centres. Brain centers thus learn about peripheral conditions. According to these and the project of the movement, brain centers address in response orders to ophtalmological and motor effectors ensuring look, posture and balance to be provided. The eye is a cornerstone of the balancing system through the retina, an environmental sensor, and its extraocular muscles, effectors of the system.

The aim of this study is to assess the effects of acute unilateral vestibular loss on visual abilities evaluated by orthoptic balance in patients who presented acute unilateral vestibular loss by surgical deafferentation (removal of vestibular schwannoma, vestibular neurotomy or surgical labyrinthectomy for Meniere's disease), during the early phase and decline of vestibular compensation.

Our secondary objective is to evaluate the effect of a pre-existing anomaly of the visual abilities evaluated by orthoptic assessment on the vestibular compensation capacities.

All in all, this study seems crucial to improve the management of patients with unilateral vestibular dysfunction and contribute to improving their clinical management.

As a standardized management of these patients, an audio-vestibular evaluation will be performed before surgery (-1D), after acute unilateral vestibular loss at the early stage (+7D), and then after vestibular compensation (+2M) as well as an orthoptic evaluation. A good tolerance of the orthoptic evaluation is expected in this surgical context.

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Key information

About this study

Unilateral vestibular lesions are frequent and disabling pathologies, with significant psychological impacts, as well as on the socio-professional and daily life of the affected subjects. Furthermore, socio-economic consequences have to be considered.

The involvement of the vestibular system in the stabilization control of the look, the eye-head coordination, posture, locomotion and perception of verticality is widely recognized. Therefore, the unilateral vestibular diseases cause a set of oculomotor, postural and perceptual symptoms. These symptoms reduce over time according to a process known as vestibular compensation. However, vestibular compensation should be considered as a set of sub-processes whose duration and recovery level differ. Indeed, after a unilateral vestibular loss, some functions remain asymmetrical as a long-term effect, and these disorders may be observed among patients with no functional complaints. Balance disorders may persist in some patients.

The equilibration consists in handling real-time a considerable amount of information coming from the environment and the subject himself, allowing an adaptation of the position and movements of his body to satisfy the needs of posture, balance and orientation. This information comes mainly from the vision, the vestibule and the somesthesic system. It is pre-treated and harmonized in the brainstem, before being transmitted to the higher brain centres. Brain centres thus learn about peripheral conditions. According to these and the project of the movement, brain centers address in response orders to ophtalmological and motor effectors ensuring look, posture and balance to be provided. The eye is a cornerstone of the balancing system through the retina, an environmental sensor, and its extraocular muscles, effectors of the system.

The aim of this study is to assess the effects of acute unilateral vestibular loss on visual abilities evaluated by orthoptic balance in patients who presented acute unilateral vestibular loss by surgical deafferentation (removal of vestibular schwannoma, vestibular neurotomy or surgical labyrinthectomy for Meniere's disease), during the early phase and decline of vestibular compensation.

Our secondary objective is to evaluate the effect of a pre-existing anomaly of the visual abilities evaluated by orthoptic assessment on the vestibular compensation capacities.

All in all, this study seems crucial to improve the management of patients with unilateral vestibular dysfunction and contribute to improving their clinical management by prescribing an appropriate rehabilitation.

As a standardized management of these patients, an audio-vestibular evaluation (clinical ENT examination, pure tone and speech audiometry, videonystagmography, vestibular evoked myogenic potentials, Posturography, Vertical Visual Subjective, quality of life by Dizziness Handicap Inventory) will be performed before surgery (-1D), after acute unilateral vestibular loss at the early stage (+7D), and then after vestibular compensation (+2M).

An orthoptic evaluation will be performed during 30 min and the audio vestibular evaluation will be carried out at the same time. A good tolerance of the orthoptic evaluation is expected in this surgical context.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with unilateral vestibular loss by programmed surgical deafferentiation: excision of vestibular schwannoma, vestibular neurotomy, or surgical labyrinthectomy for Meniere's disease
  • Age between 18 and 80 years old.
  • Women should not be pregnant or breastfeed; postmenopausal women can be included.
  • A subject willing and able to give informed consent and to respect the requirements of the protocol.
  • Affiliated with the French Social Security.

Exclusion criteria

  • contralateral vestibular isflexia
  • Central vestibular syndrome (stroke, intraparenchymal cerebral tumor, multiple sclerosis ...)
  • Uni- or bilateral blindness
  • Motor deficit
  • Major medical or psychiatric illness that, in the opinion of the investigator, would pose a risk to or could compromise compliance with the study protocol.
  • Legal incapacity or limited legal capacity.

Treatment and study plan

orthoptic balance

Diagnostic Test

Measurement of visual acuity by far: Monocular measurement, right eye, left eye and binocular Measurement of visual acuity closely: Monocular measurement, right eye, left eye and binocular Corneal reflection method or Hirschberg: Analysis of the corneal reflection after fixation of a point of fixation of light from a distance, then from near.

Cover-Test: Study of the restitution movement following the fixation of the fixation point

Primary outcomes

  1. orthoptic balance

    Time frame: 30 minutes

    orthoptic assessment

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: SVorthoptie

Important dates

Study start
2018
Primary completion
2019
Study completion
2023
First posted
Jul 10, 2018
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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