Consequence of Unilateral Vestibular Loss on Visual Abilities

NCT03581331 | Completed

• 1 other identifier: 2017-45
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vestibular Schwannoma; Visual Impairment; Vestibular Meniere Syndrome

Outcome Measures

Primary Outcomes (1)

• orthoptic balance

  orthoptic assessment

  30 minutes

Study Arms (1)

acute unilateral vestibular loss

EXPERIMENTAL

patients with acute unilateral vestibular loss by surgical deafferentation will performed an orthoptic balance

Diagnostic Test: orthoptic balance

Interventions

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

acute unilateral vestibular loss

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13005, France

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Vision Disorders

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 10, 2018
• Study Start: February 26, 2018
• Primary Completion: April 30, 2019
• Study Completion: July 13, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

FR (1)