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Meniere Disease clinical trials

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NCT ID: NCT03581331 Completed - Visual Impairment Clinical Trials

Consequence of Unilateral Vestibular Loss on Visual Abilities

SVorthoptie
Start date: February 26, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03325790 Completed - Meniere's Disease Clinical Trials

SPI-1005 for the Treatment of Patients With Meniere's Disease

Start date: September 28, 2017
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.

NCT ID: NCT03215420 Completed - Clinical trials for Endolymphatic Hydrops

Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease

MRI Meniere
Start date: September 8, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH). The research hypothesis is that the examinations will show agreement in the diagnosis of EH, and that the results obtained (quantitative values) will vary in the same direction over time and during flares of MD.

NCT ID: NCT02718846 Completed - Meniere's Disease Clinical Trials

Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

Start date: February 2013
Phase: Phase 4
Study type: Interventional

A multicenter, randomized, open-label clinical study with a concurrent control group to assess the effectiveness and safety of combined therapy with Isobide solution and Meniace tablets compared to monotherapy with Meniace tablets for patients with Meniere's disease

NCT ID: NCT02612337 Completed - Meniere's Disease Clinical Trials

Study of OTO-104 in Subjects With Unilateral Meniere's Disease

AVERTS-1
Start date: October 27, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

NCT ID: NCT02603081 Completed - Meniere's Disease Clinical Trials

Study to Evaluate SPI-1005 in Adults With Meniere's Disease

Start date: December 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

NCT ID: NCT02309099 Completed - Meniere's Disease Clinical Trials

Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach

Start date: November 2014
Phase: N/A
Study type: Interventional

The goal of this project is to determine whether subjects who have undergone labyrinthectomy or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or Meniere's disease benefit from cochlear implantation on speech perception and localization tasks. If the auditory nerve is able to transmit this signal effectively, then these two populations may be able to utilize the combination of electric (in the affected ear) and acoustic (in the non-affected ear) information for improved speech perception in noise and localization as reportedly experienced in other unilateral sensorineural hearing loss populations.

NCT ID: NCT02265393 Completed - Meniere's Disease Clinical Trials

A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom

Start date: October 2014
Phase: Phase 2
Study type: Interventional

This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.

NCT ID: NCT02158585 Completed - Meniere's Disease Clinical Trials

Study of Lamotrigine to Treat Ménière's Disease

Start date: June 2014
Phase: Phase 2
Study type: Interventional

This double-blinded study evaluates the frequency of vertigo attacks and the quality of life of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo or lamotrigine.

NCT ID: NCT02080312 Completed - Meniere's Disease Clinical Trials

Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent

Start date: January 2012
Phase: N/A
Study type: Interventional

This is a pilot study of patients with clinical symptoms of Ménière's disease using injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear structures. The goal is to reproduce imaging findings described by non-United States (US) institutions, improve on image quality with decreased scan time and evaluate the dynamics of the contrast movement into the inner ear structures.