Integrative Study of Vestibular Pathology

NCT ID: NCT05525728

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-18

Study Completion Date

2026-01-31

Brief Summary

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Exploratory posturological, neurosensory, cognitive, emotional, personality and general evaluations (quality of life).

The investigators will characterize a sensory profile quantified by one or more scores from a multi-parameter baysian approach. Each parameter and these scores will be correlated to the type of vestibular damage and its recovery in order to establish diagnostic, prognostic and therapeutic follow-up markers.

Detailed Description

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This is an exploratory neurophysiological work that aims to identify diagnostic, prognostic and therapeutic markers in vestibular pathology.

Theinvestigators wish to characterize the neurosensory profile of individuals using new exploration paradigms provided by a new posturology platform coupled with virtual reality scenarios and by proposing a complete transversal approach in terms of evaluation of the subjects: personality, cognition, emotion including the depressive state, sensory strategy, general data.

Baysian statistical approaches and linear mixed model will be used to determine markers of sensory profile correlated to the vestibular damage for diagnostic, prognostic and therapeutic follow-up.

The investigators aim to be able to better characterize the cognitive-emotional and sensory deficits expressed by the vertiginous and unstable patients, to integrate it into the evaluation of the vestibular pathology, to use these markers to better discriminate the underlying physiopathological mechanisms, and to improve at the same time the diagnosis of the functional attack and the rehabilitation follow-up of the patients.

Conditions

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Dizziness; Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

a group of patient suffering from vestibular pathology will be investigated regardless the etiology of the vertigo or dizziness
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patient

One cohort of patients

Group Type OTHER

Neurosensory

Intervention Type OTHER

Physiological and neurophysiological investigations

Interventions

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Neurosensory

Physiological and neurophysiological investigations

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female patient (18-80 years old)
* Patient with an acute or chronic vestibular pathology according to ENT diagnostic criteria

Exclusion Criteria

* Subjects under 18 years of age
* Pregnant or breastfeeding women,
* Persons in an emergency situation or unable to give their consent, including adults under guardianship
* Person under legal protection
* Patient presenting a vertigo or postural disorders of non vestibular etiology
* Persons deprived of liberty, minors, protected adults,
* Patients with an intercurrent neurological pathology including cerebellar pathology
* Inclusion of the subject in another interventional research protocol with pharmacological aim during the present study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Stéphane BESNARD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Caen University Hospital

Caen, , France

Site Status RECRUITING

Frédéric Xavier

Vitrolles, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Stéphane BESNARD, MD, PhD

Role: primary

+33231065332

Frédéric XAVIER, PhD

Role: primary

+33231065332

Other Identifiers

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2020-A02956-33

Identifier Type: -

Identifier Source: org_study_id

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