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Clinical Trials/NCT05525728
NCT05525728
Recruiting
Not Applicable

Integrative Study of Vestibular Pathology With Analysis of Postural, Neurosensory, and Cognitive Disorders: Search for New Markers on the Causes and Consequences of Vertigo

University Hospital, Caen2 sites in 1 country80 target enrollmentJune 18, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dizziness; Syndrome
Sponsor
University Hospital, Caen
Enrollment
80
Locations
2
Primary Endpoint
Cognition
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 18, 2022
End Date
January 31, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stéphane BESNARD

Associate professor

University Hospital, Caen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cognition

Time Frame: through follow-up, an average of 6 months

Spatial cognitive performance in a calibrated virtual radial maze

Posture

Time Frame: through follow-up, an average of 6 months

postural measurement

Personnality characteristic

Time Frame: through follow-up, an average of 6 months

Evaluation of the BIg Five inventory test

Sleep

Time Frame: through follow-up, an average of 6 months

Quantitative sleep recording

Emotion

Time Frame: through follow-up, an average of 6 months

Anxiety measurement via questionnary

Study Sites (2)

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