Integrative Study of Vestibular Pathology (SENSORIEL2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dizziness; Syndrome
• Intervention / Treatment: Other: Neurosensory

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • Recruiting
    • CAEN University Hospital
  • Vitrolles, France, 13127
    • Recruiting
    • Frédéric Xavier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: patient; One cohort of patients	Other: Neurosensory; Physiological and neurophysiological investigations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posture	postural measurement	through follow-up, an average of 6 months
Cognition	Spatial cognitive performance in a calibrated virtual radial maze	through follow-up, an average of 6 months
Personnality characteristic	Evaluation of the BIg Five inventory test	through follow-up, an average of 6 months
Sleep	Quantitative sleep recording	through follow-up, an average of 6 months
Emotion	Anxiety measurement via questionnary	through follow-up, an average of 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2022
• Primary Completion (ANTICIPATED): January 31, 2026
• Study Completion (ANTICIPATED): January 31, 2026

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (ACTUAL): September 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: vertigo; cognition; emotion; balance; posture; vestibular system; physiotherapist
• Additional Relevant MeSH Terms: Neurologic Manifestations; Sensation Disorders; Dizziness
• Other Study ID Numbers: 2020-A02956-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No