Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales (PERSOCOR)

Depersonalization-derealization (DD) disorders are a clinical phenomenon characterized by feeling disconnected or detached from one's self. Individuals may report feeling as if they are an outside observer of their own thoughts or body, and often report feeling a loss of control over their thoughts or actions.

Several scales have been developed to measure DD, and the Cambridge Depersonalization Scale (CDS) appears to be the most relevant and consistent to characterize the clinical symptoms of these disorders as well as their duration and frequency. This scale, originally written in English, must be translated and validated according to standardized methods that include testing steps patients with dizziness and in individuals with no vestibular disorder.

Persistent postural-perceptual dizziness (PPPD) is a chronic, persistent vestibular syndrome generally preceded by acute vestibular disorders. The main symptoms are rotational dizziness, unsteadiness and / or non-rotating dizziness that are exacerbated by upright posture, walking, active or passive movement, and exposure to moving visual stimuli or complex visual patterns. To help diagnose this syndrome, a questionnaire was developed in Japan in 2019, the Niigata questionnaire, however no French version has yet been validated. Similarly, this scale needs to be validated in patient with PPPD and in control populations.

The main objective of this study is to validate the French translation of these two scales, the CDS questionnaire and the Niigata PPPD questionnaire, according to standard methods (forward translation, back translation, consensus).

Study Overview

• Status: Recruiting
• Conditions: Patients With Acute or Chronic Otoneurological Disorders; Patients Presenting or Having Experienced Dizziness and / or Balance Disorders
• Intervention / Treatment: Other: Questionnaire Measures

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Recruiting
    • Hôpital Européen Marseille
    • Contact: Myriam BENNANI; Phone Number: 04 13 42 83 51; Email: m.bennani@hopital-europeen.fr
    • Principal Investigator: Maya ELZIERE, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

For patient:

• Age ≥ 18 years
• Patient with acute or chronic otoneurological disorders
• Patient having or having experienced dizziness and / or balance disorders
• Patient with PPPD
• Fluency in French
• Having given free and informed written consent
• Being affiliated with or benefiting from social security

For control subjects:

• Age ≥ 18 years
• Fluency in French
• Having given free and informed written consent
• Being affiliated with or benefiting from social security.

Exclusion Criteria:

For patient:

-Past or present psychiatric and neurological disease (other than otoneurological or PPPD, as declared by the participant)

For control subjects:

-Past or present psychiatric and neurological disease (as declared by the participant) and vestibular and/or auditory system disorders (as declared by the participant)

For all participants:

• Persons still in a period of exclusion from another study and persons simultaneously participating in another study
• Subject to a measure for the protection of justice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control subjects	Other: Questionnaire Measures; Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)
Experimental: Patients; Patients with acute or chronic otoneurological disorders, presenting or having experienced dizziness and / or balance disorders	Other: Questionnaire Measures; Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Scores from the CDS questionnaire translated according to standardized methods (forward translation, back translation, consensus) in patients with other vestibular disorders and control subjects.	24 months
Scores from the Niigata PPPD questionnaire translated according to standardized methods (forward translation, back translation, consensus) in patients with PPPD, patients with other vestibular disorders and control subjects.	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of the HADS score in patients with PPPD, in patients with other vestibular disorders and in control subjects	24 months
Measurement of the DHI score in patients with PPPD, patients with other vestibular disorders and control subjects	24 months

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neurologic Manifestations; Sensation Disorders; Disease; Dizziness
• Other Study ID Numbers: 21-44

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