Auditory Functions in Patients With Multiple Sclerosis

Recruiting

• Conditions: Multiple Sclerosis; Hearing Disorders
• Interventions: Diagnostic Test: Auditory test; Other: CSF sampling

• Registration Number: NCT06164483
• Lead Sponsor: University of Catania

Brief Summary

The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). CSF will be collected by lumbar puncture and analyzed looking for inflammatory markers.

The results of DPOAE and CSF will be correlated to identify statistically significant correlation.

Detailed Description

Case-Control study

Tools for patients' selection and inclusion in the study

STEP one

* Full medical records detailed for neurological diseases

* Brain and spinal cord MRI performed 12 months (n1) before and most recent one (n2)

* Lumbar puncture

* Blood test

* Questionnaire for screening hearing disorders

* App for screening hearing loss

STEP two

* Pure Tone Auditory test + Tympanometry and Stapedial Reflex

* Speech Perception test

* In case of tinnitus: tinnitus questionnaire and acuphenometry

* DPOAEs

* ABR

STEP three in case of Hearing impairment

- MRI Tractography

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MS group	Auditory test	Patient with Relapsing Remitting MS age between 20 and 40 years
MS group	CSF sampling	Patient with Relapsing Remitting MS age between 20 and 40 years
Control	Auditory test	Healthy patients between 20 and 40 years
Control	CSF sampling	Healthy patients between 20 and 40 years

Primary Outcome Measures

Name	Time	Method
Auditory functions and correlation with CSF findings	12 months	The worsening of the hearing thresholds and DPOAE results will be correlated with the presence of inflammatory elements in the CSF

Trial Locations

Locations (1)

Arianna Di Stadio; 🇮🇹 Catania, Sicily, Italy