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NCT06164483 Clinical Trial

Auditory Functions in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:
Electrophysiological Studies of Auditory Functions and CSF Analyses in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06164483
Other study ID # MSSNHL2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date December 30, 2025

Study information
Verified date May 2024
Source University of Catania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria - age >18 and <50, - no history of hearing loss, - no psychiatric condition - no familial history of otosclerosis/deafness/genetic hearing loss - patients with PD and/or MS. Exclusion Criteria - Conductive hearing loss - stroke < 2 years - cardiovascular disease non under control - diabetes - hypotensive disorders - alcohol abuse - recreational drug consumption - epilepsy

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Auditory test
The patients will perform: Pure Tone Auditory test + Tympanometry and Stapedial Reflex Speech Perception test In case of tinnitus: tinnitus questionnaire and acuphenometry DPOAEs ABR
Other:
• CSF sampling
Cerebrospinal Fluid will be collected by lumbar puncture and analyzed

Locations
Country Name City State
Italy Arianna Di Stadio Catania Sicily

Sponsors (2)
Lead Sponsor Collaborator
University of Catania Hannover Medical School

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Auditory functions and correlation with CSF findings The worsening of the hearing thresholds and DPOAE results will be correlated with the presence of inflammatory elements in the CSF 12 months
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