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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hearing Disorders
• Multiple Sclerosis
• Sclerosis

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