Auditory Functions in Patients With Multiple Sclerosis

University of Catania

Status: Enrolling

Conditions: Hearing Disorders; Multiple Sclerosis

Treatments: Other: CSF sampling; Diagnostic Test: Auditory test

Study type: Observational

Funder types: Other

Identifiers

NCT06164483

MSSNHL2023

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

30 participants in 2 patient groups

Control

Description:

Healthy patients between 20 and 40 years

Treatment:

Diagnostic Test: Auditory test

Other: CSF sampling

MS group

Description:

Patient with Relapsing Remitting MS age between 20 and 40 years

Treatment:

Diagnostic Test: Auditory test

Other: CSF sampling