Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06164483

Auditory Functions in Patients With Multiple Sclerosis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Ear Diseases Hearing Disorders Immune System Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arianna Di Stadio

Catania, Sicily, 95121, Italy

Location status: Recruiting

Location contact

Arianna Di Stadio, MD, PhD

CONTACT

[email protected]

095/123546

Athanasia Warnecke, MD, PhD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory test

Diagnostic 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

CSF sampling

Other

Cerebrospinal Fluid will be collected by lumbar puncture and analyzed

Primary outcomes

  1. Auditory functions and correlation with CSF findings

    Time frame: 12 months

    The worsening of the hearing thresholds and DPOAE results will be correlated with the presence of inflammatory elements in the CSF

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Collaborators

  • Hannover Medical School

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 11, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.