Auditory Functions in Patients With Multiple Sclerosis

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06164483

Enrollment

Registered

2023-12-11

Start date

2026-05-11

Completion date

2028-12-30

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Disorders, Multiple Sclerosis

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

Interventions

DIAGNOSTIC_TESTAuditory 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

OTHERCSF sampling

Cerebrospinal Fluid will be collected by lumbar puncture and analyzed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026