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RecruitingNCT06164483

Auditory Functions in Patients With Multiple Sclerosis

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
University of Catania · Academic / Other
Sex
All
Age
20 Years – 40 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTAuditory testThe 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 samplingCerebrospinal Fluid will be collected by lumbar puncture and analyzed

Timeline

Start date
2023-10-01
Primary completion
2024-12-30
Completion
2025-12-30
First posted
2023-12-11
Last updated
2024-05-08

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06164483. Inclusion in this directory is not an endorsement.