Actively Recruiting

Age: 20Years - 40Years
All Genders
Healthy Volunteers
ID06164483

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

Led by University of Catania · Updated on 2026-05-12

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Catania

Lead Sponsor

H

Hannover Medical School

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating auditory functions in patients with Multiple Sclerosis (MS) by using various hearing tests and analyzing cerebrospinal fluid (CSF) for inflammatory markers. This observational case-control study compares healthy adults and adults with Relapsing Remitting MS, aiming to find correlations between auditory test results and CSF findings to better understand hearing issues related to MS. Participants will undergo several auditory tests including Pure Tone Auditory test, Tympanometry, Stapedial Reflex, Speech Perception test, and if applicable, tinnitus-related questionnaires and acuphenometry. Additionally, Distortion Product Otoacoustic Emissions (DPOAEs) and Auditory Brain Response (ABR) tests will be performed. CSF will be collected via lumbar puncture for analysis. MRI tractography is performed if hearing impairment is detected. Participants' involvement includes screening through medical records, MRI scans, blood tests, and hearing loss questionnaires. They will undergo the auditory tests and CSF sampling as described. Researchers will measure auditory function and its correlation with CSF results over 12 months. The study includes healthy volunteers and MS patients aged 20 to 40 years, with ongoing monitoring of auditory function and neurological status.

CONDITIONS

Brief Title

Auditory Functions in Patients With Multiple Sclerosis

Who Can Participate

Age: 20Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 and under 50 years
  • No history of hearing loss
  • No psychiatric conditions
  • No family history of otosclerosis, deafness, or genetic hearing loss
  • Diagnosis of Parkinson's disease and/or Multiple Sclerosis
Not Eligible

You will not qualify if you...

  • Conductive hearing loss
  • Stroke within the last 2 years
  • Uncontrolled cardiovascular disease
  • Diabetes
  • Hypotensive disorders
  • Alcohol abuse
  • Recreational drug use
  • Epilepsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 12 months

Participants undergo auditory tests including Pure Tone Auditory test, Tympanometry and Stapedial Reflex, Speech Perception test, and additional assessments if tinnitus is present. Cerebrospinal Fluid is collected by lumbar puncture for analysis.

1 to 2 visits including auditory tests and lumbar puncture

Imaging Visits

Duration - Single visit as needed

For participants with hearing impairment, MRI tractography is performed to assess auditory pathways.

1 visit (in-person) if hearing impairment is detected

Long-term Monitoring

Duration - 12 months

Participants are observed for auditory functions and their correlation with cerebrospinal fluid findings over 12 months.

Follow-up assessments as scheduled

Trial Site Locations

Total: 1 location

1

Arianna Di Stadio

Catania, Sicily, Italy, 95121

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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