Auditory Functions in Patients With Multiple Sclerosis

NCT ID: NCT06164483

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-30

Brief Summary

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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

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Case-Control study

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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

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Multiple Sclerosis Hearing Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Healthy patients between 20 and 40 years

Auditory test

Intervention Type 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

Intervention Type OTHER

Cerebrospinal Fluid will be collected by lumbar puncture and analyzed

MS group

Patient with Relapsing Remitting MS age between 20 and 40 years

Auditory test

Intervention Type 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

Intervention Type OTHER

Cerebrospinal Fluid will be collected by lumbar puncture and analyzed

Interventions

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Auditory 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

Intervention Type DIAGNOSTIC_TEST

CSF sampling

Cerebrospinal Fluid will be collected by lumbar puncture and analyzed

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hannover Medical School

OTHER

Sponsor Role collaborator

University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Arianna Di Stadio

Associate Professor fixed time

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Arianna Di Stadio

Catania, Sicily, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Arianna Di Stadio, MD, PhD

Role: primary

095/123546

Other Identifiers

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MSSNHL2023

Identifier Type: -

Identifier Source: org_study_id

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