Study Results
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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RECRUITING
30 participants
OBSERVATIONAL
2023-10-01
2025-12-30
Brief Summary
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The results of DPOAE and CSF will be correlated to identify statistically significant correlation.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control
Healthy patients between 20 and 40 years
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
CSF sampling
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
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
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
CSF sampling
Cerebrospinal Fluid will be collected by lumbar puncture and analyzed
Eligibility Criteria
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Inclusion Criteria
* 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
* stroke \< 2 years
* cardiovascular disease non under control
* diabetes
* hypotensive disorders
* alcohol abuse
* recreational drug consumption
* epilepsy
20 Years
40 Years
ALL
Yes
Sponsors
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Hannover Medical School
OTHER
University of Catania
OTHER
Responsible Party
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Arianna Di Stadio
Associate Professor fixed time
Locations
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Arianna Di Stadio
Catania, Sicily, Italy
Countries
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Facility Contacts
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Other Identifiers
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MSSNHL2023
Identifier Type: -
Identifier Source: org_study_id
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