Auditory Functions in Patients With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auditory test, CSF sampling.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Hearing Disorders. Basic parameters: 20 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Electrophysiological Studies of Auditory Functions and CSF Analyses in Patients With Multiple Sclerosis
Overview
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 test 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 - Other CSF sampling
Cerebrospinal Fluid will be collected by lumbar puncture and analyzed
Primary outcome measures
- Auditory functions and correlation with CSF findings [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Arianna Di Stadio — Catania
Identifiers
NCT: NCT06164483 · MSSNHL2023