Trials / Recruiting
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
| Type | Name | Description |
|---|---|---|
| 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 |
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.