Status:
COMPLETED
Fundamental and Clinical Study of Cochlear Synaptopathy
Lead Sponsor:
CHU de Reims
Conditions:
Hearing Loss
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
In humans, surface electrophysiological recording of the cochlear nerve in response to a sound stimulus provides information about the integrity and function of synapses (synaptic transmission) and ne...
Detailed Description
During functional surgery on the cerebellopontine angle, a ball electrode is placed on the human cochlear nerve to monitor hearing. Once the electrode is in place, clicks and random noise bands will b...
Eligibility Criteria
Inclusion
- inclusion criteria :
- Patients with normal hearing will be included:
- male or female
- over 18 and up to 70 years of age
- normal otoscopic examination
- due to undergo surgery on the cerebellopontine angle (microvascular decompression).
- free of neuro-sensory deafness, defined by mean hearing thresholds of less than or equal to 20 dB HL in pure tone audiometry in air conduction bilaterally on the side of the ear operated on and on the non-operated side from 0.25 to 8 kHz
- affiliated to a social security scheme
- have read the information note describing the study and have agreed in writing to take part by signing the informed consent form.
- Patients with a hearing impairment will be included:
- male or female
- over 18 and up to 70 years of age
- normal otoscopic examination
- due to undergo surgery on the cerebellopontine angle (microvascular decompression).
- have a sensorineural hearing loss defined by hearing thresholds of 20 dB HL or better from 0.25 to 2 kHz and from 20 dB HL excluded to 55 dB HL at frequencies above 2 kHz.
- have read the information note describing the study and have agreed in writing to take part by signing the informed consent form.
- exclusion criteria :
- \- Patients will be excluded from the study for whom the auditory nerve is not accessible during surgery, in particular because of complete tumour invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma) or because of a particular anatomical feature not identified during the preoperative examination, making it impossible to expose the nerve for recordings (protrusion of the posterior surface of the rock).
Exclusion
Key Trial Info
Start Date :
March 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06556160
Start Date
March 21 2023
End Date
November 4 2025
Last Update
December 18 2025
Active Locations (1)
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1
Damien JOLLY
Reims, France