NCT06556160

Fundamental and Clinical Study of Cochlear Synaptopathy

Basic and Clinical Studies of Cochlear Synaptopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: CHU de Reims · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 nerve fibre function. However, this information remains global. The investigators have preliminary data showing that it is possible to extract and characterise the functional properties of nerve fibres during otoneurosurgery in humans, and therefore to isolate the neuronal sub-populations mentioned above more precisely than is currently possible. The use of these electrophysiological data from near-field recordings, i.e. in contact with the nerve, will enable the design and improvement of a mathematical model of the human cochlea. This model will provide access to the individual responses of each nerve fibre and fill the current gap in knowledge between the functioning of these fibres and global surface recordings.

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 be delivered in order to analyze the cochlear electrophysiological signal produced. Depending on the characteristics recorded, this signal can be used at a given frequency and intensity to identify the populations of auditory neurons mainly involved. Prior to surgery, each patient will have been examined by the audiologist in order to determine the auditory thresholds in silence and noise, in tone and in speech, to carry out the digit test and to perform an electrocochleography and distortion products. Each result analyzed will be the subject of a further analysis using the mathematic model of the human cochlea.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
PROCEDURE	near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode	During surgery using a retro-sigmoid approach in the cerebellopontine angle (microvascular decompression), near-field recording of human auditory nerve activity using a contact electrode is performed on patients with normal or impaired hearing threshold. Each patient is explored preoperatively by hearing tests to search synaptopathie. During the surgery, stimuli are delivered.

Timeline

• Start date: 2023-03-21
• Primary completion: 2025-07-16
• Completion: 2025-11-04
• First posted: 2024-08-15
• Last updated: 2025-12-18

Locations

1 site across 1 country: France