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Fundamental and Clinical Study of Cochlear Synaptopathy

NCT ID: NCT06556160

Last Updated: 2025-12-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2025-11-04

Brief Summary

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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

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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

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Hearing Loss

Keywords

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Hearing Loss Deafness Micro vascular decompression otoneurosurgery retrosigmoid approach

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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hearing impaired patients

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.

Group Type EXPERIMENTAL

near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode

Intervention Type PROCEDURE

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.

normal hearing patients

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

Group Type ACTIVE_COMPARATOR

near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status

Countries

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France

Other Identifiers

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PO23045

Identifier Type: -

Identifier Source: org_study_id