Fundamental and Clinical Study of Cochlear Synaptopathy (NCT06556160) | Clinical Trial Compass
CompletedNot Applicable
Fundamental and Clinical Study of Cochlear Synaptopathy
France19 participantsStarted 2023-03-21
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
In response to a stimulus, the neurophonic potential recorded in the form of a wave called PSTR will be characterised patients defined as normo and hearing loss based on preoperative audiometric tests
Timeframe: At 48 months
2
Compare the amplitude and spectrum of global evoked auditory nerve activity with basic stimuli between patients defined as normo and hearing loss based on preoperative audiometric tests