Damien JOLLY
Reims, France
NCT Number: NCT06556160
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Reims, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with normal hearing will be included:
Patients with a hearing impairment will be included:
Exclusion criteria
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.
Time frame: At 48 months
During ponto cerebellum retro sigmoide surgery. 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 by the following indices:- the amplitude of the peak- the amplitude of the plateau- the peak to plateau ratio- the time constant for the rapid decay of the peak- the time constant for the slow decay of the peak.
Time frame: At 48 months
During ponto cerebellum retro sigmoide surgeryelectrocochleography and distortion products.
Time frame: At 48 months
During ponto cerebellum retro sigmoide surgery
CHU de Reims
Other
Basic and Clinical Studies of Cochlear Synaptopathy
Acronym: FunCoSy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04183348
Cochlear Diseases, Cochlear Hearing Loss
Bron, France
View Trial DetailsNCT04754477
Deafness, Ear Diseases
Gladesville, New South Wales, Australia
View Trial DetailsNCT02561091
Communication Disorders, Deafness
Sofia, Bulgaria
View Trial DetailsNCT04454255
Deafness, Ear Diseases
Geneva, Switzerland
View Trial Details