Evaluation of the Global Auditory Nerve Activity for Exploration of Hearing in Humans (MELAUDI-2)

Evaluation of the Global Auditory Nerve Activity as a New Method of Electrophysiological Exploration of Hearing in Humans - 2

To date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. This measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained activity. This can explain why in experimental models, a loss of more of 80% of auditory nerve fibbers cannot be detected by usual electrophysiological measurements. In this study we aim at investigating the global spontaneous and sound evoked auditory nerve activity by recording directly the electrical field by an electrode placed directly on the auditory nerve of subjects during a skull base surgical procedure. We expected to demonstrated differences in the electrical activity between subjects with or without hearing loss.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Procedure: Recording of auditory nerve activity

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 - 80 years ( inclusive borders)
• patient having to undergo surgery at the level of the ponto-cerebellar angle (microvascular decompression, vestibular neurotomy, tumor resection of the meningioma type or schwannoma) and
• Unaffected by neuro-sensory hearing loss, defined by mean auditory thresholds of less than 20 dB in tone audiometry in bone conduction on the side of the ear to be operated (N = 15, Group 1) or
• Showing mild to moderate hearing loss defined by average hearing loss (average of 500, 1000, 2000 and 4000 Hz thresholds) greater than 20 dB and less than 55 dB in air conduction threshold tone audiometry (N = 15 Group 2).
• Voluntary subjects to participate in the study,
• Subjects having signed written consent to participate in the study,
• Easily accessible topics.

Exclusion Criteria:

• Subjects unable to understand the nature and goals of the study and / or having difficulty communicating with the investigator,
• Subjects refusing to participate, subjects whose free and informed consent has not been sought, subjects for which a consent form has not been signed,
• Subjects for whom there is a contraindication to general anesthesia,
• Subjects with a central neurological pathology that can disrupt electrophysiological recordings
• Not affiliated to a French social security scheme or not benefiting from such a scheme,
• Majors protected by law,
• Pregnant women,
• deprived of liberty by judicial or administrative decision,
• Infectious or inflammatory pathology of the middle ear.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Subjects with no hearing loss; Subjects referred for cerebellopontine angle surgery with no hearing loss with recording of auditory nerve activity by contact electrode	Procedure: Recording of auditory nerve activity; near field recording of auditory nerve activity with contact electrode
EXPERIMENTAL: Subjects with hearing loss; Subjects referred for cerebellopontine angle surgery with hearing loss with recording of auditory nerve activity by contact electrode	Procedure: Recording of auditory nerve activity; near field recording of auditory nerve activity with contact electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amplitude of global evoked auditory nerve activity	36 months
Spectrum of global evoked auditory nerve activity	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mesure of peristimulus time responses of evoked auditory nerve activity	36 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Reims University hospital; Institute for Neurosciences of Montpellier U1051
• Investigators: Principal Investigator: Frédéric VENAIL, PU-PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2018
• Primary Completion (ACTUAL): June 26, 2021
• Study Completion (ACTUAL): June 26, 2021

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (ACTUAL): June 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Hearing Loss; Tinnitus; Evoked auditory nerve activity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 9890

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No