Using Electrocochleography During Cochlear Implantation of the Neuro Zti.

NCT04651660 | Withdrawn

• 1 other identifier: PIC-22
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications. First, a novel technique for placing and maintaining the probe in place during the whole insertion will be used. Second, a new metric for estimating the eCochG response will be evaluated (eCochG trauma index). The secondary objective is to find other markers of the cochlear trauma insertion associated to eCochG measures. This will be used to evaluate to which extend a traumatic insertion will be deleterious for the patient's post-operative hearing, and ultimately to prevent trauma to the inner ear. Finally, the potential differences in cochlear trauma resulting of the electrode array insertion from two different surgery techniques will be investigated; Either using a manual insertion or using a robotic arm that will drive the insertion automatically.

Conditions

Cochlear Hearing Loss; Cochlear Trauma

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between the eCochG trauma index (in µV) and the residual hearing (in dB HL).

  The eCochG trauma index correspond to electrophysiological changes of the cochlear response during the CI electrode insertion, and is calculated from the difference between post-insertion and pre-insertion eCochG measure (in µV). The hearing loss is calculated from the difference between the post-surgical and pre-surgical hearing thresholds (in dB HL). The correspondence is calculated from the correlation coefficient between the eCochG trauma index and the hearing loss. It is expected that a potential damage measured by the eCochG during the surgery have affected auditory threshold.

  Through study completion, an average of 2 years

Secondary Outcomes (6)

• Significant decrease of eCochG trauma index (in µV) for electrode array insertion performed manually compared to robotic.

  Through study completion, average of 2 years

• Correlation coefficient between the eCochG trauma index (in µV) and a misplacement of the electrode array inside the cochlea based on CT scan.

  Through study completion, average of 2 years

• Correlation coefficient between the eCochG trauma index (in nV) with the electrical charges (in nC) required to elicit eCAP threshold.

  Through study completion, average of 2 years

• Correlation coefficient between the eCochG trauma index (in nV) with impedance measurement (in Ω).

  Through study completion, average of 2 years

• Correlation coefficient between the eCochG trauma index (in nV) with fitting map electrical charges (in nC), and slopes of their growth functions.

  Through study completion, average of 2 years

Study Arms (2)

Manual Insertion

EXPERIMENTAL

The surgeon will follow a classical surgical procedure for the cochlear implantation, i.e. mastoidectomy to access the temporal bone, posterior tympanotomy to access the cochlea and round window (RW) approach for the CI electrode array insertion. Before opening the RW, the eCochG recording electrode is placed on the cochlear promontory, and placed not to obstruct the surgery. The probe is thus maintained during the whole MANUAL insertion (by the surgeon).

Device: Neuro Cochlear Implant System

Robotic insertion

EXPERIMENTAL

The surgeon will follow a classical surgical procedure for the cochlear implantation, i.e. mastoidectomy to access the temporal bone, posterior tympanotomy to access the cochlea and round window (RW) approach for the CI electrode array insertion. Before opening the RW, the eCochG recording electrode is placed on the cochlear promontory, and placed not to obstruct the surgery. The probe is thus maintained during the whole ROBOTIC insertion.

Device: Neuro Cochlear Implant System

Interventions

Neuro Cochlear Implant System DEVICE

Before the mastoidectomy, the ear canal is cleaned, the insert earphone is connected to the Eclipse (Oticon Medical software) preamplifier and placed into the ear canal. The EEG scalp electrodes (active, ground electrode) are placed on the patient's head. After the posterior tympanotomy, the reference electrode (eCochG probe) is placed on the cochlear promontory. The CI electrode array will be inserted following one of the two possible techniques while the eCochG will be recording. The surgeon will either manually insert the array using the Oticon Medical stylet and following the surgery guides and recommendations from Oticon Medical or will control the Robotol insertion angle and drive the robotic arm in the same way.

Manual Insertion; Robotic insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> or equal 18 years ;
• Candidate for Neuro Zti EVO cochlear implant system, unilateral or bilateral recipient ;
• Preoperative residual hearing with audiometric thresholds less or equal than 80 dB at 500 Hz, or higher frequencies

You may not qualify if:

• Medical or psychological conditions which contraindicate surgery (e.g middle ear infection, tympanic membrane perforation) ;
• Patient with a psychological or linguistic inability to understand the information sheet ;
• Patient under legal protection or deprived of liberty
• Patient included and participating to another trial.

Sponsors & Collaborators

• Oticon Medical: lead

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yann YN Nguyen

  Hôpital Pitié-Salpêtrière (Paris)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 3, 2020
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share