search
Back to results

Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE (PULSE)

Primary Purpose

Sensorineural Hearing Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cochlear implant (Oticon) stimulation parameter optimization
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sensorineural Hearing Loss focused on measuring hearing loss, cochlear implant, psychoacoustic, charge integration efficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: post-lingually deaf adults with at least one year of cochlear implant experience unilateral and bilateral cochlear implant recipients Oticon device with Neuro Zti array Patient affiliated to french social security Consent signed Exclusion Criteria: Patients under court protection, guardianship or curatorship

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cochlear implant users with Neuro Zti array

    Arm Description

    Post-lingually cochlear implant users with 12 months of auditory experience Modifications of pulse parameters to determine the charge integration efficiency which is related with neuron survival population

    Outcomes

    Primary Outcome Measures

    Calculate the charge integration efficiency along the electrodes
    Charge integration efficiency will be determined for each electrode by noting the minimum and maximum loudness perceived by the patient as function of pulse phase duration and amplitude

    Secondary Outcome Measures

    Questionnaire between Intensity discrimination and charge integration efficiency
    3 electrodes that span the range of charge integration efficiency values will be selected as test electrodes. Three intensities will be presented to the patient through the implant and it will be asked to the patient to determine which intensity is higher than the others.

    Full Information

    First Posted
    July 27, 2023
    Last Updated
    August 25, 2023
    Sponsor
    University Hospital, Tours
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06013215
    Brief Title
    Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE
    Acronym
    PULSE
    Official Title
    PULSE - Paramètres de l'Impulsion électrique et Population Neuronale Chez le Patient implanté cochléaire - Etude en Ouvert, Non contrôlé, Non randomisée
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2025 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Tours

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.
    Detailed Description
    The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. Currently, the intensity perceived by the patient is coded by the duration and the amplitude of the electrical impulse but companies have different approaches and fix one of the two parameters for the setting of the processors. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sensorineural Hearing Loss
    Keywords
    hearing loss, cochlear implant, psychoacoustic, charge integration efficiency

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cochlear implant users with Neuro Zti array
    Arm Type
    Experimental
    Arm Description
    Post-lingually cochlear implant users with 12 months of auditory experience Modifications of pulse parameters to determine the charge integration efficiency which is related with neuron survival population
    Intervention Type
    Other
    Intervention Name(s)
    Cochlear implant (Oticon) stimulation parameter optimization
    Intervention Description
    The pulse amplitude and/or the pulse phase duration will be optimize to improve the intensity resolution of the cochlear implant which may benefit speech perception
    Primary Outcome Measure Information:
    Title
    Calculate the charge integration efficiency along the electrodes
    Description
    Charge integration efficiency will be determined for each electrode by noting the minimum and maximum loudness perceived by the patient as function of pulse phase duration and amplitude
    Time Frame
    4 hours
    Secondary Outcome Measure Information:
    Title
    Questionnaire between Intensity discrimination and charge integration efficiency
    Description
    3 electrodes that span the range of charge integration efficiency values will be selected as test electrodes. Three intensities will be presented to the patient through the implant and it will be asked to the patient to determine which intensity is higher than the others.
    Time Frame
    4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: post-lingually deaf adults with at least one year of cochlear implant experience unilateral and bilateral cochlear implant recipients Oticon device with Neuro Zti array Patient affiliated to french social security Consent signed Exclusion Criteria: Patients under court protection, guardianship or curatorship
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Bakhos, MD, PhD
    Phone
    +33 (0)218370523
    Email
    bakhos.david@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elodie MOUSSET, MSc
    Phone
    +33 (0)247474665
    Email
    E.MOUSSET@chu-tours.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Bakhos
    Organizational Affiliation
    University Hospital, Tours
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE

    We'll reach out to this number within 24 hrs