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

PULSE - Paramètres de l'Impulsion électrique et Population Neuronale Chez le Patient implanté cochléaire - Etude en Ouvert, Non contrôlé, Non randomisée

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06013215
Acronym
PULSE
Enrollment
15
Registered
2023-08-28
Start date
2023-11-01
Completion date
2025-11-01
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural Hearing Loss

Keywords

hearing loss, cochlear implant, psychoacoustic, charge integration efficiency

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.

Interventions

OTHERCochlear implant (Oticon) stimulation parameter optimization

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

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Calculate the charge integration efficiency along the electrodes4 hoursCharge 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

MeasureTime frameDescription
Questionnaire between Intensity discrimination and charge integration efficiency4 hours3 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.

Contacts

Primary ContactDavid Bakhos, MD, PhD
bakhos.david@gmail.com+33 (0)218370523
Backup ContactElodie MOUSSET, MSc
E.MOUSSET@chu-tours.fr+33 (0)247474665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026