Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE
PULSE
PULSE - Paramètres de l'Impulsion électrique et Population Neuronale Chez le Patient implanté cochléaire - Etude en Ouvert, Non contrôlé, Non randomisée
3 other identifiers
interventional
15
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedAugust 28, 2023
August 1, 2023
2 years
July 27, 2023
August 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
4 hours
Secondary Outcomes (1)
Questionnaire between Intensity discrimination and charge integration efficiency
4 hours
Study Arms (1)
Cochlear implant users with Neuro Zti array
EXPERIMENTALPost-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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients under court protection, guardianship or curatorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Bakhos
University Hospital, Tours
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2023
First Posted
August 28, 2023
Study Start
November 1, 2023
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
August 28, 2023
Record last verified: 2023-08