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

Sensorineural Hearing Loss Clinical Trial

— PULSE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06013215
• Other study ID #: DR230050-PULSE
• Secondary ID: 2023-A00476-39DR
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Tours
• Contact: David Bakhos, MD, PhD
• Phone: +33 (0)218370523
• Email: bakhos.david[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Other:
• Cochlear 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 hours