Electric Pace-pitched Hearing Achieves Natural Tonotopy

NCT ID: NCT03892941

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2021-03-18

Brief Summary

In search of the best possible outcome for the severe hearing impaired who have regained the ability to hear by means of a cochlear implant (CI), electrical stimulation and the information it carries should match as closely as possible to what the human brain naturally has evolved to cope with and learned to process instead of relying on plasticity to adapt to an induced mismatch. At the moment, however, CI's are fitted with a 'one size fits all' principle. This is known to cause a mismatch between the frequencies presented by the CI electrode array and the frequencies represented at the corresponding natural acoustic location in an individual cochlea. In this study it is hypothesized that an individual imaged based fitting that pursues natural hearing alignment and is implemented from the start of the rehabilitation process, will improve the individual outcomes of electric hearing. The natural fitting strategy is thought to give rise to a steeper learning curve, result in a better performance in challenging listening situations, improve sound quality, complement better with residual acoustic hearing in the contralateral ear and win the preference of CI-recipients.

Conditions

Deafness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Imaged based fitting

Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.

Group Type: EXPERIMENTAL

Imaged based fitting

Intervention Type: DEVICE

Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.

Clinical routine

Mapping of the electrical input of the cochlear implant will be based on a one-size-fits-all, as is part of clinical routine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Imaged based fitting

Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult (18y or older) and meeting the conventional Dutch CI criteria;
• Proficient speaker of Dutch language;
• Post-lingual onset of profound deafness (> 4 years of age);
• Subject receives an Advanced Bionics implant with Midscala electrode and an Advanced Bionics sound processor;
• Prepared to use study specific hearing aid (Phonak) for the duration of the study;
• Rehabilitation at MUMC+ for the first year after surgery regarding CI as well as HA;
• Active participation in trial related procedures such as daily randomization and regular testing.

Exclusion Criteria

• Physical or non-physical contraindications for MRI or CT imaging;
• Additional disabilities that may prevent active participation and testing as per protocol. If there are indications that the mental abilities to comply with the study procedures are insufficient, additional screening will be performed with the Mini-Mental State Examination. Patients will be excluded from the study when the resulting score is lower than 24;
• Cochlear or neural abnormalities that could affect outcome measures and/or compromise the placement of the electrode as assessed by the CI surgeon;
• Active participation in another prospective clinical trial;
• Pregnancy at time of imaging;
• Requirement for electric-acoustic activation prior to the first year follow-up;
• Having received a cochlear implant earlier (e.g. explantation or bilateral implantation).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erwin George, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC+

Locations

MUMC

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Lars Lambriks, Drs.

Role: CONTACT

lars.lambriks@mumc.nl

0636166071

References

Lambriks LJG, van Hoof M, Debruyne JA, Janssen M, Chalupper J, van der Heijden KA, Hof JR, Hellingman CA, George ELJ, Devocht EMJ. Evaluating hearing performance with cochlear implants within the same patient using daily randomization and imaging-based fitting - The ELEPHANT study. Trials. 2020 Jun 23;21(1):564. doi: 10.1186/s13063-020-04469-x.

Reference Type: DERIVED

PMID: 32576247 (View on PubMed)

Other Identifiers

NL64874.068.18

Identifier Type: -

Identifier Source: org_study_id