The primary goal of this study is to evaluate the effect of varying stimulation parameters (inter-phase gap, phase duration, en inter-pulse interval) on the nerve and brainstem response and to correlate this to speech perception performance with the…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of varying stimulation parameters (IPG, PD, and IPI) on the
characteristics of the nerve and brainstem response and the correlation of that
effect with speech perception performance.
Secondary outcome
The correlation between speech perception and tone decay.
The correlation between nerve and brainstem responses and tone decay.
Background summary
Presently, cochlear implantation is the only successful treatment available for
the deaf or profoundly hearing impaired. A persistent problem is the large
variation in speech perception performance between patients after implantation.
One of the explanations could be that the auditory nerve, consisting of spiral
ganglion cells (SGCs), degenerates due to the duration of inactivity, as a
result of which the implant cannot function as well. If we want to investigate
this, we have to find a way to measure the viability of the auditory nerve.
Neither histology nor imaging techniques are an option.
Recent research from our lab on implanted deafened guinea pigs showed a
correlation between the number and size of the SGCs and the change in response
of the auditory nerve to varying stimulation paradigms. We would like to
translate these findings to a human CI population. If we can find a correlation
between the response of the nerve and speech perception performance, we will
have a prognostic factor with which the expectations of the patient can be
managed. In addition, tone decay measurements might vary between CI patients
with good or poor speech perception. A recent pilot study (13-648) showed this
possibility and we would like to investigate this further.
Study objective
The primary goal of this study is to evaluate the effect of varying stimulation
parameters (inter-phase gap, phase duration, en inter-pulse interval) on the
nerve and brainstem response and to correlate this to speech perception
performance with the CI. The secondary goal is to determine if tone decay can
differentiate between CI patients with good or poor speech perception.
Study design
This is a pilot study with a prospective cross-sectional design, performed at
the UMC Utrecht.
Study burden and risks
The risk of the electrophysiological and tone decay measurements is considered
to be neglegible. Current levels are not higher than the safety limits that are
used daily in the clinic and not higher than the maximal comfortable listening
levels of the subject. The expected burden due to participation for the
subjects consists two sessions of around 3 hours (and two sessions of 10
minutes and half an hour for one of the groups). Physical discomfort is
comparable to what CI patients endure during routine clinical checks. Subjects
will not have a direct benefit of this study. The results of this study will
contribute to managing the expectations of patients and ensure a more personal
fitting of the implant.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years.
• Capable to provide informed consent.
• Dutch as native language.
• Suffering from bilateral deafness for which a cochlear implant (CI) is the best suitable treatment as decided by the CI-team of the UMC Utrecht.
• The chosen type of CI must be supported by the available test equipment.
Exclusion criteria
• Neurological or mental disorders.
• Use of anticonvulsant medication or psychotherapeutic drugs.
• No measurable eCAPs on any of the available electrodes.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51970.041.15 |
| OMON | NL-OMON24268 |