Firstly, comparison of DTI outcome variables between the auditory nerve of a deaf ear with that of a normal ear. Secondly, in patients who receive a CI, DTI measures will be compared to measures derived from electrically evoked compound action…
ID
Source
Brief title
Condition
- Ear and labyrinthine disorders congenital
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of fractional anisotropy (FA) and mean diffusivity (MD) of the
auditory nerve between normal and deaf sides Furthermore, FA and MD will be
correlated with duration of deafness. Other DTI metrics may be considered as
well.
Secondary outcome
Correlation between the DTI parameters and eCAP parameters of patients who
receive a CI. Correlation of DTI and eCAP parameters with duration of deafness.
Reproducibility of DTI measures.
Background summary
A cochlear implant (CI) can restore hearing in patients with profound
sensorineural hearing loss by direct electrical stimulation of the auditory
nerve. A good condition of the auditory nerve is of paramount importance to
bring about satisfactory hearing results after cochlear implantation. However,
degeneration of the auditory nerve occurs as a result of cochlear hair cell
loss and the extent of degeneration may vary between the two ears in
bilaterally deaf (BD) patients. In most cases, one ear is implanted. It is
therefore important to choose the ear with the best nerve, which presumably
will give the greatest benefit of a CI. In a recent pilot study in 10 subjects
(METC 13-493) we have demonstrated that diffusion tensor imaging (DTI), a
magnetic resonance imaging (MRI) technique, can be used to visualize the
auditory nerve (Vos et al. 2015). A quantified DTI measure showed differences
between unilaterally deaf (UD) patients and control subjects, but no
differences between the normal and deaf side within the UD patients.
Study objective
Firstly, comparison of DTI outcome variables between the auditory nerve of a
deaf ear with that of a normal ear. Secondly, in patients who receive a CI, DTI
measures will be compared to measures derived from electrically evoked compound
action potentials (eCAPs).
Study design
This is an observational study performed at the University Medical Center
Utrecht (UMCU). Patients with UD who will receive a CI and patients with BD who
will receive a CI, and healthy volunteers will undergo DTI. The UD and BD
patients will be subject to eCAP recordings directly after implantation.
Study burden and risks
The used techniques in this study are audiometry, MRI, and eCAP recording.
Normal-hearing subjects undergo 15 minutes audiometry. All patients and 10 of
the normal-hearing control subjects undergo an MRI scan of approximately 30
minutes. The remaining 10 control subjects will participate in 4 MRI sessions
of 30 minutes. In all patients a session of 15 minutes eCAP recordings will be
performed in addition to clinical eCAP recordings performed under anesthesia
immediately following CI surgery. The risks of these techniques are negligible,
and not different from when used a routine clinical setting. No immediate
benefits for individual subjects are to be expected from participation in this
study. However, the knowledge derived from this study could facilitate the
choice for the best ear to implant in patients with BD.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Aged 18 or older
- Normal function of middle ear, i.e., no acute middle ear infections, no tympanic membrane perforations and an air bone gap (which reflects middle-ear function) < 10 dB.;Additional inclusion criteria for unilateral deaf groups (same as in CINGLE trial):
- Hearing in *deaf* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz) >= 70 dB HL.
- *Deaf* ear has been deaf for no longer than 10 years
- Hearing in *normal* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz) <= 30 dB HL. Note that near-normal hearing is included by applying a less stringent criterion than for the normal-hearing subjects.;Additional inclusion criteria for bilateral deaf group:
- Admitted by cochlear implant team of the UMCU for cochlear implantation based on various clinical criteria.
-Implanted with a CI from manufacturer MED-EL or Cochlear;Additional inclusion criteria for normal-hearing group:
- Hearing within normal range: hearing threshold for individual frequencies <= 25 dB HL
- Average hearing threshold over 0.5,1,2 and 4 kHz <= 15 dB HL.
Exclusion criteria
A subject who meets any of the following criteria will be excluded from participation in this study:
- Abnormal cochlear anatomy in one or both ears (i.e. malformation or ossification).
- Disability which could interfere with the completion of the tests (i.e. psychiatric problems).
- Patients with contraindications for Magnetic Resonance Imaging (MRI) - not fulfilling the criteria of the MRI inclusion list, including the presence of a pacemaker and pregnancy
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL53077.041.15 |