The main objective of this study is to test the feasibility of using DTI in combination with tractography to visualize differences between a degenerated and normal auditory nerve.
ID
Source
Brief title
Condition
- Ear and labyrinthine disorders congenital
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the difference between the normal auditory
nerve and degenerated auditory nerve. The difference can be quantified with the
diffusion parameters fractional anisotropy (FA), apparent diffusion coefficient
(ADC), axial diffusivity (AD) and radial diffusivity (RD).
Secondary outcome
The secundary endpoint of the study is the comparison between the normal nerve
in SSD patients and the normal nerve in healthy controls.
Background summary
Profound sensorineural hearing loss, or deafness, is caused by loss of sensory
hair cells in the cochlea. Cochlear implantation has become a very successful
treatment option for patients with profound hearing impairment, often providing
a high degree of speech perception. A good condition of the auditory nerve is
of paramount importance for cochlear implantation. However, degeneration of the
auditory nerve occurs as a result of hair cell loss and the extent of
degeneration varies widely among 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 implantation. Structural magnetic
resonance imaging (MRI) is being used for the preoperative assessments, but the
conventional MR images are insufficient to estimate the condition of the
auditory nerve.
A new imaging technique, MR diffusion tensor imaging (DTI), can be used to
visualize peripheral nerves as the auditory nerve. The hypothesis is that it is
feasible to visualize differences between a degenerated nerve and a normal
auditory nerve.
Study objective
The main objective of this study is to test the feasibility of using DTI in
combination with tractography to visualize differences between a degenerated
and normal auditory nerve.
Study design
This is an observational study performed at the University Medical Center
Utrecht (UMCU). Patients with single-sided deafness (SSD) and healthy
volunteers will undergo DTI in combination with tractography. SSD patients are
ideal subjects to test our hypothesis as they are expected to have one healthy
and one degenerated nerve allowing within-subject comparisons.
Study burden and risks
The image session will take approximately 30 minutes with a DTI research scan
duration of 10 minutes. For SSD patients, this scan will be subsequent to the
clinical MRI-scan. The healthy controls will have to undergo tone audiometry of
approximately 30 minutes, followed by the MRI-DTI-scan of approximately 30
minutes.
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:
- Patients aged 18 or older.
- Normal function of middle ear (i.e. no acute middle ear infections or tympanic membrane perforations). Air bone gap (reflecting middle-ear function) <10 dB.;Additional inclusion criteria for normal hearing group:
- Hearing within normal range: hearing threshold for individual frequencies <= 20 dB HL; the average over 0.5,1,2 and 4 kHz <= 15 dB HL;Additional inclusion criteria for SSD group:
- Hearing in *deaf* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz) >= 70 dB HL.
- Hearing in *normal* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz) <= 30 dB HL. Note that near-normal hearing (not normal but no hearing aid needed) is included by applying a less stringent criterion than for the normal-hearing subjects.
Exclusion criteria
A potential 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. ossification).
- Disability which could interfere with the completion of the tests (i.e. psychiatric problems or severe co-morbidity with an expected survival of less than five years).
- Patients with contraindications for Magnetic Resonance Imaging (MRI)
- Not fulfilling the criteria of the MRI inclusion list (see file F), including the presence of any type of metal in the body, tattoos on the skin and pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45510.041.13 |