By acquiring functional MR images and brainstem evoked response audiometry (BERA) from the auditory nuclei in the human brainstem, we expect to observe neurofunctional differences between the subjects with unilateral hearing loss, and subjects with…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints are differences between response characteristics associated
with unilateral hearing loss and the presence of tinnitus. These differences
are quantified as differences between the tonotopic map of the auditory cortex
between the subject groups. Tonotopic maps are based on the MRI acquisitions.
Secondary outcome
A second study parameter is a difference in BERA peak amplitudes and latencies
between the groups.
Background summary
Ringing in the ear or tinnitus is a hearing disorder, defined as phantom sound
perception without any external sound source. The loudness of tinnitus is
different in different persons, and in severe cases, it can negatively affect
the person*s life.
Tinnitus probably originates from functional changes in the brain auditory
system. Animal experiments have reported such changes in the brainstem in
animals with induced tinnitus. There is also a strong hypothesis which links
tinnitus to hearing loss. Earlier studies suggest that there are differences in
the functional changes between unilateral and bilateral hearing loss, and that
these may lead to tinnitus via different pathways. The current study will test
functional differences between subjects with unilateral hearing loss, and
subjects with and without tinnitus.
We are going to investigate the human brain in a highly informative manner,
using a state-of-the-art zoom-fMRI. The measurement will be combined with
brainstem evoked response audiometry (BERA), the standard clinical tool to
assess the auditory response from the brainstem.
Study objective
By acquiring functional MR images and brainstem evoked response audiometry
(BERA) from the auditory nuclei in the human brainstem, we expect to observe
neurofunctional differences between the subjects with unilateral hearing loss,
and subjects with and without tinnitus.
Study design
This is an exploratory case-control study in which four groups of human
subjects are compared. This study design allows us to disentangle the
contributions that unilateral hearing loss and tinnitus have to functional
changes in the brain auditory pathway, respectively.
Study burden and risks
Each participant is asked to fill in a number of questionnaires regarding
handedness, MRI compatibility, and hyperacusis. Also, tinnitus patients fill in
questionnaires regarding their tinnitus. The questionnaire part takes 30
minutes in total. Then, using clinical audiometry, we measure the hearing
thresholds of the subject and perform a loudness matching task to determine
stimulus levels to be used in subsequent MRI sessions. The tinnitus pitch will
also be measured. This takes 50 minutes. The functional MRI session via a
3-Tesla MRI scanner takes 75 minutes. Also, the auditory brainstem response
measurement takes 40 minutes. None of the procedures has a known benefit or
risk for the participant.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, the subject
- must have in the age range of 18-80 years old.
- Audiogram: [35 dB =< (pure tone average in 2, 4, and 8 kHz) =< 65] for one
ear and audiogram [(pure tone average in 2, 4, and 8 kHz) < 30] for the other
ear, if the subject is in one of the unilateral hearing loss groups.
- Audiogram: [(pure tone average in 2, 4, and 8 kHz) < 30] for both ears, if
the subject is in one of the groups with no hearing loss.
- Audiogram: [(pure tone average in 0.25 0.5, and 1 kHz) < 30] for both ears,
for all the subjects
Exclusion criteria
- Non-conformance to any of the inclusion criteria.
- Contraindication for MRI according to the MRI checklist.
- Reported medical, neurological, or psychiatric disorders (excluding tinnitus
and hearing loss).
- Using hearing aids
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 | NL79002.042.21 |