Primary: To find out which areas in the brain play a part in the maintenance of tinnitus, and what the roles of those areas are. This will be done using BOLD response fMRI imaging.Secondary: 1. To find out which areas in the brain play a part in the…
ID
Source
Brief title
Condition
- Aural disorders NEC
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main fMRI study parameter is the number of active voxels in the auditory
cortex and the inferior colliculus. The amount of active voxels is a measure
for the amount of activation caused by the application of the stimuli. The
number of voxels is determined by comparing both tinnitus matching and
non-matching stimuli to the silence.
Secondary outcome
A secondary fMRI study parameter is the number of active voxels in other areas
of the brain. The AC and IC are the most important, but not the only neural
correlates of tinnitus. Activity found in other regions of the brain is also
taken into account for further analysis.
Background summary
Tinnitus is often defined as the perception of a tone without the presence of
an external stimulus. About 10% of the Western adult population suffers from
tinnitus and with about 1% of the population the tinnitus seriously interferes
with the patients* lifes. Neuromodulation is a promising treatment for
tinnitus, but is not used in the Netherlands so far. In order for
neuromodulation to be successful it should be clear where in the brain the
neural correlates of tinnitus are. However, the pathophysiology of tinnitus is
still greatly unknown. Therefore in this study the brain areas that are
suspected to be neural correlates of tinnitus will be visualized with fMRI. The
focus with the fMRI measurements will be on the auditory cortex and the
inferior colliculus.
Study objective
Primary:
To find out which areas in the brain play a part in the maintenance of
tinnitus, and what the roles of those areas are. This will be done using BOLD
response fMRI imaging.
Secondary:
1. To find out which areas in the brain play a part in the development of
tinnitus.
2. To assess the theoretical potential of neuromodulation as a therapy for
tinnitus.
Study design
This is a case-control observational study comparing processing of sound in
tinnitus patients with normal hearing subjects and with hearing impaired
non-tinnitus subjects.
Study burden and risks
Participating subjects are asked to fill out three questionnaires which will
take approximately 15 minutes. Furthermore they are asked to travel to the FC
Donders Institute (Nijmegen) once. There they will undergo a combined fMRI scan
with a duration of about 1 hour. So the individual study duration will be 1,5
hours. There is no individual benefit for the subjects participating in the
study. There are no risks associated with the study, nor are there any harmful
aspects with respect to participating.
Postbus 50000
7500 KA Enschede
NL
Postbus 50000
7500 KA Enschede
NL
Listed location countries
Age
Inclusion criteria
General:
- Men and women;
Tinnitus patients:
- Unilateral tinnitus;
- Perception of a tone;
- Tinnitus perception for more than 1 year;
- Unchanged tinnitus perception (pitch, amplitude, side) for more than 6 months.
Hearing impaired non-tinnitus:
- Perceptive hearing impairment
Exclusion criteria
General:
- Age < 18 years;
- MRI contraindications;
- Claustrophobia;
- Ear inflammation;
- Other ear diseases like acoustic neuroma;
- Diagnosed neurological or psychiatric disease;
- Conductive hearing impairment.
Tinnitus patients:
- Perception of noise;
- Pulsatile tinnitus.
Normal hearing subjects:
- Conductive hearing impairment;
- Use of hearing aids;
- (history of) Menières disease;
- (history of) tinnitus perception.
Hearing impaired non-tinnitus:
- Conductive hearing impairment;
- (history of) Menières disease;
- (history of) tinnitus perception.
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 | NL32562.091.10 |