Primary objective of the study: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 the AEP response in EEG recordings.Secundary objectives of the study:1. To…
ID
Source
Brief title
Condition
- Aural disorders NEC
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary EEG study parameters are the latency (in miliseconds) and amplitude
(in microvolts) of the N100 component of the AEP response. The study parameters
will be compared between the three study groups.
Secondary outcome
The secundary study parameters are the latency (in miliseconds) and amplitude
(in microvolts) of the N200 and P300 components of the AEP response in the EEG
recordings. The frequency spectrum of the brain activity is also a study
parameter. The study parameters will be compared between the three study
groups.
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 in about 1% of the population the tinnitus strongly affects their
life. 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 in what brain regions the tinnitus is generated and what the activity
in those regions is. However, the pathophysiology of tinnitus is still greatly
unknown. Therefore, in this study the activity in brain areas that are
suspected to generate the tinnitus sound will be visualized with EEG. The focus
with the EEG measurements will be on the auditory cortex.
Study objective
Primary objective of the study:
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 the
AEP response in EEG recordings.
Secundary objectives of the study:
1. To find out if there are changes in the parameters of the AEP components in
the EEG recordings in tinnitus patients.
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 two questionnaires which will take
about 15 minutes. Furthermore they are asked to travel to the Clinical
Neurophysiology department of the Medisch Spectrum Twente once. There they will
undergo an EEG scan with a duration of about 25 minutes. The total duration of
the study for each participating subject will be 1 hour (including preparation
time). 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 woman;
Tinnitus patients:
- Tinnitus perception for more than 1 year
- Perception of a tone
- Unchanged tinnitus perception (pitch, amplitude) for more than 6 months
Hearing impaired non-tinnitus subjects:
- Perceptive hearing impairment
Exclusion criteria
General:
- Age < 18 years
- 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) Menière's disease
- (history of) tinnitus perception
Hearing impaired non-tinnitus:
- Conductive hearing impairment
- (history of) Menière's 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 |
---|---|
Other | Wordt gedaan na goedkeuring van METC Twente |
CCMO | NL35949.044.11 |