The current study employs functional magnetic resonance imaging (fMRI) to investigate the auditory and limbic areas in tinnitus patients by means of innovative analysis methods that permit the assessment of functional interactions between brain…
ID
Source
Brief title
Condition
- Hearing disorders
- Neurological disorders NEC
- Disturbances in thinking and perception
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Audiometric and psychometric values obtained in a diagnostic protocol, and
stimulus-evoked as well as spontaneous BOLD fMRI signals in the brain.
Secondary outcome
not applicable
Background summary
Tinnitus is a prevalent hearing disorder that affects millions of people and
has a severely disabling impact on life in about 1-3% of the general
population. It is characterized by the perception of sound in the absence of
any external sound sources. An increasing amount of evidence suggests that
tinnitus is generated as a result of pathological spontaneous activity in the
brain. In addition to auditory brain regions, the limbic system that processes
emotions is thought to be involved in the underlying mechanism. Neuroimaging
studies on tinnitus have so far mainly focused on sound-evoked responses in the
classical auditory brain centers only. They have neither investigated
spontaneous fluctuations in brain activity, nor addressed the functional
relationships with other brain areas like the limbic system.
Study objective
The current study employs functional magnetic resonance imaging (fMRI) to
investigate the auditory and limbic areas in tinnitus patients by means of
innovative analysis methods that permit the assessment of functional
interactions between brain areas. Because these methods do not rely on the
presentation of external sound stimuli and are able to study inherent
spontaneous activity of the brain, they offer a unique opportunity in the
context of a disorder like tinnitus, in which a phantom sound percept is
generated intrinsically. The study will include tinnitus subjects and matched
controls. Functional MRI experiments will be performed using novel paradigms
that include the presentation of a variety of sound stimuli as well as
so-called resting state measurements. The analysis of the fMRI data will focus
on the primary hypothesis that the interaction between the limbic and the
auditory system is abnormal in tinnitus patients. The outcome of this study is
expected to be of key importance to our understanding of tinnitus.
Study design
Two-group exploratory study.
Study burden and risks
The clinical diagnostic tests involve ENT-investigation, several audiometric
tests, and the administration of questionnaires (~4 hours.). A single fMRI
scanning session will take place on a separate day (~2 hours). None of the
procedures expose the subject to known risks.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
No reported tinnitus (control group) / Mild to moderate subjective tinnitus with THI-score of 18-56 (patient group)
Adult (18-60 yrs.)
No medical, neurological, or psychiatric disorders (excluding tinnitus)
Normal hearing to moderate symmetrical hearing loss (<60 dB at 500-2000Hz)
No contraindications for fMRI
Exclusion criteria
Non-compliance with inclusion criteria
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 | Nederlandse Onderzoek Databank nummer OND1331679 |
| CCMO | NL27590.042.09 |