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Neural reorganization in tinnitus: a high-field fMRI study


- candidate number19329
- NTR NumberNTR4752
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-aug-2014
- Secondary IDsABR concept 49812 METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
- Public TitleNeural reorganization in tinnitus: a high-field fMRI study
- Scientific TitleNeural reorganization in tinnitus: a high-field fMRI study
- ACRONYMNeural reorganization in tinnitus
- hypothesis
- Healt Condition(s) or Problem(s) studiedTinnitus, fMRI
- Inclusion criteriaThe main inclusion criteria of the patient groups are:
• Male or female between 18 and 75 years
• Subjective tinnitus (i.e. not caused by an acoustic source inside the head, e.g., vascular abnormalities that cause pulsatile tinnitus)
• Stable tinnitus (i.e., present for at least 8 h per day since more than a year)
• Tinnitus that is dominant within one of three octaves (low: <750 Hz, middle: 750-3000 Hz, high: >3000 Hz; the exact frequency ranges will be determined empirically based on patient availability)
• Patient has not received medical care from an otolaryngologist and is able and willing to undergo the MRI measurements, as indicated by written informed consent.
The main inclusion criteria of the healthy subjects are:
• Male or female between 18 and 75 years
• No tinnitus
• Subject is able and willing to undergo the MRI measurements, as indicated by written informed consent.
- Exclusion criteriaExclusion criteria of the patient groups are:
• Fletcher Index > 50 dB HL for both ears (i.e., mean of hearing loss in decibels for 1k, 2k and 4k Hz)
• Hyperacusis (oversensitivity to sound), phonophobia (defined as a persistent, abnormal, and unwarranted fear of sound), misophonia (dislike of certain sound),
• Neurological-, neurosurgical- and psychiatric history
• Use of dopaminergic drugs since this medication greatly influence the fMRI scans (Haslinger et al., 2001, Mattay et al., 2002)
• Morbid obesitas (BMI > 35) since it cannot be guaranteed that these subjects will fit in the scanner
• Current treatment of tinnitus and implanted devices or other metal objects that are not suitable for MRI.

Exclusion criteria of the healthy subjects are:
• Fletcher Index > 50 dB HL for both ears (i.e. mean of hearing loss in decibels for 1k, 2k and 4k Hz)
• Hyperacusis (oversensitivity to sound), phonophobia (defined as a persistent, abnormal, and unwarranted fear of sound), misophonia (dislike of certain sound),
• Neurological-, neurosurgical- and psychiatric history
• Use of dopaminergic drugs since this medication greatly influence the fMRI scans (Haslinger et al., 2001, Mattay et al., 2002)
• Morbid obesitas (BMI > 35) since it cannot be guaranteed that these subjects will fit in the scanner
• Current treatment of tinnitus and implanted devices or other metal objects that are not suitable for MRI.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-sep-2014
- planned closingdate1-mei-2015
- Target number of participants26
- InterventionsIn a first session, at the otorinolaryngologie department, a hearing test will be combined with matching of the tinnitus (subjective loudness and pitch). In the second session, at Scannexus, the patients will be asked to take place in the MRI scanner. Patients will be asked to lay as still as possible and to react (with a button press) when hearing specific sounds. The total scanning time is approximately 55 minutes.
- Primary outcomeThe link between frequency tuning and tinnitus will be tested by comparing the size and response magnitude of the auditory cortex regions that show tuning to the patient’s specific tinnitus frequency vs. regions that show tuning to the other (non-tinnitus) frequencies. In this way, patients can serve as their own controls, in addition to matching healthy controls.
- Secondary outcomeFurthermore, anatomical features (measures of myelin content and cortical thickness) will be assessed in the same regions of interest as mentioned in the primary outcome.
- TimepointsAfter the fMRI scan (2nd meeting), the study ends.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES L. Riecke
- CONTACT for SCIENTIFIC QUERIES L. Riecke
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
NWO, Universiteitsfonds Limburg (SWOL), Maastricht University
- Publications
- Brief summaryThe general goal of our study is to unravel the anatomical and functional correlates of tinnitus in the human brain using structural and functional magnetic resonance imaging (MRI). We will use a high-field (7 T) MRI scanner and obtain a) detailed information about brain anatomy in the central auditory system and b) measure functional responses in the auditory cortex in order to assess the overall activation level and the tonotopic organization of auditory cortex.
- Main changes (audit trail)
- RECORD20-aug-2014 - 19-sep-2014


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