Skip to main content
Clinical Trials/NL-OMON41097
NL-OMON41097
Withdrawn
Not Applicable

eural reorganization in tinnitus: a high-field functional and antomical MRI study - Neural reorganization in tinnitus

niversiteit Maastricht0 sites30 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
phantom sound perception
Sponsor
niversiteit Maastricht
Enrollment
30
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • The 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 Criteria

  • Exclusion 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

Outcomes

Primary Outcomes

Not specified

Similar Trials