fMRI and Brainstem Evoked Response Audiometry (BERA) to Probe the Mechanism of Human Brain Auditory System in Tinnitus and Unilateral Hearing Loss

fMRI and Brainstem Evoked Response Audiometry (BERA) to Probe the Mechanism of Human Brain Auditory System in Tinnitus and Unilateral Hearing Loss - fMRI and BERA for tinnitus and unilateral hearing loss

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52331

Enrollment

Registered

2022-02-07

Start date

2022-02-08

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ringing in the ear

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, the subject - must have in the age range of 18-80 years old. - Audiogram: [35 dB =

Exclusion criteria

Exclusion criteria: - Non-conformance to any of the inclusion criteria. - Contraindication for MRI according to the MRI checklist. - Reported medical, neurological, or psychiatric disorders (excluding tinnitus and hearing loss). - Using hearing aids

Design outcomes

Secondary

Measure	Time frame
A second study parameter is a difference in BERA peak amplitudes and latencies between the groups.	—

Primary

Measure	Time frame
The main endpoints are differences between response characteristics associated with unilateral hearing loss and the presence of tinnitus. These differences are quantified as differences between the tonotopic map of the auditory cortex between the subject groups. Tonotopic maps are based on the MRI acquisitions.	—

Countries

Netherlands

Outcome results