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Assessment of the condition of the auditory nerve by diffusion tensor imaging: A pilot study

Assessment of the condition of the auditory nerve by diffusion tensor imaging: A pilot study - Diffusion tensor imaging of the auditory nerve

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38438
Enrollment
10
Registered
2013-11-12
Start date
2014-01-10
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

hearing impairment single-sided deafness

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients aged 18 or older. - Normal function of middle ear (i.e. no acute middle ear infections or tympanic membrane perforations). Air bone gap (reflecting middle-ear function) = 70 dB HL. - Hearing in *normal* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz)

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Abnormal cochlear anatomy in one or both ears (i.e. ossification). - Disability which could interfere with the completion of the tests (i.e. psychiatric problems or severe co-morbidity with an expected survival of less than five years). - Patients with contraindications for Magnetic Resonance Imaging (MRI) - Not fulfilling the criteria of the MRI inclusion list (see file F), including the presence of any type of metal in the body, tattoos on the skin and pregnancy.

Design outcomes

Primary

MeasureTime frame
The main endpoint of this study is the difference between the normal auditory nerve and degenerated auditory nerve. The difference can be quantified with the diffusion parameters fractional anisotropy (FA), apparent diffusion coefficient (ADC), axial diffusivity (AD) and radial diffusivity (RD).

Secondary

MeasureTime frame
The secundary endpoint of the study is the comparison between the normal nerve in SSD patients and the normal nerve in healthy controls.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)