Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06434129 |
| Other study ID # |
1a |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
January 1, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Assiut University |
| Contact |
Mahmoud Aly, Master |
| Phone |
00201011367958 |
| Email |
am.8892[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
DTI and auditory tractography can be incorporated into the diagnostic toolkit for patients
who are scheduled to undergo cochlear implantation and whose standard assessments have been
unable to determine the functional integrity of the auditory pathway. These techniques aid in
decision-making processes regarding potential outcomes, determining the optimal side for
implantation, providing counseling regarding the possibility of limited benefits from
surgery, and considering alternative forms of rehabilitation. The investigators including
patients with varying degrees of hearing loss, as well as patients with normal radiological
findings who are scheduled for cochlear implantation. The ultimate goal is to create a
comprehensive map across the entire hearing spectrum and validate the findings of this
study..
Description:
Hearing is a complex process in which many parts of the ear contribute to transmit signals to
the brain. The auditory system consists of both peripheral structures (external, middle, and
inner ear)as well as central regions (cochlear nuclei in the medulla oblongata, superior
olivary nuclei and lateral lemniscus in the pons, inferior colliculus in the midbrain, medial
geniculate nuclei in the thalamus, and auditory cortex in the superior temporal Heschl
gyrus). Most of auditory fibres undergo a contralateral decussation to the opposite superior
olive in the region known as the trapezoid body.
The broad term "sensorineural hearing loss" (SNHL) It accounts for a substantial proportion
of hearing impairment cases globally, affecting individuals of various age groups. It has
been used by clinicians to refer to either malfunctioning inner ear or a retrocochlear
problem affecting the canalicular vestibule-chochlear (VIII) cranial nerve and
cerebellopontine angle or that involves the higher (central) auditory nuclei and neural
tracts. Identifying the etiology of hearing loss is valuable to establish a treatment
strategy that can help to prevent or slow down complete loss of auditory function.
The central auditory structures are involved in various processes that may occur in isolation
from those involving peripheral receptors .SNHL can be a consequence of different conditions,
including viral infection, tumor, ischemia, multiple sclerosis, or congenital malformations.
Despite continuous efforts to delineate the pathophysiological attributes of SNHL, the
aetiology remains mostly unclear with nearly 90% of cases being idiopathic. Therefore,
finding a method to accurately predict microstructural changes of the auditory circuit is
extremely important.
Conventional imaging modalities, including computed tomography (CT) and magnetic resonance
imaging (MRI), have offered invaluable insights into the macroscopic changes associated with
SNHL, such as cochlear morphology and structural abnormalities. However, these techniques
lack the sensitivity to discern subtle alterations occurring at the microstructural level,
impeding a comprehensive understanding of the underlying pathophysiological processes.
DTI-MRI's ability to capture subtle changes in tissue microstructure makes it an ideal
candidate for probing the intricate auditory pathways affected by SNHL. By quantifying the
diffusion of water molecules along axonal pathways, DTI-MRI can uncover alterations in the
integrity of auditory neural connections, which are often missed by conventional imaging
methods. Furthermore, DTI-derived metrics, such as fractional anisotropy (FA), axial
diffusivity (AD), radial diffusivity (RD), and mean diffusivity (MD), offer quantitative
measures to characterize the white matter integrity and myelination in auditory pathways.
