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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date January 1, 2026
Est. primary completion date October 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with audiometrically proven SNHL Exclusion Criteria: - Neurologically or psychiatric conditions affecting patient stability during MRI examination. - Cochlear implants. - Contraindications for MRI.

Study Design


Intervention

Diagnostic Test:
DTI
Diffusion MRI imaging

Locations

Country Name City State
Egypt Faculty of Medicine of Assuit Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of role of DTI in SNHL Assess the integrity of auditory pathway via measuring DTI metrics ( Fractional anisotropy and mean diffusivity) one year
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