Role of Diffusion Tensor-magnetic Resonance Imaging in Investigating Sensorineural Hearing Loss

May 23, 2024 updated by: Mahmoud Mohammad Aly, Assiut University
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..

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Faculty of Medicine of Assuit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Assiut university hospital patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
cases with SNHL
Diagnostic test: DTI
Diffusion MRI imaging
Controls
Normal people
Diagnostic test: DTI
Diffusion MRI imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of role of DTI in SNHL
Time Frame: one year
Assess the integrity of auditory pathway via measuring DTI metrics ( Fractional anisotropy and mean diffusivity)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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