- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07748819
DTI & DIR in Optic Neuritis (DTI & DIR)
MRI Evaluation of Optic Neuritis : Integrating Double Inversion Recovery and Diffusion Tensor Imaging .
Study Overview
Detailed Description
Optic neuritis is an inflammatory demyelinating disorder of the optic nerve that commonly presents with acute visual loss , which can result from a range of causes, making the correct diagnosis and prognosis of distinct conditions important for proper treatment . Optic neuropathies can be either acute or chronic, with acute optic neuropathies having relatively abrupt onsets, while chronic optic neuropathies have a slow and prolonged development .
However, given that ON patients typically recover near-normal vision over time, they are most helpfully analyzed longitudinally, and by comparison between groups based on time of onset. For example, a basic distinction between acute ON representing subjects with recent onset (e.g., no greater than a month) and remote ON representing subjects with at least one episode of ON at least 1 year prior to the current investigation has been reported .
Traditionally, ophthalmologists rely on measurements of the patient's eye and retina, as well as direct tests of their vision to make a diagnosis. In recent years, magnetic resonance imaging (MRI) has become increasingly valuable in analyzing the impacts of optic neuropathies both on and beyond the optic nerve . Visualization and comparison of the downstream impact that optic neuropathies have on pre- and post-geniculate visual pathway regions as well as regions beyond the visual system form a typically untapped addition to standard neuro-ophthalmological assessments .
Nevertheless, the diagnosis of optic nerve affection and consideration of potential differential diagnoses are important in clinical routine. Especially the identification of its distinct pattern can help to differentiate neuromyelitis optica spectrum disease (NMO-SD) and MOG antibody disease (MOG-AD) from MS or other auto inflammatory illnesses. Further consideration of the optic nerves in follow up examinations of MS patients as one potential disease manifestation is reasonable.
Magnetic resonance imaging plays a pivotal role in diagnosis and exclusion of secondary causes. Conventional MRI sequences, including T1-weighted, T2-weighted, and post-contrast imaging, demonstrate optic nerve swelling and enhancement but provide limited quantitative assessment of axonal and myelin integrity.
Diffusion Tensor Imaging (DTI) is an advanced MRI technique that enables in-vivo assessment of white matter microstructure by measuring the directionality and magnitude of water diffusion.
Quantitative DTI parameters such as fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), and radial diffusivity (RD) reflect axonal damage and demyelination. Traditional anatomical MRI has been extensively used in previous studies to investigate the morphological changes in various brain structures that might accompany disease. The appearance or size of particular grey and white matter regions can be detected and often correlates with important functional and/or clinical variables .
Each voxel in a DTI volume can be represented by an ellipsoid with three principal axes and eigenvectors.The measure along the longest axis which usually runs parallel to the measured axon is referred to as axial diffusivity (AD), while the mean magnitude of flow along the two perpendicular axes is referred to as radial diffusivity (RD). AD and RD measures have shown value in diagnosing axonal damage and myelin damage, respectively .
FA reflects the relative ratio between the anisotropic to isotropic nature of the measured diffusion, with perfectly isotropic diffusion having a value of zero and perfectly anisotropic diffusion having a value of one . An increased MD is commonly associated with damaged tissue because of the resulting increase in free diffusion that this elicits . A relatively high MD can characterize a high level of disorganization, while a low MD represents a highly organized structure .
In contrast, AD and RD values are tied to directional diffusivity and are increasingly representative of microstructural and anatomical details . Nevertheless, it is important to note that these four metrics are not entirely independent: a change in one metric would be expected to affect others .
Several studies have demonstrated alterations in DTI parameters of the optic nerve in optic neuritis; however, the role of DTI in idiopathic optic neuritis remains under-evaluated. This study aims to assess optic nerve microstructural changes using DTI and to correlate imaging findings with clinical and electrophysiological parameters.
In recent years, double inversion recovery (DIR) sequences have been increasingly used. This sequence type uses two different inversion pulses to suppress signals from cerebrospinal fluid (CSF) as well as signals from white matter. This results in a higher lesion-white matter contrast, which improves the detection of cortical lesions and T2-hyperintensities in the infratentorial region specially in MS . Interestingly, lesions of the optic nerves are apparent as well. They revealed the good clinical performance of the DIR in this acute setting. Consequently, we were wondering if DIR sequences are also capable of detecting optic nerve lesions in follow up examinations of optic neuritis patients .
Developing an understanding of how distinct optic neuropathies relate to MRI data metrics can improve the potential for identifying novel biomarkers. This will likely allow for a more integrated and all-encompassing understanding of these conditions with respect to severity, recovery, and treatment.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Merna Nemr, Assistant lecturer
- Phone Number: 01020731292
- Email: monna.merna13@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age above 18 years.
- Clinically suspected optic neuritis.
- Evidence of multiple sclerosis or other demyelinating diseases.
Exclusion Criteria:
- Traumatic optic neuritis.
- Systemic diseases affecting the optic nerve.
- Contraindications to MRI.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy controls
Twenty-eight healthy volunteers without a history of optic neuritis or other optic nerve disorders.
Participants will undergo MRI examination for comparison with the optic neuritis group.
|
DTI and DIR
|
|
Optic Neuritis Patients
Twenty-eight patients diagnosed with optic neuritis who will undergo MRI examination for evaluation of imaging findings.
|
DTI and DIR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fractional anisotropy (FA) value of the affected optic nerve measured by diffusion tensor imaging (DTI)
Time Frame: Baseline At the time of MRI examination
|
Fractional anisotropy (FA) values will be calculated from regions of interest placed along the affected optic nerve and compared between participants with optic neuritis and healthy controls.
|
Baseline At the time of MRI examination
|
|
Mean diffusivity (MD) value of the affected optic nerve measured by diffusion tensor imaging (DTI)
Time Frame: Baseline At Time of MRI examination
|
Mean diffusivity (MD) values will be calculated from regions of interest placed along the affected optic nerve and compared between participants with optic neuritis and healthy controls.
|
Baseline At Time of MRI examination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of optic nerve lesions detected using Double Inversion Recovery MRI.
Time Frame: Baseline At Time of MRI examination
|
The number of optic nerve lesions identified on DIR images will be recorded for each participant.
|
Baseline At Time of MRI examination
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Prof.dr afaf Abdkader Hassan, Professor, Assiut University
- Study Chair: Dr omran Khodary Qenway, Assistant professor, Assiut University
- Study Chair: Dr Samaa Mustafa El kossi, Lecturer, Assiut University
- Study Chair: Dr.asmaa Mohamed Mohamed, Lecturer, Assiut University
Publications and helpful links
General Publications
- Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46.
- Li K, Lu C, Huang Y, Yuan L, Zeng D, Wu K. Alteration of fractional anisotropy and mean diffusivity in glaucoma: novel results of a meta-analysis of diffusion tensor imaging studies. PLoS One. 2014 May 14;9(5):e97445. doi: 10.1371/journal.pone.0097445. eCollection 2014.
- Mendoza M, Shotbolt M, Faiq MA, Parra C, Chan KC. Advanced Diffusion MRI of the Visual System in Glaucoma: From Experimental Animal Models to Humans. Biology (Basel). 2022 Mar 16;11(3):454. doi: 10.3390/biology11030454.
- Kim JD, Hashemi N, Gelman R, Lee AG. Neuroimaging in ophthalmology. Saudi J Ophthalmol. 2012 Oct;26(4):401-7. doi: 10.1016/j.sjopt.2012.07.001.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRI in optic neuritis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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