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DTI & DIR in Optic Neuritis (DTI & DIR)

31 de julio de 2026 actualizado por: Merna youssef nemr, Assiut University

MRI Evaluation of Optic Neuritis : Integrating Double Inversion Recovery and Diffusion Tensor Imaging .

To evaluate the role of Double Inversion Recovery (DIR) and Diffusion Tensor Imaging (DTI) in the assessment of optic neuritis and to correlate imaging findings with clinical and visual outcomes.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

56

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Merna Nemr, Assistant lecturer
  • Número de teléfono: 01020731292
  • Correo electrónico: monna.merna13@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Adults with clinically suspected optic neuritis referred for MRI evaluation, together with healthy control participants.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fractional anisotropy (FA) value of the affected optic nerve measured by diffusion tensor imaging (DTI)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of optic nerve lesions detected using Double Inversion Recovery MRI.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Prof.dr afaf Abdkader Hassan, Professor, Assiut University
  • Silla de estudio: Dr omran Khodary Qenway, Assistant professor, Assiut University
  • Silla de estudio: Dr Samaa Mustafa El kossi, Lecturer, Assiut University
  • Silla de estudio: Dr.asmaa Mohamed Mohamed, Lecturer, Assiut University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

30 de abril de 2028

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

1 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2026

Publicado por primera vez (Actual)

6 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de julio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • MRI in optic neuritis

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .