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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03665935
Other study ID # DTI in myelopathy
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2018
Est. completion date December 2019

Study information

Verified date September 2018
Source Assiut University
Contact Abd El-Karem Hasan, professor
Phone 01224652032
Email abdelkarem_5555@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Myelopathy describes any neurologic deficit related to the spinal cord. Myelopathy is caused by various pathological states of the human spinal cord, including tumors, inflammatory lesions, spinal cord compression and degenerative myelopathy. Clinically, the diagnosis of myelopathy depends on localization of the neurologic finding to the spinal cord, rather than the brain or peripheral nervous system and then to a particular segment of the spinal cord.

Magnetic resonance imaging (MRI) plays an essential role in the diagnosis and follow-up of the lesions of the spinal cord using conventional MRI T1- and T2-weighted sequences. Sometimes a studied spinal cord may appear normal on conventional MRI even though patients have symptoms of myelopathy causing a discrepancy between MRI findings and clinical findings.

Diffusion tensor imaging (DTI) is an advanced non-invasive MR imaging technique which assesses the microstructural integrity of nerve fiber tracts.


Description:

A number of 70 patient with myelopathy included within the study.

DTI is used primarily for assessing white matter of the brain and spinal cord. DTI can depict alterations to the white matter tract and quantify these changes. Disturbances of diffusion (restriction or increase) may be assessed quantitatively by measurements of apparent diffusion coefficient (ADC). The apparent diffusion coefficient (ADC), is used to measure diffusive strength. Diffusion anisotropy can be assessed quantitatively by using the fractional anisotropy (FA) parameter, which may be also visualized on fractional anisotropy maps. FA is considered as a marker of white matter integrity.

Image acquisition will be conducted on a 1.5-Tesla MR scanner.

The imaging will be done throughout the following sequences:

1. Conventional MRI sequences: sagittal T1W, sagittal and axial T2W sequences.

2. DTI sequence: Single-shot spin-echo echo-planar imaging (EPI) and parallel imaging techniques to achieve motion-free and higher signal-to-noise ratio (SNR) DTI.

Post processing:

The diffusion-tensor imaging data is transferred to an offline workstation utilizing software used for reconstruction of the Diffusion Tensor imaging (DTI) with regions of interest were defined and measured on the ADC and fractional anisotropy (FA) maps. diffusion tensor tractogram will be constructed on the acquired data source.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Clinical symptoms of myelopathy

Exclusion Criteria:

- Previous spine surgery

- Spine radiation therapy

- Cerebral palsy

- Contraindication to MR imaging.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Kamble RB, Venkataramana NK, Naik AL, Rao SV. Diffusion tensor imaging in spinal cord injury. Indian J Radiol Imaging. 2011 Jul;21(3):221-4. doi: 10.4103/0971-3026.85372. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the usefulness of diffusion tensor imaging (DTI) and fiber tracking in evaluation of myelopathy. assessing white matter tract affection in various disease and damage involving the spinal cord using the DTI indices, quantitatively using ADC and FA measurement and qualitatively using tractogram to assess spinal cord lesions and compare the results to conventional MRI sequences one year
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