- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665935
Diffusion Tensor Imaging of Myelopathy (DTI)
Role of Diffusion Tensor Imaging in Evaluation of Myelopathy
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.
Study Overview
Status
Conditions
Detailed 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:
- Conventional MRI sequences: sagittal T1W, sagittal and axial T2W sequences.
- 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Abd El-Karem Hasan, professor
- Phone Number: 01224652032
- Email: abdelkarem_5555@yahoo.com
Study Contact Backup
- Name: Mohamed Zidan, A.professor
- Phone Number: 01001121365
- Email: mzidan74@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical symptoms of myelopathy
Exclusion Criteria:
- Previous spine surgery
- Spine radiation therapy
- Cerebral palsy
- Contraindication to MR imaging.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the usefulness of diffusion tensor imaging (DTI) and fiber tracking in evaluation of myelopathy.
Time Frame: one year
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mona Gouda, ass lecturer, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- DTI in myelopathy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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