NCT03665935

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 6, 2018

Last Update Submit

September 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A 70 patient with myelopathy will be included in the study. the study will be performed at radiology department in Assiut University Hospital. Using Magnetic Resonance imaging device 1.5 tesla scanners. First imaging the spine by acquiring the conventional sequences and second the diffusion tensor sequence.

You may qualify if:

  • Clinical symptoms of myelopathy

You may not qualify if:

  • Previous spine surgery
  • Spine radiation therapy
  • Cerebral palsy
  • Contraindication to MR imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 22013299BACKGROUND

MeSH Terms

Conditions

Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Officials

  • Mona Gouda, ass lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abd El-Karem Hasan, professor

CONTACT

Mohamed Zidan, A.professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 11, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

September 11, 2018

Record last verified: 2018-09