MyelopathyNCT05257330
Evaluation of Non-Compressive Myelopathy in a Sample of Egyptian Patients
An observational study of Myelopathy and Non-Compressive, run by Al-Azhar University at 1 site in Egypt.
Trial summary
An observational study will be conducted in the Department of Neurology at AlAzhar University Hospitals To study the etiological factors of non-compressive myelopathy in a sample of Egyptian patients Read more about this study
- Who is it for?
- Ages 2 months to 100 years
- Conditions the study is for
- Myelopathy, Non-Compressive
- What is being tested?
- CSF Examination
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute, subacute, or chronic neurologic dysfunction consistent with myelopathy
Who may be able to join
- Patients with acute, subacute, or chronic neurologic dysfunction (motor and sensory deficit, sphincteric involvement, and a well-defined upper sensory segmental level) consistent with myelopathy (with or without coexisting encephalopathy, neuropathy, or radiculopathy).
Who cannot join
- 1) Patients of myelopathy who did not undergo magnetic resonance imaging (MRI) of the spinal cord. 2) Spinal cord compression on MRI explaining patient's neurologic dysfunction. 3) History of previous trauma, acute coma and patients with definite cerebral symptoms incompatible with spinal pathology (e.g., aphasia, hemianopia, neglect, facial involvement). 4) Motor neuron disease (MND) 5)Degenerative ataxias.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Hussein and Sayed Galal Hospitals
Cairo
Mohie-eldin T Mohamed, Professor, +20 115 736 3721, mohie-eldin@azhar.edu.eg
About this study
An observational study will be conducted in the Department of Neurology at AlAzhar University Hospitals To study the etiological factors of non-compressive myelopathy in a sample of Egyptian patients
Read the detailed description
Myelopathy is a collective term referring to any pathologic condition or neurologic deficit related to the spinal cord. Myelopathies are a frequent and potentially disabling neurologic emergency.(Sarbu et al., 2019).
Diseases of the spinal cord often have devastating consequences and imaging studies are indispensable for their diagnosis. The diagnostic approach must be based on the clinical context, the time elapsed since the onset of symptoms and signs, and the imaging findings (Herrera et al., 2020).
Myelopathies may be compressive or non-compressive, regarding to subarachnoid space obstruction (Kundu et al., 2018).
Noncompressive myelopathy (NCM) is described as "spinal cord involvement without detectable clinical and radiological evidence of spinal cord compression causing neurological deficit (Thangaraj et al., 2019).
There have been a few studies that have investigated Noncompressive myelopathy (NCM) in Africa as part of nontraumatic myelopathy. With very few studies focusing on NMOSD, Most of them focus on extrinsic compression and infectious diseases as important causes of myelopathy (Musubire et al., 2021) Comprehensive data on Egyptian patients with Non-compressive myelopathy (NCM) in the light of newer diagnostic criteria and serological tests are lacking. No study has been conducted to study the clinico-radiological profile of Non-compressive myelopathy (NCM) so far. In this study, we are putting an effort to convey our experience on etiological pattern of Non-compressive myelopathy (NCM) with special reference to its radiological features.
- Conditions
- Myelopathy, Non-Compressive
- Being tested
- CSF Examination
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF ExaminationDiagnostic test
Lumbar puncture for CSF Examination
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the etiological factors of non-compressive myelopathy in a sample of Egyptian patients
study the clinico-radiological profile of Non-compressive myelopathy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelopathyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdel-Ghaffar Ismail Fayed, Al-Azhar University
- Investigators
- Mohie-eldin T Mohamed, Professor, Principal investigator, Al-Azhar Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257330
- Sponsor's protocol ID
- 0000044
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To study the etiological factors of Non-compressive Myelopathy in a sample of Egyptian patients
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Compressive Myelopathy in a Sample of Egyptian Patients
- ClinicalTrials.gov ID
- NCT05257330
- Acronym / sponsor ID
- 0000044
- Conditions
- Myelopathy, Non-Compressive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study will be conducted in the Department of Neurology at AlAzhar University Hospitals To study the etiological factors of non-compressive myelopathy in a sample of Egyptian patients
Detailed description
Myelopathy is a collective term referring to any pathologic condition or neurologic deficit related to the spinal cord. Myelopathies are a frequent and potentially disabling neurologic emergency.(Sarbu et al., 2019).
Diseases of the spinal cord often have devastating consequences and imaging studies are indispensable for their diagnosis. The diagnostic approach must be based on the clinical context, the time elapsed since the onset of symptoms and signs, and the imaging findings (Herrera et al., 2020).
Myelopathies may be compressive or non-compressive, regarding to subarachnoid space obstruction (Kundu et al., 2018).
Noncompressive myelopathy (NCM) is described as "spinal cord involvement without detectable clinical and radiological evidence of spinal cord compression causing neurological deficit (Thangaraj et al., 2019).
There have been a few studies that have investigated Noncompressive myelopathy (NCM) in Africa as part of nontraumatic myelopathy. With very few studies focusing on NMOSD, Most of them focus on extrinsic compression and infectious diseases as important causes of myelopathy (Musubire et al., 2021) Comprehensive data on Egyptian patients with Non-compressive myelopathy (NCM) in the light of newer diagnostic criteria and serological tests are lacking. No study has been conducted to study the clinico-radiological profile of Non-compressive myelopathy (NCM) so far. In this study, we are putting an effort to convey our experience on etiological pattern of Non-compressive myelopathy (NCM) with special reference to its radiological features.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute, subacute, or chronic neurologic dysfunction consistent with myelopathy
Key inclusion criteria (1 listed)
- Patients with acute, subacute, or chronic neurologic dysfunction (motor and sensory deficit, sphincteric involvement, and a well-defined upper sensory segmental level) consistent with myelopathy (with or without coexisting encephalopathy, neuropathy, or radiculopathy).
Key exclusion criteria (1 listed)
- 1) Patients of myelopathy who did not undergo magnetic resonance imaging (MRI) of the spinal cord. 2) Spinal cord compression on MRI explaining patient's neurologic dysfunction. 3) History of previous trauma, acute coma and patients with definite cerebral symptoms incompatible with spinal pathology (e.g., aphasia, hemianopia, neglect, facial involvement). 4) Motor neuron disease (MND) 5)Degenerative ataxias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF ExaminationLumbar puncture for CSF Examination | Diagnostic test | – |
Primary outcome
To study the etiological factors of non-compressive myelopathy in a sample of Egyptian patients
Time frame: 6 months
study the clinico-radiological profile of Non-compressive myelopathy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: Undecided. To study the etiological factors of Non-compressive Myelopathy in a sample of Egyptian patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohie-eldin T Mohamed, Professor principal investigator
Al-Azhar Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelopathy and Non-Compressive, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Islam S Al-Emam, MSC (+201027759946, eslamsalman211@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the etiological factors of non-compressive myelopathy in a sample of Egyptian patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.