Transverse MyelitisNCT06055998
Frequency ,Etiology and Prognostic Factors of Acute Transverse Myelitis
An observational study of Transverse Myelitis, run by Assiut University.
Trial summary
To identify the frequency of ATM and its different aetiologies, alongside the different clinical and radiological patterns and prognostic factors . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transverse Myelitis
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Feb 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cases of all ages and both sex attending the neurology and psychiatry department at Assiut University Hospital during one year period who meet the diagnostic criteria of ATM according to the TM Consortium Working Group (TMCWG) in 2002 will be recriuted
Who may be able to join
- Diagnostic criteria include:
- Sensory, motor, or autonomic dysfunction originating from the spinal cord
- T2 hyperintense signal changes on MRI
- No evidence of a compressive lesion
- Bilateral signs/symptoms.
- Clearly defined sensory level.
- Evidence of inflammatory process demonstrated by gadolinium enhancement on MRI, cerebrospinal fluid (CSF) analysis showing pleocytosis, or elevated immunoglobulin G (IgG) index.
- Progression to nadir between 4 hours and 21 days.
Who cannot join
- An alternative diagnosis became apparent any time along the study period including evidence of compressive lesion in MRI, history of previous radiation to the spine within the past 10 years, clinical deficit consistent with thrombosis of the anterior spinal artery or Abnormal flow voids on the surface of the spinal cord consistent with AVFs.
- Incomplete clinical, laboratory or radiographic data.
- Patients refused to sign the informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frequency ,Etiology and Prognostic Factors of Acute Transverse Myelitis in Neurology and Psychiatry Department, Assiut University
To identify the frequency of ATM and its different aetiologies, alongside the different clinical and radiological patterns and prognostic factors .
Read the detailed description
Acute transverse myelitis (ATM) is an inflammatory condition of the spinal cord, covering the entire cross section and spreading on two or more vertebral segments, without evidence of a compressive lesion.1 This shows clinically as acute or subacute spinal cord dysfunction resulting in paresis, sensory level, and autonomic (bladder, bowel, and sexual) impairment below the level of the lesion.2 ATM is typically classified as either idiopathic ATM where no causative factor found or disease- associated transverse myelitis.3 Disease- associated transverse myelitis results from heterogenous pathophysiologic causes including infectious, parainfectious, paraneoplastic, drug/toxin-induced, systemic autoimmune disorders (SAIDs), Neurosarcoidosis and acquired demyelinating diseases like multiple sclerosis (MS) or neuromyelitis optica (NMO).4 5 6 The annual incidence of ATM ranges from 1.34 to 4.60 cases per million,7 8 but increases to 24.6 cases per million if acquired demyelinating diseases like MS are included.9 TM can occur at any age, although a bimodal peak in incidence occurs in the second and fourth decades of life.7 8 10 This broad differential can overlap with noninflammatory myelopathies and can be very challenging for clinicians to navigate, causing delays in diagnosis or treatment.11 MRI is essential to rule out compressive causes of these neurologic manifestations, such as tumour, epidural abscess, herniated disc, stenosis of the medullary canal or hematoma. It is also used to show the extension of the lesion and for follow-up progress of these lesions after treatment.12 The lack of large-scale and longitudinal studies has hindered the understanding of this complex disorder.
Approximately 33% of patients recover with little to no lasting deficits, 33% have a moderate degree of permanent disability, and 33% are permanently disabled.13 The disease is often a monophasic illness and will only not recur unless it is secondary to a chronic comorbid condition, highlight the need for early and prompt recognition of aetiology. Steroids and immunosuppression are the only potential treatments for ATM at this time, but there is potential for monoclonal antibody drugs that might alter the disease course if an autoinflammatory process was identified. Although individuals affected by ATM show residual neurologic deficits if they have not recovered to normal within 3-6 months, no report has considered earlier factors that might determine the prognosis of the illness. The objective of this study was to determine frequency of ATM and its different etiologies, clinical and radiological patterns, and the different prognostic factors associated in a large tertiary center in the south of Egypt with a goal to improve awareness of ATM to ensure prompt recognition and treatment
- Conditions
- Transverse Myelitis
- Being tested
- MRI
- Medical subject headings
- Myelitis, Transverse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI SPINE
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the relative frequency of different aetiologies of ATM among Southern Egyptian patients attending Assiut University Hospital
All cases of all ages and both sex attending the neurology and psychiatry department at Assiut University Hospital during one year period who meet the diagnostic criteria of ATM according to the TM
Consortium Working Group (TMCWG) in 2002 will be recriuted.1 Diagnostic criteria include:
- Sensory, motor, or autonomic dysfunction originating from the spinal cord
- T2 hyperintense signal changes on MRI
- No evidence of a compressive lesion
- Bilateral signs/symptoms.
- Clearly defined sensory level.
- Evidence of inflammatory process demonstrated by gadolinium enhancement on MRI, cerebrospinal fluid (CSF) analysis showing pleocytosis, or elevated immunoglobulin G (IgG) index.
- Progression to nadir between 4 hours and 21days.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Transverse MyelitisStudies of the same condition, open and under way.
- More trials run by Assiut 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 crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouad E Fawaz, Assiut University
- Investigators
- Ahmed H Youssef, Professor, Study director, SupervisorDoaa M Mahmoud, Lecturer, Study director, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055998
- Sponsor's protocol ID
- acute transverse myelitis
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harizi E, Shemsi K, Kola E, Hyseni F, Kola I, Siddique MA, Sadeque J, Decka A, Dervishi M, Nasir F, Capi L, Ayala I, Ghosh AS, Swarna SS, Musa J, Ahmetgjekaj I. Transverse myelitis in a 26-year-old male with tuberculosis. Radiol Case Rep. 2022 Aug 1;17(10):3669-3673. doi: 10.1016/j.radcr.2022.06.091. eCollection 2022 Oct.
PubMed 35936885Murthy JM, Reddy JJ, Meena AK, Kaul S. Acute transverse myelitis: MR characteristics. Neurol India. 1999 Dec;47(4):290-3.
PubMed 10625901Beh SC, Greenberg BM, Frohman T, Frohman EM. Transverse myelitis. Neurol Clin. 2013 Feb;31(1):79-138. doi: 10.1016/j.ncl.2012.09.008.
PubMed 23186897Christensen PB, Wermuth L, Hinge HH, Bomers K. Clinical course and long-term prognosis of acute transverse myelopathy. Acta Neurol Scand. 1990 May;81(5):431-5. doi: 10.1111/j.1600-0404.1990.tb00990.x.
PubMed 2375246Bhat A, Naguwa S, Cheema G, Gershwin ME. The epidemiology of transverse myelitis. Autoimmun Rev. 2010 Mar;9(5):A395-9. doi: 10.1016/j.autrev.2009.12.007. Epub 2009 Dec 24.
PubMed 20035902Debette S, de Seze J, Pruvo JP, Zephir H, Pasquier F, Leys D, Vermersch P. Long-term outcome of acute and subacute myelopathies. J Neurol. 2009 Jun;256(6):980-8. doi: 10.1007/s00415-009-5058-x. Epub 2009 Feb 28.
PubMed 19252779Berman M, Feldman S, Alter M, Zilber N, Kahana E. Acute transverse myelitis: incidence and etiologic considerations. Neurology. 1981 Aug;31(8):966-71. doi: 10.1212/wnl.31.8.966.
PubMed 7196523Wingerchuk DM. Postinfectious encephalomyelitis. Curr Neurol Neurosci Rep. 2003 May;3(3):256-64. doi: 10.1007/s11910-003-0086-x.
PubMed 12691631Jacob A, Weinshenker BG. An approach to the diagnosis of acute transverse myelitis. Semin Neurol. 2008 Feb;28(1):105-20. doi: 10.1055/s-2007-1019132.
PubMed 18256991de Seze J, Stojkovic T, Breteau G, Lucas C, Michon-Pasturel U, Gauvrit JY, Hachulla E, Mounier-Vehier F, Pruvo JP, Leys D, Destee A, Hatron PY, Vermersch P. Acute myelopathies: Clinical, laboratory and outcome profiles in 79 cases. Brain. 2001 Aug;124(Pt 8):1509-21. doi: 10.1093/brain/124.8.1509.
PubMed 11459743Frohman EM, Wingerchuk DM. Clinical practice. Transverse myelitis. N Engl J Med. 2010 Aug 5;363(6):564-72. doi: 10.1056/NEJMcp1001112. No abstract available.
PubMed 20818891Dumic I, Vitorovic D, Spritzer S, Sviggum E, Patel J, Ramanan P. Acute transverse myelitis - A rare clinical manifestation of Lyme neuroborreliosis. IDCases. 2018 Dec 29;15:e00479. doi: 10.1016/j.idcr.2018.e00479. eCollection 2019.
PubMed 30622896Transverse Myelitis Consortium Working Group. Proposed diagnostic criteria and nosology of acute transverse myelitis. Neurology. 2002 Aug 27;59(4):499-505. doi: 10.1212/wnl.59.4.499.
PubMed 12236201
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency ,Etiology and Prognostic Factors of Acute Transverse Myelitis in Neurology and Psychiatry Department, Assiut University
- ClinicalTrials.gov ID
- NCT06055998
- Acronym / sponsor ID
- acute transverse myelitis
- Conditions
- Transverse Myelitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 28 Sep 2023 (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.
To identify the frequency of ATM and its different aetiologies, alongside the different clinical and radiological patterns and prognostic factors .
Detailed description
Acute transverse myelitis (ATM) is an inflammatory condition of the spinal cord, covering the entire cross section and spreading on two or more vertebral segments, without evidence of a compressive lesion.1 This shows clinically as acute or subacute spinal cord dysfunction resulting in paresis, sensory level, and autonomic (bladder, bowel, and sexual) impairment below the level of the lesion.2 ATM is typically classified as either idiopathic ATM where no causative factor found or disease- associated transverse myelitis.3 Disease- associated transverse myelitis results from heterogenous pathophysiologic causes including infectious, parainfectious, paraneoplastic, drug/toxin-induced, systemic autoimmune disorders (SAIDs), Neurosarcoidosis and acquired demyelinating diseases like multiple sclerosis (MS) or neuromyelitis optica (NMO).4 5 6 The annual incidence of ATM ranges from 1.34 to 4.60 cases per million,7 8 but increases to 24.6 cases per million if acquired demyelinating diseases like MS are included.9 TM can occur at any age, although a bimodal peak in incidence occurs in the second and fourth decades of life.7 8 10 This broad differential can overlap with noninflammatory myelopathies and can be very challenging for clinicians to navigate, causing delays in diagnosis or treatment.11 MRI is essential to rule out compressive causes of these neurologic manifestations, such as tumour, epidural abscess, herniated disc, stenosis of the medullary canal or hematoma. It is also used to show the extension of the lesion and for follow-up progress of these lesions after treatment.12 The lack of large-scale and longitudinal studies has hindered the understanding of this complex disorder.
Approximately 33% of patients recover with little to no lasting deficits, 33% have a moderate degree of permanent disability, and 33% are permanently disabled.13 The disease is often a monophasic illness and will only not recur unless it is secondary to a chronic comorbid condition, highlight the need for early and prompt recognition of aetiology. Steroids and immunosuppression are the only potential treatments for ATM at this time, but there is potential for monoclonal antibody drugs that might alter the disease course if an autoinflammatory process was identified. Although individuals affected by ATM show residual neurologic deficits if they have not recovered to normal within 3-6 months, no report has considered earlier factors that might determine the prognosis of the illness. The objective of this study was to determine frequency of ATM and its different etiologies, clinical and radiological patterns, and the different prognostic factors associated in a large tertiary center in the south of Egypt with a goal to improve awareness of ATM to ensure prompt recognition and treatment
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cases of all ages and both sex attending the neurology and psychiatry department at Assiut University Hospital during one year period who meet the diagnostic criteria of ATM according to the TM Consortium Working Group (TMCWG) in 2002 will be recriuted
Key inclusion criteria (8 listed)
- Sensory, motor, or autonomic dysfunction originating from the spinal cord
- T2 hyperintense signal changes on MRI
- No evidence of a compressive lesion
- Bilateral signs/symptoms.
- Clearly defined sensory level.
Key exclusion criteria (3 listed)
- An alternative diagnosis became apparent any time along the study period including evidence of compressive lesion in MRI, history of previous radiation to the spine within the past 10 years, clinical deficit consistent with thrombosis of the anterior spinal artery or Abnormal flow voids on the surface of the spinal cord consistent with AVFs.
- Incomplete clinical, laboratory or radiographic data.
- Patients refused to sign the informed consent
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 |
|---|---|---|
| MRIMRI SPINE | Device | – |
Primary outcome
Determine the relative frequency of different aetiologies of ATM among Southern Egyptian patients attending Assiut University Hospital
Time frame: 1 year
All cases of all ages and both sex attending the neurology and psychiatry department at Assiut University Hospital during one year period who meet the diagnostic criteria of ATM according to the TM Consortium Working Group (TMCWG) in 2002 will be recriuted.1 Diagnostic criteria include: 1. Sensory, motor, or autonomic dysfunction originating from the spinal cord 2. T2 hyperintense signal changes on MRI 3. No evidence of a compressive lesion 4. Bilateral signs/symptoms. 5. Clearly defined sensory level. 6. Evidence of inflammatory process demonstrated by gadolinium enhancement on MRI, cerebrospinal fluid (CSF) analysis showing pleocytosis, or elevated immunoglobulin G (IgG) index. 7. Progression to nadir between 4 hours and 21days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 35936885Harizi E, Shemsi K, Kola E, Hyseni F, Kola I, Siddique MA, Sadeque J, Decka A, Dervishi M, Nasir F, Capi L, Ayala I, Ghosh AS, Swarna SS, Musa J, Ahmetgjekaj I. Transverse myelitis in a 26-year-old male with tuberculosis. Radiol Case Rep. 2022 Aug 1;17(10):3669-3673. doi: 10.1016/j.radcr.2022.06.091. eCollection 2022 Oct.
- Results publication: PubMed 10625901Murthy JM, Reddy JJ, Meena AK, Kaul S. Acute transverse myelitis: MR characteristics. Neurol India. 1999 Dec;47(4):290-3.
- Results publication: PubMed 23186897Beh SC, Greenberg BM, Frohman T, Frohman EM. Transverse myelitis. Neurol Clin. 2013 Feb;31(1):79-138. doi: 10.1016/j.ncl.2012.09.008.
- Results publication: PubMed 2375246Christensen PB, Wermuth L, Hinge HH, Bomers K. Clinical course and long-term prognosis of acute transverse myelopathy. Acta Neurol Scand. 1990 May;81(5):431-5. doi: 10.1111/j.1600-0404.1990.tb00990.x.
- Results publication: PubMed 20035902Bhat A, Naguwa S, Cheema G, Gershwin ME. The epidemiology of transverse myelitis. Autoimmun Rev. 2010 Mar;9(5):A395-9. doi: 10.1016/j.autrev.2009.12.007. Epub 2009 Dec 24.
- Results publication: PubMed 19252779Debette S, de Seze J, Pruvo JP, Zephir H, Pasquier F, Leys D, Vermersch P. Long-term outcome of acute and subacute myelopathies. J Neurol. 2009 Jun;256(6):980-8. doi: 10.1007/s00415-009-5058-x. Epub 2009 Feb 28.
- Results publication: PubMed 7196523Berman M, Feldman S, Alter M, Zilber N, Kahana E. Acute transverse myelitis: incidence and etiologic considerations. Neurology. 1981 Aug;31(8):966-71. doi: 10.1212/wnl.31.8.966.
- Results publication: PubMed 12691631Wingerchuk DM. Postinfectious encephalomyelitis. Curr Neurol Neurosci Rep. 2003 May;3(3):256-64. doi: 10.1007/s11910-003-0086-x.
- Results publication: PubMed 18256991Jacob A, Weinshenker BG. An approach to the diagnosis of acute transverse myelitis. Semin Neurol. 2008 Feb;28(1):105-20. doi: 10.1055/s-2007-1019132.
- Results publication: PubMed 11459743de Seze J, Stojkovic T, Breteau G, Lucas C, Michon-Pasturel U, Gauvrit JY, Hachulla E, Mounier-Vehier F, Pruvo JP, Leys D, Destee A, Hatron PY, Vermersch P. Acute myelopathies: Clinical, laboratory and outcome profiles in 79 cases. Brain. 2001 Aug;124(Pt 8):1509-21. doi: 10.1093/brain/124.8.1509.
- Results publication: PubMed 20818891Frohman EM, Wingerchuk DM. Clinical practice. Transverse myelitis. N Engl J Med. 2010 Aug 5;363(6):564-72. doi: 10.1056/NEJMcp1001112. No abstract available.
- Results publication: PubMed 30622896Dumic I, Vitorovic D, Spritzer S, Sviggum E, Patel J, Ramanan P. Acute transverse myelitis - A rare clinical manifestation of Lyme neuroborreliosis. IDCases. 2018 Dec 29;15:e00479. doi: 10.1016/j.idcr.2018.e00479. eCollection 2019.
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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.
Ahmed H Youssef, Professor study director
Supervisor
Doaa M Mahmoud, Lecturer study director
Supervisor
Questions about this trial
What is this clinical trial studying?
An observational study of Transverse Myelitis, run by Assiut University.
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 8 inclusion and 3 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Fouad E Fawaz, Resident (+201030698686, fouadabdelrahman55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the relative frequency of different aetiologies of ATM among Southern Egyptian patients attending Assiut University Hospital (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055998, which also lists 13 linked publications.
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 28 Sep 2023.