NCT06055998

Brief Summary

To identify the frequency of ATM and its different aetiologies, alongside the different clinical and radiological patterns and prognostic factors .

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 11, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 11, 2023

Last Update Submit

September 27, 2023

Conditions

Transverse Myelitis

Outcome Measures

Primary Outcomes (1)

  • 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: 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.

    1 year

Interventions

MRIDEVICE

MRI SPINE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 35936885RESULT

  • Murthy JM, Reddy JJ, Meena AK, Kaul S. Acute transverse myelitis: MR characteristics. Neurol India. 1999 Dec;47(4):290-3.

    PMID: 10625901RESULT

  • Beh 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.

    PMID: 23186897RESULT

  • Christensen 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.

    PMID: 2375246RESULT

  • Bhat 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.

    PMID: 20035902RESULT

  • Debette 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.

    PMID: 19252779RESULT

  • Berman 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.

    PMID: 7196523RESULT

  • Wingerchuk DM. Postinfectious encephalomyelitis. Curr Neurol Neurosci Rep. 2003 May;3(3):256-64. doi: 10.1007/s11910-003-0086-x.

    PMID: 12691631RESULT

  • Jacob 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.

    PMID: 18256991RESULT

  • de 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.

    PMID: 11459743RESULT

  • Frohman 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.

    PMID: 20818891RESULT

  • Dumic 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.

    PMID: 30622896RESULT

  • Transverse 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.

    PMID: 12236201RESULT

MeSH Terms

Conditions

Myelitis, Transverse

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsParaneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesCentral Nervous System DiseasesSpinal Cord DiseasesDemyelinating DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ahmed H Youssef, Professor

    Supervisor

    STUDY DIRECTOR

  • Doaa M Mahmoud, Lecturer

    Supervisor

    STUDY DIRECTOR

Central Study Contacts

Fouad E Fawaz, Resident

CONTACT

+201030698686fouadabdelrahman55@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 28, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

February 1, 2026

Last Updated

September 28, 2023

Record last verified: 2023-09