Frequency ,Etiology and Prognostic Factors of Acute Transverse Myelitis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06055998
Collaborator
(none)
50
26.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: MRI

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

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Frequency ,Etiology and Prognostic Factors of Acute Transverse Myelitis in Neurology and Psychiatry Department, Assiut University
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Feb 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Determine the relative frequency of different aetiologies of ATM among Southern Egyptian patients attending Assiut University Hospital [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: 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
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 21 days.

Exclusion Criteria:
  1. 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.

  2. Incomplete clinical, laboratory or radiographic data.

  3. Patients refused to sign the informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Ahmed H Youssef, Professor, Supervisor
  • Study Director: Doaa M Mahmoud, Lecturer, Supervisor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fouad E Fawaz, Resident Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT06055998
Other Study ID Numbers:
  • acute transverse myelitis
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023