Mycobacteria infection in incomplete transverse myelitis

Completed

• Conditions: Incomplete transverse myelitis (ITM); Nervous System Diseases; Encephalitis, myelitis and encephalomyelitis

• Registration Number: ISRCTN57081310
• Lead Sponsor: Sun Yat-sen University (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. Development of sensory, motor, or autonomic dysfunction attributable to the spinal cord
2. Varying degrees of motor, sensory and sphincter dysfunction (though not necessarily symmetrical), but without complete paraplegia
3. Exclusion of extra-axial compressive aetiology by magnetic resonance imaging (MRI)
4. Worsened condition despite at least one 5-day course of intravenous (IV) methylprednisolone (0.5 - 1 g/d)
5. Cerebrospinal fluid mycobacterium tuberculosis (CSF MTB) culture were negative, with cell count less than 50/mm^3 and total protein less than 1.5 g/L
6. Aged 18 - 70 years, either sex

Exclusion Criteria

1. Sudden onset
2. History of previous radiation to the spine within the last 10 years
3. Central nervous system (CNS) manifestations of syphilis, Lyme disease, human immunodeficiency virus (HIV) infection
4. Clear arterial distribution clinical deficit consistent with thrombosis of the anterior spinal artery
5. History of clinically apparent optic neuritis
6. Brain MRI abnormalities suggestive of multiple sclerosis (MS) and clinically definite MS
7. Serologic or clinical evidence of connective tissue disease (sarcoidosis, Behcet's disease, Sjögren's syndrome, systematic lupus erythematosis [SLE], mixed connective tissue disorder, etc)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Before the start of the assigned treatment all patients had a baseline visit, at which the medical history was obtained, and physical and neurological examinations were undertaken. The American Spinal Injury Association (ASIA) standards were adopted to assess subjects' neurological status. We used the ASIA Impairment Scale to evaluate sensory and motor function and neurological level. Activities of daily living (ADL) were assessed by Barthel Index (BI) (0 - 100 scale, with lower scores denoting less independence in activities of daily living); mobility were scored by the Hauser Ambulation Index.

Secondary Outcome Measures

Name	Time	Method
1. Changes in quality of life, measured by the ASIA, BI and AI at baseline and at 12 months<br>2. MRI changes assessed at baseline and at 12 months<br><br>Each patient was followed up and assessed by the same physician during the study.