Topic: Children, Neurological disorders
Conditions
Interventions
Admin of immunoglobulin, Eligible participants will be randomised to treatment or control group.
1. Participants randomised to the control arm of this study will be prescribed intraven
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for inclusion on the trial if on presentation they: 1. Are aged 1 year or over 2. Have been diagnosed with: 2.1. EITHER acute first onset transverse myelitis (The TM CONSORTIUM WORKING GROUP 2002 criteria for probable TM will be used. Hence, following clinical and radiological exclusion of a compressive myelopathy, patient will be diagnosed to have TM if they meet all the following criteria: 2.1.1. Sensory, motor, or autonomic dysfunction attributable to the spinal cord 2.1.2. Bilateral signs and/or symptoms (not necessarily symmetric) 2.1.3. Sensory level (except in young children <5 years where this is difficult to evaluate) 2.1.4. Lack of MRI brain criteria consistent with MS (McDonald 2010 space criteria) 2.1.5. Progression to nadir between 4 h and 21 days) 2.2. OR Have been diagnosed with first presentation of neuromyelitis optica. (Patients with definite modified NMO will meet the following criteria (Wingerchuck et al, 2006). Absolute criteria, both: 2.2.1. Optic neuritis 2.2.2. Acute myelitis 2.3. Plus two out of three supportive criteria: 2.3.1. Brain MRI not meeting criteria for MS at disease onset 2.3.2. Spinal cord MRI with contiguous T2weighted signal abnormality extending over three or more vertebral segments, indicating a relatively large lesion in the spinal cord 2.3.3. AQP 4 seropositive status) 3. Have an ASIA Impairment score of A, B or C 4. Have commenced steroid treatment but will be randomised no later than day 5 of steroids, and if definitely known, randomisation will not exceed 21 days from the onset of symptoms 5. Give assent (8-16 years)/consent to participate in the trial
Exclusion criteria
Exclusion criteria: Patients would be excluded if they show evidence of: 1. Contraindication to IVIg as stated in the product SmPC, or receiving IVIG for other reasons 2. Previously known systemic autoimmune disease (eg systemic lupus erythematosus) or any evidence of systemic inflammation during current presentation. 3. Direct infectious aetiology (eg varicella zoster) 4. Previous episode of CNS inflammatory demyelination 5. Acute disseminated encephalomyelitis (ADEM) 6. Other causes of myelopathy not thought to be due to myelitis (eg nutritional, ischaemic, tumour etc.) 7. Other disease which would interfere with assessment of outcome measures 8. Pregnancy 9. Circumstances which would prevent follow-up for 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of 2 points or greater on the ASIA Impairment scale (classfiied A-E); Timepoint(s): 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in ASIA motor scale (0-100) and ASIA sensory scale (0-112) at 3, 6, and 12 months post randomisation 2. Change in Kurtzke expanded disability status scale (EDSS) measured by Neurostatus scoring at 3, 6, and 12 months 3. EQ-5D-Y for patients aged 8-12 years (at presentation) at 3,6 and 12 months post randomisation 4. EQ-5D-5L for patients aged = 13 years (at presentation) at 3, 6 and 12 months post randomisation 5. Individuals = 13 years at presentation: International SCI Quality of Life Basic Data Set at 3, 6 and 12 months post randomisation 6. Client Service Receipt Inventory (CSRI) at 3, 6 and 12 months post randomisation | — |
Countries
United Kingdom
Outcome results
None listed