Health Condition 1: G35-G37- Demyelinating diseases of the central nervous system
Conditions
Interventions
Intervention1: Methylcobalamin: Injection Methylcobalamin 1500 mcg/ns100cc i.v. for 5 days followed by oral methylcobalamin 3000 mcg once daily for 1 month in addition to the standard care as per guid
Sponsors
Shuchismita Kesarwani
Eligibility
Inclusion criteria
Inclusion criteria: 1.Acute episode of a suspected central nervous system demyelination. 2.Either Optic neuritis or Myelitis 3.Known diagnosis of MS, NMOSD, MOGAD, seronegative demyelination by predefined criteria. 4.First ever acute demyelinating event 5.Within 7 days of onset of symptoms. 6.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Baseline visual acuity worse than 6/24 in the currently symptomatic eye 2.Baseline Kurtzke (EDSS) pyramidal functional sub-score more than 2. 3.Previous disability of mRS 3 or more 4.Combined optic neuritis and myelitis in the current episode. 5.Patients who have received methylcobalamin supplementation in the preceding three months. 6.Treatment for relapse with standard interventions already initiated for more than 7 days 7.Patient already on methylcobalamin supplementation (daily dose more than 100 mcg) 8.Patients with vitamin B12 levels 9.Pre-existing ocular abnormalities that affect assessment of ocular function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optic Neuritis Change in Visual acuity (Snellen score to Log MAR conversion) at 3 months estimated as proportion of episodes of optic neuritis achieving good outcome defined by improvement in visual acuity by 2 lines on Snellen chart / 0.2 log units improvement. Myelitis Mean Delta EDSS change at 3 months from baseline. Good outcome shall be defined as a proportion of episodes achieving either complete or 66% mean delta change improvement from baseline.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Optic neuritis group 1.Mean Delta EDSS change at 3 months from baseline. 2.Improvement of visual acuity & EDSS over time as measured at different time points. 3.Change in Contrast sensitivity (Pelli Robson chart) 4.Change in OCT (ocular coherence tomography) Myelitis group 1.Mean Delta EDSS change at 3 months from baseline. 2.Improvement of EDSS over time as measured at different time points. 3.Change in Ambulation index on EDSS & 25 feet walk test. Common to Optic neuritis & Myelitis group Change in MSQOL-54 (Multiple Sclerosis quality of life instrument)Timepoint: Optic neuritis Group- Visual acuity, EDSS, Contrast Vision at recruitment,15days,1 month & 3 months, OCT & MSQOL at recruitment & 3 months. Myelitis Group- EDSS, Ambulation Index & 25 feet walk test at recruitment, 15 days, 1 month & 3 months, MSQOL at recruitment & 3 months. | — |
Countries
India
Contacts
Public ContactShuchismita Kesarwani
AIIMS, New Delhi
Outcome results
None listed