Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients of Relapsing Remitting Multiple Sclerosis (RRMS)on disease modifying agents (DMAs)
Exclusion criteria
Exclusion criteria: 1. Progressive course of Multiple Sclerosis (MS) 2. Patient with concomitant/ associated etiologies that could affect the cognition and behavioural changes; alcoholism; psychiatric disturbances unrelated to MS, vitamin B12 deficiency 3. Pregnancy 4. Previous head trauma 5. Patient with profound cognitive impairment (MMSE 6. Patient who had a history of acute attack of RRMS in the past 3 months 7. EDSS > 5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction of disability rate 2. No evidence of relapse 3. Decrease in lesion load on MRI 4. No evidence of decline in grey matter atrophy on Brain MRITimepoint: 1. Clinical assessment - baseline, after 10 days of supervised sessions and at the end of 1, 3, 6 and 12 months. 2. Radiological assessment - at baseline and at the end of 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical assessments 2. Biological assessment 3. Radiological assessment 4. Cognitive assessmentTimepoint: 1. Clinical assessments - shall be done at six time points: baseline, after 10 days of supervised sessions and at the end of 1, 3, 6 and 12 months. 2. Biological assessment ââ?¬â??at baseline and at the end of 6 months 3. Radiological assessment - at baseline and at the end of 6 months 4. Cognitive assessment ââ?¬â?? shall be done at three time points-baseline,6 and 12 months | — |
Countries
India
Contacts
National Institute of Mental Health and Neurosciences