Multiple sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: Control group: Patients are given Placebo tablet for 12 weeks which is identical in shape and other physical characteristics as well as packaging. Drugs are instructed to be used every
Sponsors
Iranian Center of Neurological Research
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Definite MS diagnosis according to McDonald 2017 criteria Age between 18-60 years SDMT score below the 20th percentile of normative values
Exclusion criteria
Exclusion criteria: History of relapse within 2 months History of seizure/epilepsy History of major depression or psychosis Reluctance to enroll in the study Moderate or higher renal dysfunction (eGFR=< 50mL/min/1.73m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in (SDMT) Symbol Digit Modalities Test score (improvement of equal or greater than 4 points or more than 20% increase compared to baseline score is considered a meaningful change). Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: SDMT test which is scored based on the number of correct answers in 90 seconds. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in California Verbal Learning Test (CVLT) test score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: CVLT test.;Change in Brief Visuospatial Memory Test (BVMT) test score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: BVMT test is performed three times consecutively and the sum of three scores is considered as total BVMT score.;Change in Twelve Item MS Walking Scale (MSWS-12) test score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: MSWS-12 questionnaire.;Timed 25-Foot Walk (T25-FW) test score improvement. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: Timed 25-Foot Walk (T25-FW).;Improvement in 9-Hole Peg Test (9-HPT) score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: 9-Hole Peg Test (9-HPT) is performed twice for each hand and mean of 4 tests is considered total score.;Modified Fatigue Impact Scale (MFIS) score change. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: Modified Fatigue Impact Scale (MFIS) questionnaire.;Change in Insomnia Severity Index (ISI) questionnaire score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: Insomnia Severity Index (ISI) questionnaire.;Change in Hospital Anxiety and Depression Scale (HADS) score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSadra Hbibi Moini
Tehran University of Medical Sciences
Outcome results
None listed