Multiple sclerosis
Conditions
Brief summary
Changes in brain function and connectivity measured using resting state fMRI (at baseline and after 3 months of treatment with Modafinil). Functional MRI will be performed at baseline, before and 3h (±30 min) after Modafinil administration, and at the end of treatment (3-month visit).
Detailed description
Changes in brain function and connectivity measured using a Go/no-Go task fMRI., Changes in patient reported outcomes (PROs) and neuropsychological tests - Perceived Deficits Questionnaire (PDQ), Symbol Digit Modalities Test (SDMT), Stroop test measured as interference index, MS-specific QoL questionnaire, Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS) and Modified Fatigue Impact Scale (MFIS). These assessments will occur in the screening or baseline visits and at the end of treatment (3-month visit).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in brain function and connectivity measured using resting state fMRI (at baseline and after 3 months of treatment with Modafinil). Functional MRI will be performed at baseline, before and 3h (±30 min) after Modafinil administration, and at the end of treatment (3-month visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in brain function and connectivity measured using a Go/no-Go task fMRI., Changes in patient reported outcomes (PROs) and neuropsychological tests - Perceived Deficits Questionnaire (PDQ), Symbol Digit Modalities Test (SDMT), Stroop test measured as interference index, MS-specific QoL questionnaire, Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS) and Modified Fatigue Impact Scale (MFIS). These assessments will occur in the screening or baseline visits and at the end of treatment (3-month visit). | — |
Countries
Portugal