The MIDAS Trial for Post-Stroke Fatigue
The MIDAS (Modafinil in Debilitating Fatigue After Stroke) trial is a phase II randomized, double-blinded, placebo-controlled crossover trial investigating modafinil 200 mg daily for treating persistent fatigue in ischemic stroke survivors, though this trial is unrelated to myasthenia gravis. 1
Trial Design and Population
The MIDAS trial enrolled stroke survivors with:
- Average score ≥12 across all domains of the Multi-dimensional Fatigue Inventory (MFI-20) 1
- Ischemic stroke diagnosed more than 6 months prior to enrollment 1
- Projected sample size of 36 participants 1
Intervention Protocol
Patients were randomized 1:1 to receive either modafinil 200 mg daily or placebo for 6 weeks, followed by a crossover period where treatments were switched. 1
The trial utilized a single-center, prospective design with three assessment timepoints: baseline, crossover, and study conclusion 1
Outcome Measures
Primary Outcome
- Improvement in fatigue measured by the MFI-20 1
Secondary Outcomes
- Changes in Fatigue Severity Scale scores 1
- Cognitive function assessed using Montreal Cognitive Assessment 1
- Mood changes measured by Depression, Anxiety and Stress Scale 1
- Stroke-specific quality of life scores 1
Neuroimaging Assessments
All participants underwent MRI at three timepoints to measure:
Context Within Post-Stroke Fatigue Research
A 2023 systematic review identified MIDAS as one of only 10 published completed trials (enrolling 616 total participants across all studies) examining pharmacological interventions for post-stroke fatigue, with 5 additional publications reporting secondary analyses of the MIDAS trial specifically. 2
The systematic review concluded that there is currently insufficient evidence to support any particular pharmacological treatment for post-stroke fatigue or to recommend changes in clinical practice. 2
Current Evidence Limitations
- Small sample sizes across all post-stroke fatigue trials 2
- Treatment duration ranging only 28 days to 3 months in published studies 2
- Insufficient data on long-term follow-up outcomes 2
- Most trials measured fatigue only at treatment end, not weeks or months after 2
Important Distinction for Myasthenia Gravis
This MIDAS trial should not be confused with myasthenia gravis management, as it specifically addresses post-stroke fatigue and has no relevance to neuromuscular junction disorders. The evidence provided shows no connection between the MIDAS stroke fatigue trial and myasthenia gravis treatment 1
For myasthenia gravis patients, the standard approach involves pyridostigmine as first-line therapy (30-120 mg orally up to four times daily), with escalation to corticosteroids showing 66-85% positive response rates when needed 3, 4