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Efficacy and safety of modafinil in post-stroke fatigue: a systematic review and meta-analysis
Iago Nathan Simon Petry1, Gabriel Caruso Novaes Tudella2, Mariana Letícia de Bastos Maximiano3
1Department of Medicine, Universidade do Sul de Santa Catarina, Palhoça, Brazil.
Purpose Of The Research:
Post-stroke fatigue (PSF) is a common and disabling condition that limits rehabilitation and quality of life, yet no pharmacological treatment is well established. Modafinil, a wakefulness-promoting agent, has been proposed as a potential therapy. This systematic review and meta-analysis evaluated its efficacy and safety in PSF.
Principal Results:
Four studies (two RCTs, two observational) comprising 1001 met inclusion criteria. Modafinil did not significantly improve overall fatigue severity on the MFI or FSS. A domain-specific benefit was observed for mental fatigue (MD -2.51; p = 0.0005), with no significant effects on physical, general, or activity-related fatigue. No improvements were found in quality of life (SSQoL) or cognition (MoCA). Modafinil was generally well tolerated with few mild adverse events.
Major Conclusions:
Current evidence does not support modafinil as a routine treatment for PSF. Its effect on mental fatigue is of very low certainty, limiting the strength of this finding. Clinicians should interpret these findings cautiously, and use modafinil only on a case-by-case basis. Larger, high-quality trials with standardized fatigue measures are needed to identify responders and clarify its clinical role.
Insights
Modafinil does not significantly improve overall post-stroke fatigue (PSF), but may help with mental fatigue. More research is needed to confirm its effectiveness and guide clinical use.
Area of Science:
- Neurology
- Pharmacology
- Rehabilitation Medicine
Background:
- Post-stroke fatigue (PSF) is a prevalent and debilitating condition impacting stroke survivors' recovery and quality of life.
- Currently, no established pharmacological treatments exist for managing PSF.
- Modafinil, a medication promoting wakefulness, has been investigated as a potential therapeutic option.
Purpose of the Study:
- To systematically review and meta-analyze the efficacy and safety of modafinil for treating post-stroke fatigue (PSF).
Main Methods:
- A systematic review and meta-analysis were conducted.
- Included studies comprised two randomized controlled trials (RCTs) and two observational studies, totaling 1001 participants.
- Fatigue severity was assessed using the Multidimensional Fatigue Inventory (MFI) and Fatigue Severity Scale (FSS). Quality of life and cognition were measured by the Stroke Specific Quality of Life Scale (SSQoL) and Montreal Cognitive Assessment (MoCA), respectively.
Main Results:
- Modafinil did not demonstrate significant improvements in overall fatigue severity as measured by the MFI or FSS.
- A statistically significant benefit was observed for mental fatigue (MD -2.51; p=0.0005), but not for physical, general, or activity-related fatigue.
- No significant improvements were noted in quality of life (SSQoL) or cognitive function (MoCA).
- Modafinil was generally well-tolerated, with most adverse events reported as mild.
Conclusions:
- The current evidence does not support the routine use of modafinil for treating post-stroke fatigue (PSF).
- The observed effect on mental fatigue is of very low certainty, warranting cautious interpretation.
- Larger, high-quality trials employing standardized fatigue measures are necessary to identify patient subgroups who may respond to modafinil and to define its precise clinical role in PSF management.
