Abstract
The phase-II modafinil in debilitating fatigue after stroke trial demonstrated that modafinil improves fatigue and quality of life in severely fatigued stroke survivors. For this study, we sought to examine the interaction between fatigue and quality of life after stroke and determine whether reducing fatigue resulted in improved quality of life. In addition, we followed up a subset of patients 12-months after the trial to assess the long-term outcomes of modafinil therapy. We used linear regression to analyze interaction between baseline fatigue, as measured by the multidimensional fatigue inventory (MFI), and quality of life, as measured by the stroke-specific quality of life scale (SSQoL); and between changes in MFI and SSQoL during treatment. Patients also took part in semi-structured interviews and study assessments 12-months after trial completion to assess long-term patterns of modafinil use, safety and efficacy. MFI and SSQoL were significantly correlated at baseline (β = -1.975 95% CI -3.082, -0.869, p < 0.001), as were changes in MFI and SSQoL during treatment (β = -1.054 95% CI -1.556, -0.553, p < 0.001). 18 patients agreed to 12-month follow-up, of whom 5 had continued to use modafinil. Patients taking modafinil daily demonstrated sustained improvement of 33-38 points in MFI compared to baseline. Two adverse events were reported and there was no evidence of drug tolerance. Modafinil appears to be safe and, for at least some patients, effective long-term in fatigued stroke survivors. Alleviating fatigue has a significant relationship with improved quality of life. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268, unique-identifier: ACTRN12615000350527.
Highlights
40% of stroke survivors experience debilitating fatigue 3 months or more after their stroke which can negatively impact their quality of life, interfering with their ability to participate in rehabilitation and return to everyday activities such as work and socialization [1]
The change in the total strokespecific quality of life scale (SSQoL) score was associated with the change in multidimensional fatigue inventory (MFI) during modafinil treatment periods, with each 1-point decrease in the MFI corresponding to an improvement of approximately 1-point in the SSQoL (Table 1)
The fact that fatigue was significantly correlated with quality of life at baseline, as well as after treatment, suggests that the improvement in quality of life experienced by patients during the modafinil in debilitating fatigue after stroke (MIDAS) trial was, at least in part, a direct result of alleviating fatigue
Summary
40% of stroke survivors experience debilitating fatigue 3 months or more after their stroke which can negatively impact their quality of life, interfering with their ability to participate in rehabilitation and return to everyday activities such as work and socialization [1]. We recently investigated the effectiveness of the wakefulness-promoting agent modafinil in stroke survivors as part of the modafinil in debilitating fatigue after stroke (MIDAS) trial [2]. During MIDAS, participants reported a significant decrease in fatigue following 6 weeks of modafinil therapy (200 mg/day) and a concurrent improvement in self-reported quality of life. Following from the success of the MIDAS trial, we sought to identify if there was a significant relationship between the resolution of fatigue and improved quality of life during the trial and follow-up patients 12 months after the trial to identify if the reported improved quality of life was sustained 12 months after completion of trial participation. The phase-II modafinil in debilitating fatigue after stroke trial demonstrated that modafinil improves fatigue and quality of life in severely fatigued stroke survivors. We followed up a subset of patients 12-months after the trial to assess the long-term outcomes of modafinil therapy
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