Modafinil and Exercise for Post Stroke Fatigue

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying ways to help people who feel very tired after having a stroke. Many stroke survivors experience fatigue for a long time, which can make daily activities difficult and reduce their quality of life. The researchers want to find out if two different exercise programs or a medication called Modafinil (compared to a sugar pill) can help improve this fatigue. Additionally, they are interested in seeing if combining Modafinil with exercise offers any extra benefits. The trial will take place across six locations in Canada and will include a range of participants post-stroke.

To be eligible for this study, participants must be over 18 years old, at least three months after their stroke, and experience significant fatigue. They should also be able to walk with minimal assistance. During the trial, participants will be randomly assigned to one of four groups and will follow a treatment plan for eight weeks, which includes taking the medication or sugar pill daily and participating in online exercise sessions three times a week. The researchers will track changes in fatigue, mood, and overall quality of life over six months to determine the best treatment options for post-stroke fatigue.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. \>18 years of age (on date of consent)
• • 2. \>3 months post stroke onset (i.e. intracerebral hemorrhage or ischemic stroke diagnosed by a physician) (on date of consent)
• • 3. evidence of stroke on computed tomography (CT) or magnetic resonance imaging (MRI)
• • 4. disabling post stroke fatigue as measured by Multidimensional Fatigue Inventory score \>60
• • 5. Modified Rankin disability score \<4
• • 6. Able to participate in moderate exercise for an hour (with one person assistance or less)
• • Exclusion Criteria
• • 1. contraindications to Modafinil
• • 2. on stimulant medications already
• • 3. subarachnoid hemorrhage
• • 4. impaired comprehension or language impairment that prevents following visual or pictograph adapted instructions or providing informed consent
• • 5. severe motor impairment or inability to participate in the exercise
• • 6. unable to participate in exercise due to musculoskeletal complaints, unstable heart failure, or renal disease
• • 7. untreated hypothyroidism or anemia
• • 8. cancer likely to result in death in \<6 months
• • 9. severe depression requiring therapy as indicated by suicidal ideation and/or Depression Anxiety Stress Scales (DASS) depression sub-score \>20
• • 10. currently enrolled in a structured exercise program
• • 11. untreated severe sleep apnea with an Apnea/Hypopnea index \>30 as measured by validated wearable sleep apnea detector
• • 12. pregnant, breastfeeding, or positive test for pregnancy at baseline