NCT06354985Not yet recruitingPhase 3
Modafinil and Exercise for Post Stroke Fatigue
Modafinil and Exercise for Post Stroke Fatigue (MODEX)
Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke. Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has the following aim: 1\. Test if Exercise plus Modafinil is better than Exercise plus a Sugar Pill This study will take place at up to 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels. Participants will be assigned at random (like flipping a coin) to 1 of 2 groups: 1. Sugar Pill plus Exercise 2. Modafinil plus Exercise The treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months. The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- First submitted
- 22 Mar 2024
- Start date
- Sept 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Stroke
- NCT number
- NCT06354985
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 212
- From Sept 2025 to the primary completion date, Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- on stimulant medications already
- severe depression requiring therapy as indicated by suicidal ideation and/or Depression Anxiety Stress Scales (DASS) depression sub-score \>20
Other illness
- subarachnoid hemorrhage
- impaired comprehension or language impairment that prevents following visual or pictograph adapted instructions or providing informed consent
- severe motor impairment or inability to participate in the exercise
- unable to participate in exercise due to musculoskeletal complaints, unstable heart failure, or renal disease
- cancer likely to result in death in \<6 months
Other
- contraindications to Modafinil
- untreated hypothyroidism or anemia
- currently enrolled in a structured exercise program
- untreated severe sleep apnea with an Apnea/Hypopnea index \>30 as measured by validated wearable sleep apnea detector
- pregnant, breastfeeding, or positive test for pregnancy at baseline
Who the study is looking for
- \>18 years of age (on date of consent)
- \>3 months post stroke onset (i.e. intracerebral hemorrhage or ischemic stroke diagnosed by a physician) (on date of consent)
- evidence of stroke on computed tomography (CT) or magnetic resonance imaging (MRI)
- disabling post stroke fatigue as measured by Multidimensional Fatigue Inventory score \>60
- Modified Rankin disability score \<4
- Able to participate in moderate exercise for an hour (with one person assistance or less)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.