Modafinil and Exercise for Post Stroke Fatigue

Sponsor
University Health Network, Toronto
Study ID
NCT06354985
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Exercise
  • Fatigue
  • Modafinil
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modafinil 200mg — DRUG
    Modafinil 200mg daily for 8 weeks.
  • Placebo — DRUG
    Placebo daily for 8 weeks.
  • Exercise — BEHAVIORAL
    Exercise three times per week for 8 weeks.

Study Details

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.

Key Dates

First listed
Apr 9, 2024
Start date
Sep 30, 2025
Status verified
Jun 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Drug + Exercise
    Placebo Drug + Exercise for 8 weeks.
  • Active Comparator: Modafinil 200 mg/day + Exercise
    Modafinil 200 mg/day + Exercise for 8 weeks.

Primary Outcome Measure

Severity of Fatigue Symptoms [ Time Frame: Week 8 ]

Central Contacts

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