Are you experiencing debilitating fatigue after your stroke? Researchers are trialling a wakefulness drug that could help.
The MIDAS2 study (Modafinil in Debilitating Fatigue After Stroke 2) is looking for people who have severe persisting fatigue after stroke to test the wakefulness medication called modafinil.
A previous study tested modafinil in stroke survivors with debilitating fatigue. They found that 6 weeks of treatment reduced fatigue and improved the quality of life for many trial participants.
This MIDAS 2 study will test whether 200mg of modafinil taken for 56 days is safe and can alleviate stroke-related fatigue in a much larger group of stroke survivors. There are currently hospitals in Newcastle, Melbourne and Adelaide participating in the study. Participants can choose to continue in the study for up to 12 months to test the long-term effectiveness of the drug.
Watch: David, Mark & Tracey & Michelle on their experience with modafinil in the previous MIDAS study
Who can participate in the research?
- People who have had a stroke at least 3 months ago, and
- People who have severe, persistent and debilitating fatigue
Modafinil may not be suitable for people with high levels of anxiety. People with stroke who are pregnant, or planning to become pregnant are not able to participate in this trial. A neurologist will perform a detailed medical assessment to see if you are eligible and whether it is safe for you to participate in the trial.
Why is the research being done?
Fatigue affects up to 70% of stroke survivors. Fatigue has been defined as ‘a feeling of early exhaustion with weariness, lack of energy and aversion to effort that develops during physical or mental activity and is usually not improved by rest'. There are currently no approved medical therapies available for stroke survivors to help manage their fatigue.
What would you be asked to do?
If you’re happy to participate and you meet all of the eligibility criteria , you will be asked to do the following
1) Come to HMRI for 3 visits or undertake online assessments over 3 timepoints over the initial 8-week period. You will be reimbursed for parking costs for these visits. During these appointments, you will be asked to complete surveys, have health assessments (approx. 1-3 hours).
You will be asked for information on your health and function, fatigue levels, quality of life. You will also undergo testing of your current thinking and cognitive skills, fatigue, depression and anxiety.
2) Take tablets every day containing either 200mg modafinil or a placebo (an identical tablet with no active ingredients). There is a ½ or 50% chance of being in the modafinil group and neither you nor the doctors and scientists seeing you as part of the trial will know whether you’re receiving modafinil or placebo. In emergency situations, your study doctor can find out if needed.
You can also choose to take part in any or all of 3 sub-studies:
1) Extra 10 month trial of modafinil
After the first 8 weeks, participants can choose if they want to enrol for a further 10 months. The long-term safety and reliability of modafinil will be studied. There is no placebo arm to this sub-study so all patients who take part will be supplied with modafinil for the 10-month duration.
2) Physical activity monitoring
This will involve wearing a FitBit activity monitor for a period of 1 week during the course of the study.
3) Extra cognitive testing
This involves a more thorough set of cognitive tests at each visit to HMRI and adds approximately 40-60 minutes to each visit.
Click here to download a detailed Participant Information Statement
Researchers: Dr Andrew Bivard, Prof Chris Levi, Prof Neil Spratt, Dr Carlos Garcia-Esperon, Dr Tom Wellings, Dr Shyam Gangadharan, Linda Belevski, Thomas Lillicrap, Prof Michael Nilsson
To find out more or to register your interest please contact Linda Belevski on (02) 4922 3187 or Linda.firstname.lastname@example.org
The study is being supported by The Greater Charitable Foundation.
This study is also inviting people from the Hunter Stroke Research Volunteer Register to participate. To be invited to participate in other studies in stroke rehabilitation and recovery, register here: https://hmri.org.au/stroke-register