Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

Study Overview
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Brief Summary
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This study is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining attention and faster reaction times. The cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and better physical performances due to a higher level of physical activity.

Official Title
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Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index

Conditions
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Stroke, Post Stroke Fatigue

Intervention / Treatment
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* Drug: modafinil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and stroke within 14 days Modified Rankin Scale 3 or under and Barthel 85 or over before stroke Person that can understand instruction and do tests and questionnaires on their own or with support has given informed consent MFI-20 score of 12 or more Infertile person or fertile women tested negative of pregnancy and using safe anticonception Exclusion Criteria: Dementia or other neuropsychiatric disease making the person incapable of understanding instructions Other disease with fatigue as a known symptom stroke induced by trauma, infection or surgical procedure former drug abuse known contraindication to treatment with modafinil known active malignancy, benign intracranial tumor, subdural or epidural bleeding kidneydysfunction with creatinin more than 265 micromol/L or liver disease with ASAT (aspartate aminotransferase) elevated to more than 70 U/L for women or 100 U/L for men. allergy to project treatment use of benzodiazepin or antiepileptic drugs in a fixed dose. Sleeping pills not included. Patients threaded with ciclosporin or anti HIV medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.<br>|
| Active Comparator: Modafinil<br>Modafinil | Drug: modafinil<br>* Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months<br>* Other names: modiodal, provigil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Fatigue Inventory (MFI- 20) | Questionnaire | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MFI-20 | Questionnaire | 1 month | 
| MFI-20 | Questionnaire | 6 months | 
| Fatigue severity scale (FSS) |  | 3 months | 
| FSS | Questionnaire | 1 month | 
| FSS | Questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, fatigue, modafinil