Post Stroke Fatigue, Stroke
Conditions
Keywords
stroke, fatigue, modafinil
Brief summary
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.
Interventions
DRUGmodafinil
Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
DRUGplacebo
Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Fatigue Inventory (MFI- 20) | 3 months | Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FSS | 1 month | Questionnaire |
| MFI-20 | 1 month | Questionnaire |
| Fatigue severity scale (FSS) | 3 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Barthel Index | 3 months | score |
| Modified Ranking Scale | 3 months | score |
| Multidimensional Depression Inventory | 3 months | Questionnaire |
| Change in Time up and go and chair to stand test from baseline | 3 months | — |
| Cognitive performance, Montreal Cognitive Assessment(MOCA) | 3 months | test |
| Change in bone mineral density and musclemass from baseline to 6 months | 6 months | DXA-scan |
| Stroke Specific Quality Of Life | 6 months | Questionnaire |
| Change in bone mineral density and musclemass from baseline to 3 months | 3 months | DXA-scans. (dual energy x-ray absorptiometry) |
| Reactiontime | 1 month | A special designed computerprogramme will be used to measure the patients reactiontime. |
| Stroke Specific Quality Of Life (SSQOL) | 3 months | Questionnaire |
Countries
Denmark
Outcome results
None listed