Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent
- Registration Number
- NCT01800097
- Lead Sponsor
- Herlev Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo placebo Modafinil modafinil Modafinil
- Primary Outcome Measures
Name Time Method Multidimensional Fatigue Inventory (MFI- 20) 3 months Questionnaire
- Secondary Outcome Measures
Name Time Method MFI-20 6 months Questionnaire
Fatigue severity scale (FSS) 3 months FSS 6 months Questionnaire
Trial Locations
- Locations (1)
Department of Neurology, Herlev Hospital,
🇩🇰Herlev, Denmark