Modafinil in debilitating fatigue after stroke
- Conditions
- StrokeTransient Ischaemic AttackStroke - Ischaemic
- Registration Number
- ACTRN12615000350527
- Lead Sponsor
- Hunter-New England Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1: have suffered an ischaemic stroke or TIA at least 3 months ago
2: have persistent self-reported fatigue with MFI-20 score of 12 or more
3: modified Rankin Score (mRS) of 3 or less
4: can speak reasonable English, understand instructions and be able to complete tests and questionnaires on their own or with minimal support
5: able to give informed consent
1: pre-existing depression, dementia or other neuropsychiatric disease
2: other diagnoses with fatigue as a known symptom e.g. chronic fatigue syndrome, multiple sclerosis
3: stroke induced by trauma, infection or surgery
4: current or past drug abuse
5: known contraindication to treatment with modafinil
6: known active malignancy, any intracranial tumor, subdural or epidural hematoma
7: known contraindications to MRI scanning e.g. claustrophobia, pacemaker or other implants
8: renal or hepatic impairment
9: use of benzodiazepines or antiepileptic drugs
10: patients on immunosuppression or known immunodeficiency state e.g. HIV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self-reported fatigue as assessed on the Multi-dimensional Fatigue Inventory (MFI-20). [At the end of each 6-week treatment arm.];Changes in physical activity as determined by the use of wearable monitoring devices (Fitbit HR) which the participant is required to wear during the entire study period. [At the end of each 6-week treatment arm.]
- Secondary Outcome Measures
Name Time Method At the end of each 6-week treatment arm.[At the end of each 6-week treatment arm.];Cognition assessed with the Montreal Cognitive Assessment (MoCA)[At the end of each 6-week treatment arm.];Mood as assessed by the depression, anxiety and stress scale (DASS 42).[At the end of each 6-week treatment arm.];Stroke specific quality of life (SSQOL) score.[At the end of each 6-week treatment arm.];Whole-brain cerebral blood flow as measure by MRI ASL.[At the end of each 6-week treatment arm.]