None listed
Conditions
Brief summary
Debilitating Fatigue is a common complaint in survivors of stroke and transient ischaemic attack (TIA) and can persist for years after the acute event, causing lack of physical activity and participation in rehabilitation and socialisation. Currently there are no pharmaceutical agents approved for the treatment of this fatigue. Modafinil has been shown to reduce fatigue in patients suffering other neurological conditions such as MS and Parkinson's disease, and to improve cognition and memory. This study will aim to measure the efficacy of modafinil in survivors of stroke and TIA experiencing self-reported fatigue.
Interventions
Modafinil (a wakefulness-promoting agent) 200mg/day oral for 6 weeks, with a 2 week washout period between active drug and placebo.
Monitoring adherence will be through drug return.
Sponsors
Hunter-New England Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed