ACTRN12615000350527已完成2 期
For survivors of stroke/TIA experiencing self-reported persistent fatigue, will modafinil be more effective than placebo for reducing self-reported fatigue levels and increasing physical activity levels
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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