Use of a Wakefulness-Promoting Agent (Armodafinil) Combined With Neuro-rehabilitation to Improve Neurological Recovery and to Reduce the Incidence of Disability in Patients Who Suffered a Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
研究概览
简要总结
Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-related training, armodafinil may accelerate motor recovery in chronic stroke patients.
The primary aim of this study is to determine whether administration of armodafinil during subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by armodafinil and, therefore, will induce an improvement in motor function and better performances on measures of motor control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First clinical stroke, either cerebral infarction or intracerebral hemorrhage
- •Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25
- •Screening Motricity Index score of 0-83
- •Date of stroke onset between 7 to 21 days prior to study inclusion
排除标准
- •Age less than 18
- •Previous clinical stroke
- •Pregnant and/or nursing patients
- •Major psychiatric history, including psychosis and history of substance abuse
- •Known CNS pathology such as brain tumor
- •Significant language dysfunction or severe neglect that hinders comprehension, participation, and barrier to testing
- •Left ventricular hypertrophy (LVH)
- •Mitral valve prolapse (MVP)
- •Severe chronic renal failure or severe hepatic failure
- •History or current use of anti-epileptic medications, psychostimulants, or neuroleptics
- •Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal contraceptives, cyclosporine, or theophylline
研究组 & 干预措施
Armodafinil
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
干预措施: Armodafinil (Drug)
Placebo
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
时间窗: Baseline to Day 100
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. The five domains assessed by Fugl-Meyer scale are: * Motor function (Maximum score in upper limb = 66;Maximum score in lower limb = 34) * Sensory function (Maximum score = 24) * Balance (Maximum score = 14) * Range of motion of joints (Maximum score = 44) * Joint pain (Maximum score = 44)
次要结局
- Change in Functional Independence Measure (FIM) From Baseline to Day 100(Day 100)
- NIH Stroke Scale (NIHSS)(Baseline Day 100)
- Timed 3-Minute Walk Test From Baseline to Day 100(Day 1, Day 100)
- 9-Hole Peg Test(Baseline & Day 100)
研究者
Pasquale Fonzetti, MD, PhD
Associate Director, Memory Evaluation and Treatment Service
Burke Rehabilitation Hospital