Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2008 |
| End Date: | July 2015 |
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
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age less than 18
- Previous clinical stroke
- Pregnant and/or nursing patients
- Major psychiatric history, including psychosis and history of substance abuse
- Dementia
- Known CNS pathology such as brain tumor
- Significant language dysfunction or severe neglect that hinders comprehension,
participation, and barrier to testing
- Seizures
- 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
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