Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

Burke Rehabilitation Hospital

Status and phase: Completed; Phase 2

Conditions: Cerebrovascular Accident; Stroke; Hemiparesis

Treatments: Drug: Armodafinil; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01896128

BRC-394

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

Armodafinil

Experimental group

Description:

150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days

Treatment:

Drug: Armodafinil

Placebo

Placebo Comparator group

Description:

inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days

Treatment:

Drug: Placebo