Clinical trial NCT01896128: Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Cerebrovascular Accident
Hemiparesis
Keywords: stroke
CVA
cerebrovascular accident
hemiparesis
impairment
motor recovery
neuroplasticity
nuvigil
armodafinil
Lead sponsor: Burke Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2013-07-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
timeFrame: Baseline to Day 100
Secondary outcomes:
measure: Change in Functional Independence Measure (FIM) From Baseline to Day 100
timeFrame: Day 100
measure: Timed 3-Minute Walk Test From Baseline to Day 100
timeFrame: Day 1, Day 100
measure: NIH Stroke Scale (NIHSS)
timeFrame: Baseline Day 100
measure: 9-Hole Peg Test
timeFrame: Baseline & Day 100
Other outcomes:
Locations:
city: White Plains
country: United States
facility: The Burke Rehabilitation Hospital
state: New York
Study officials:
affiliation: The Burke Rehabilitation Hospital
name: Pasquale Fonzetti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: