Phase 2
Completed N=19
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
Stroke · Cerebrovascular Accident · Hemiparesis
Source: ClinicalTrials.gov NCT01896128 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100 — 14.8; 12.8; 39.7; 37.8 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100 |
14.8; 12.8; 39.7; 37.8 | — |
| SECONDARY Change in Functional Independence Measure (FIM) From Baseline to Day 100 |
55.5; 52.4; 89.2; 90.9 | — |
| SECONDARY Timed 3-Minute Walk Test From Baseline to Day 100 |
49.4; 152.5; 152.5; 103.3 | — |
| SECONDARY NIH Stroke Scale (NIHSS) |
11.9; 13.4; 6.7; 7.3 | — |
| SECONDARY 9-Hole Peg Test |
34.0; 34.2; 27.3; 29.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01896128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.