NCT01896128

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Burke Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Cerebrovascular Accident
• Hemiparesis

Interventions

Type	Name	Description
DRUG	Armodafinil
DRUG	Placebo	inactive pill manufactured to mimic Armodafinil 150 mg tablet

Timeline

• Start date: 2008-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-07-11
• Last updated: 2019-11-04
• Results posted: 2019-11-04

Locations

1 site across 1 country: United States