Motor Recovery in Recent Stroke Patients Treated With Amphetamine and Physical Therapy

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to determine if giving amphetamines along with standard rehabilitation speeds motor recovery after a stroke. In addition, if motor recovery is improved, the study will also identify the areas of the brain involved with the recovery.
Researchers will use motor function ratings, PET scans, functional MRI (fMRI), electroencephalographs, and transcranial magnetic stimulation (TMS) to evaluate patients.
Patients participating in the study will be placed in one of two groups;
1. Patients receiving dextroamphetamine and routine Rehabilitation Medicine
2. Patients receiving a placebo "sugar pill" and routine Rehabilitation Medicine
Patients that have improved motor recovery will undergo neuroimaging and neurophysiological studies to identify areas of the brain involved.

Detailed Description

The purpose of this study is to determine if administration of dextroamphetamine (amph) linked with customarily used Rehabilitation Medicine accelerates motor recovery after stroke. Additionally, if motor recovery occurs, this study will allow identification of the brain regions activated in association with this recovery.
Techniques used will include longitudinal rating of motor function, neuro-imaging with positron emission tomography (PET) and functional magnetic resonance tomography (fMRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS). Patients will be assigned to one of the two groups: amph linked with PT, and placebo linked with PT. Every patient will receive the standard of care PT. Motor recovery will be evaluated in the two groups. If motor recovery is accelerated in any of the groups, then neuroimaging and neurophysiological data will allow identification of areas and networks in the brain associated with this recovery.
This is a Phase II study with potential major impact on how stroke patients are treated.

Conditions

Interventions

Trial Design

  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study

Outcomes

Type Measure Time Frame Safety Issue
No outcomes associated with this trial.

Sponsors