Purpose:
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.
Study summary:
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.
Criteria:
INCLUSION CRITERIA:
Hemiparetic patients (right or left) (defined as a score of 55 or lower on Fugl-Meyer
Scale) who had a single thromboembolic non-hemorrhagic infarction (documented by CT or
MRI) 5 to 30 days before.
Patients will be recruited from referrals from the community particularly from Suburban
Hospital.
EXCLUSION CRITERIA:
Large hemorrhagic or brain stem stroke.
Multiple cerebral lesions with residual deficits.
Less than 5 days after stroke or greater than 30 days after stroke.
Age younger than 18 or older than 80 years.
History of head injury with loss of consciousness.
Terminal illness such as AIDS or cancer.
Severe neurological diseases other than stroke.
History of severe alcohol or drug abuse.
History of psychiatric illness.
Unstable cardiac dysrhythmia or unresponsive arterial hypertension (greater than 160/100
mmHg).
Untreated hyperthyroidism.
Receiving alpha-adrenergic antagonists or agonists.
Receiving major/minor tranquilizers, clonidine, prazosin, phenytoin, GABA,
benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbituates.
Degree of aphasia or cognitive deficit that makes patients unable to give informed
consent.
Pregnancy. A pregnancy test will be done on admission.