Cerebrovascular Accident Clinical Trial
Official title:
Neuroanatomical and Neurophysiological Basis of Motor Recovery Associated With Treatment of Recent Stroke Using Amphetamine and Physical Therapy
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Crisostomo EA, Duncan PW, Propst M, Dawson DV, Davis JN. Evidence that amphetamine with physical therapy promotes recovery of motor function in stroke patients. Ann Neurol. 1988 Jan;23(1):94-7. — View Citation
Feeney DM, Gonzalez A, Law WA. Amphetamine, haloperidol, and experience interact to affect rate of recovery after motor cortex injury. Science. 1982 Aug 27;217(4562):855-7. — View Citation
Walker-Batson D, Smith P, Curtis S, Unwin H, Greenlee R. Amphetamine paired with physical therapy accelerates motor recovery after stroke. Further evidence. Stroke. 1995 Dec;26(12):2254-9. — View Citation
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