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| Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001783 |
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;
Patients that have improved motor recovery will undergo neuroimaging and neurophysiological studies to identify areas of the brain involved.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Accident Paralysis |
Drug: 0-15 Water |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| Official Title: | Neuroanatomical and Neurophysiological Basis of Motor Recovery Associated With Treatment of Recent Stroke Using Amphetamine and Physical Therapy |
| Estimated Enrollment: | 34 |
| Study Start Date: | April 1998 |
| Estimated Study Completion Date: | June 2004 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 980115, 98-N-0115 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001783 |
| Health Authority: | United States: Federal Government |
|
Rehabilitation Plasticity Stroke Amphetamine |
Motor Hemiparetic Thromboembolic Non-Hemorrhagic Infarction |
|
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders Paralysis |
Signs and Symptoms Methamphetamine Dopamine Brain Ischemia Neurologic Manifestations Amphetamine Brain Infarction Infarction |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Sympathomimetics Nervous System Diseases Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Autonomic Agents Therapeutic Uses Cardiovascular Diseases Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
