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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001783
First Posted: November 4, 1999
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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.


Condition Intervention Phase
Cerebrovascular Accident Paralysis Drug: 0-15 Water Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Neuroanatomical and Neurophysiological Basis of Motor Recovery Associated With Treatment of Recent Stroke Using Amphetamine and Physical Therapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 34
Study Start Date: April 1998
Estimated Study Completion Date: June 2004
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001783


Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001783     History of Changes
Other Study ID Numbers: 980115
98-N-0115
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: March 4, 2008
Last Verified: June 2004

Keywords provided by National Institutes of Health Clinical Center (CC):
Rehabilitation
Plasticity
Stroke
Amphetamine
Motor
Hemiparetic
Thromboembolic Non-Hemorrhagic Infarction

Additional relevant MeSH terms:
Stroke
Paralysis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors