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Motor Recovery in Recent Stroke Patients Treated With Amphetamine and Physical Therapy
This study has been completed.
Study NCT00001783   Information provided by National Institutes of Health Clinical Center (CC)
First Received: November 3, 1999   Last Updated: March 3, 2008   History of Changes

November 3, 1999
March 3, 2008
April 1998
 
 
 
Complete list of historical versions of study NCT00001783 on ClinicalTrials.gov Archive Site
 
 
 
Motor Recovery in Recent Stroke Patients Treated With Amphetamine and Physical Therapy
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.

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.

Phase II
Interventional
Treatment, Safety/Efficacy Study
  • Cerebrovascular Accident
  • Paralysis
Drug: 0-15 Water
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
34
June 2004
 

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.

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001783
 
980115, 98-N-0115
National Institute of Neurological Disorders and Stroke (NINDS)
 
 
National Institutes of Health Clinical Center (CC)
June 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP