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

Completed · Phase 2

Conditions studied: Cerebrovascular Accident, Paralysis

In brief

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.

Key facts

Study ID

NCT00001783

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

34

Starts

1998-04-01

Expected to finish

2004-06-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Institute of Neurological Disorders and Stroke (NINDS) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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