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

March 3, 2008 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Neurological Disorders and Stroke (NINDS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Study Completion

June 1, 2004

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

June 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980115
  • 98-N-0115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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