NCT00001783

Brief Summary

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. 1.Patients receiving dextroamphetamine and routine Rehabilitation Medicine
  2. 2.Patients receiving a placebo "sugar pill" and routine Rehabilitation Medicine

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

June 1, 2004

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Cerebrovascular AccidentParalysis

Keywords

RehabilitationPlasticityStrokeAmphetamineMotorHemipareticThromboembolic Non-Hemorrhagic Infarction

Interventions

0-15 WaterDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Feeney DM, Gonzalez A, Law WA. Amphetamine, haloperidol, and experience interact to affect rate of recovery after motor cortex injury. Science. 1982 Aug 27;217(4562):855-7. doi: 10.1126/science.7100929.

    PMID: 7100929BACKGROUND

  • Crisostomo EA, Duncan PW, Propst M, Dawson DV, Davis JN. Evidence that amphetamine with physical therapy promotes recovery of motor function in stroke patients. Ann Neurol. 1988 Jan;23(1):94-7. doi: 10.1002/ana.410230117.

    PMID: 3345072BACKGROUND

  • Walker-Batson D, Smith P, Curtis S, Unwin H, Greenlee R. Amphetamine paired with physical therapy accelerates motor recovery after stroke. Further evidence. Stroke. 1995 Dec;26(12):2254-9. doi: 10.1161/01.str.26.12.2254.

    PMID: 7491646BACKGROUND

MeSH Terms

Conditions

StrokeParalysis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

April 1, 1998

Study Completion

June 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-06

Locations

US(1)