NCT00083642

Brief Summary

This study will determine how people who have had a stroke learn to perform a movement by observation, as compared with people who have not had a stroke. Normally, a person learns a new hand movement automatically by observing the movement performed by others. Improvement with practice also relies on visual feedback. This "observational training" - i.e., the repeated observation of a movement - is sufficient for normal individuals to learn a movement. This study will examine brain activity related to motor learning in stroke patients and in healthy control subjects to see whether stroke patients process visual-motor information the same way normal subjects do. Normal volunteers and stroke patients between 18 and 75 years of age may be eligible for this study. Patients must have had paralysis on one side of the body due to a stroke that occurred at least 3 months before entering the study. Candidates who have not had a recent health screening will have a clinical and neurological examination. Participants undergo the following procedures:

  • Brain magnetic resonance imaging (MRI), if one has not been done recently. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that can slide in and out of the cylindrical scanner and wears earplugs to muffle loud noises caused by switching of magnetic fields. Scanning time varies from 20 minutes to 3 hours, with most sessions lasting 45 to 90 minutes.
  • Task training. The subject practices the task to be performed during functional MRI (see below). The subject makes finger tapping movements, then watches finger movements on a video screen for several minutes, during which time the movie stops from time to time without warning. When the movie stops, the subject must reproduce the last finger movement that appeared on the screen. During this session, the electrical signals of the subject's forearm muscles are recorded at the skin surface. This session lasts up to 3 hours.
  • Functional MRI. The subject undergoes MRI scanning while performing the same tasks done in the training session. This session lasts about 3 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

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

May 25, 2004

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

May 27, 2004

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2008

Completed
Last Updated

July 2, 2017

Status Verified

June 13, 2008

First QC Date

May 27, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

Brain PlasticityFunctional MRIFinger MovementRehabilitationImprovementStrokeMotor RecoveryObservationfMRIHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • We will include PATIENTS:
  • Who are aged 18 to 75,
  • With a single thromboembolic non-hemorrhagic hemispheric lesions,
  • With at least a 3 months period since the stroke,
  • Who initially had a severe motor paresis (below MRC grade 2),
  • Who subsequently recovered to the point that they can perform the motor tasks of this study,
  • With no history of other neurological and psychiatric illness,
  • Who are right-handed (before the stroke history).
  • As a control group, we will include NORMAL VOLUNTEERS,
  • Who are age- and gender matched to stroke PATIENTS,
  • Who can perform the motor tasks of this study,
  • With no history of other neurological and psychiatric illness,
  • Who are right-handed.

You may not qualify if:

  • PATIENTS with more than one stroke in the medial cerebral artery territory.
  • PATIENTS with bilateral motor impairment.
  • PATIENTS with cerebellar or brainstem lesions.
  • PATIENTS and NORMAL VOLUNTEERS unable to perform the task.
  • PATIENTS and NORMAL VOLUNTEERS with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
  • PATIENTS and NORMAL VOLUNTEERS with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others).
  • PATIENTS and NORMAL VOLUNTEERS with increased intracranial pressure (as evaluated by clinical examination).
  • PATIENTS and NORMAL VOLUNTEERS with unstable cardiac arrhythmia.
  • PATIENTS and NORMAL VOLUNTEERS with h/o hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
  • PATIENTS and NORMAL VOLUNTEERS with more than moderate to severe microangiopathy (as assessed by multiple peri-ventricular T2 hyperintensity on the pre-experimental anatomical MRI), polyneuropathy (as assessed by clinical examination), diabetes mellitus (medical record), or ischemic peripheral disease (as assessed by clinical examination).
  • PATIENTS and NORMAL VOLUNTEERS who are or who have been good skilled piano or string instruments players.
  • PATIENTS and NORMAL VOLUNTEERS who is on medication with the potential to influence nervous system function, who has a history of surgery with metallic implants or a known history of metallic particles in the eye, a cardiac pacemaker, intracardiac lines, neural stimulators, cochlear implants.
  • PATIENTS and NORMAL VOLUNTEERS who are pregnant.
  • PATIENTS and NORMAL VOLUNTEERS with significant visual loss/deficits.
  • PATIENTS and NORMAL VOLUNTEERS with MRI contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Byrne RW, Russon AE. Learning by imitation: a hierarchical approach. Behav Brain Sci. 1998 Oct;21(5):667-84; discussion 684-721. doi: 10.1017/s0140525x98001745.

    PMID: 10097023BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 27, 2004

First Posted

May 27, 2004

Study Start

May 25, 2004

Study Completion

June 13, 2008

Last Updated

July 2, 2017

Record last verified: 2008-06-13

Locations