CompletedNot Applicable

Learning a Motor Task Through Observation

United States56 participantsStarted 2002-12-23

Plain-language summary

Motor training results in use dependent plasticity (UDP), thought to underlie recovery of motor function after brain injury. The purpose of this protocol is to determine (a) if movement observation results in encoding of a motor memory in the primary motor cortex and (b) if observation of motor training can enhance the effects of physical training in healthy volunteers. If so, this may become an important tool in rehabilitative treatment for patients who are unable or partially able to train. We will test our hypotheses by means of focal single pulse transcranial magnetic stimulation (TMS) in a group of healthy volunteers. Our outcome measure will be the change in TMS-evoked movement direction as a function of training strategy. So far we found that this is the case in healthy volunteers (see data in analysis of the study). The purpose of this amendment is to determine if action observation can elicit the same effects in adult chronic ischemic stroke patients who have had originally significant motor weakness but recovered to the point of being able to perform the motor tasks, possibly resulting in a useful rehabilitative strategy.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA Healthy volunteers and patients with thromboembolic non-hemorrhagic hemispheric lesions at least 6 months after the stroke, aged 18 to 80 years. Patients who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks, and those in whom isolated thumb movements can be evoked by TMS. Handedness will be assessed by the Edinburgh inventory scale. Subjects should be able to sustain attention to the task over 30 minutes. EXCLUSION CRITERIA History of surgery with metallic implants or known history of metallic particles in the eye. Patients with cardiac pacemaker, neural stimulators, cochlear implants, implanted medication pumps. Patients with history of alcohol and drug abuse, psychiatric illness (depression, attention deficit disorder, or dementia). Patients with severe uncontrolled medical problems (e.g. cardiovascular diseases, hypertension, diabetes mellitus, arthritis, active cancer, renal, liver, severe pulmonary diseases, infectious diseases). Patients with epilepsy or history of loss of consciousness. Patients with use of medications that influence synaptic plasticity as evaluated by the investigator, like antipsychotic, antidepressant acting drugs, benzodiazepines. Patients above 80 and less than 18 years of age. Children. Pregnant women in the last trimester. Patients with more than one stroke in the middle cerebral artery te…

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00050869

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

Sponsor typeNIH

Study typeOBSERVATIONAL

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