HealthyNCT00050869
Learning a Motor Task Through Observation
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Healthy
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2002to 15 Nov 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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 territory.
- Patients with bilateral motor impairment.
- Patients with cerebellar or brainstem lesions.
- Patients unable to perform the task (wrist or elbow flexion at least MRC grade 2).
- Patients with unstable cardiac arrhythmia.
- Patients with h/o hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system that lower the seizure threshold or influence synaptic plasticity like neuroleptics, benzodiazepines, tricyclic antidepressants, antiepileptic medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Encoding a Motor Memory by Action Observation
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.
Read the detailed description
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 protocol 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.
- Conditions
- Healthy
- Keywords
- Mirror Neurons, Performance, Use-Dependent Plasticity, Attention, Premotor Cortex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2002 (estimated)
- Study start23 Dec 2002
- Study completion15 Nov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050869
- Sponsor's protocol ID
- 030074
- Other IDs
- 03-N-0074
- Status last verified
- 15 Nov 2007
- First submitted
- 27 Dec 2002
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Strafella AP, Paus T. Modulation of cortical excitability during action observation: a transcranial magnetic stimulation study. Neuroreport. 2000 Jul 14;11(10):2289-92. doi: 10.1097/00001756-200007140-00044.
PubMed 10923687
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encoding a Motor Memory by Action Observation
- ClinicalTrials.gov ID
- NCT00050869
- Acronym / sponsor ID
- 030074
- Conditions
- Healthy
- Keywords
- Mirror Neurons, Performance, Use-Dependent Plasticity, Attention, Premotor Cortex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 23 Dec 2002
- Study completion
- 15 Nov 2007
- First posted
- 30 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 protocol 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.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10923687Strafella AP, Paus T. Modulation of cortical excitability during action observation: a transcranial magnetic stimulation study. Neuroreport. 2000 Jul 14;11(10):2289-92. doi: 10.1097/00001756-200007140-00044.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00050869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.