HealthyNCT00076466
Brain Changes Associated With Learning a Motor Task
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will determine: 1) whether learning a task with the dominant hand is accompanied by changes in the area of the brain that controls hand movement, and 2) how the brain is able to make these changes. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Healthy
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2004to 14 Jan 2009
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Normal volunteers (aged 18 to 40 years) who are willing to participate and who have not participated yet in a protocol using a serial reaction time task (SRRT) and who are not or were not a piano player.
Who cannot join
- Subjects with current use or history of alcohol or drug abuse, psychiatric disorder requiring hospitalization or prolonged treatment, head injury with loss of consciousness, epilepsy, and neurological disease. Subjects receiving drugs acting primarily on the central nervous system.
- The following exclusion criteria are due to the use of trans cranial magnetic stimulation:
- Subjects with cardiac pacemakers, intracardiac lines, implanted medication pumps.
- Subjects with eye, blood vessel, cochlear, or eye implants, subjects with increased intracranial pressure as evaluated by clinical means, subjects with metal in the cranium except in the mouth, subjects with dental braces, metal fragments from occupational exposure or surgical clips in or near the brain.
- Since this protocol utilizes paired pulse stimulation, there is no reason to exclude pregnant women. However, women in the last trimester of pregnancy will not be studied because they will likely be uncomfortable for three hours training.
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: Changes in Intracortical Inhibitory Processes Are Associated With the Development of Implicit Learning of a Motor Task
This study will determine: 1) whether learning a task with the dominant hand is accompanied by changes in the area of the brain that controls hand movement, and 2) how the brain is able to make these changes. Previous studies have shown that practicing a motor task can change brain excitability, but it is not known how well brain excitabilities are changed during motor learning. This study will measure changes in activity of the part of the brain that controls hand movement before, during, and after exercising the hand on a response pad.
Healthy normal volunteers between 18 and 40 years of age may be eligible for this study. Candidates who have not been evaluated at NIH within the past year will be screened with a brief interview about their current state of health and clinical and neurological examinations. Participants will undergo the following procedures:
Read more
Learning a finger movement/reaction time task
For this procedure, participants sit in front of a computer monitor with the index, middle, ring, and little fingers placed flat on four corresponding buttons of a response pad. They are asked to press one of the four buttons as fast as they can in response to an asterisk displayed on the monitor. The position of the asterisk indicates which button to push. Subjects perform nine sets of 120-button pushes with a 15-minute rest between each set. During the rest period, subjects undergo transcranial magnetic stimulation (described below), which causes twitches in the hand muscles. The electrical activity corresponding to the twitches is recorded by attaching electrodes (small metal disks) to the skin over the hand muscles.
Transcranial magnetic stimulation
For this test, an insulated wire coil is held over the scalp. A brief electrical current passes through the coil, creating a magnetic pulse that electrically stimulates the brain. The subject hears a click and may feel a pulling sensation on the scalp under the coil. The stimulation may also cause twitching in the muscles of the face, arm, or leg. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions.
...
Read the detailed description
Objective: We aim to show that the development of implicit knowledge of a motor task is associated with decrease in intracortical GABA-related inhibition (ICI) in the trained muscles (accompanying increasing MEP amplitudes) and increase in ICI in non-trained neighboring muscles and that, after the knowledge becomes explicit, ICI modifications become less prominent.
It would be useful to know the role of ICI during learning. As some interventions or drugs are known to modify GABA activity, this study may even provide a rationale for using these interventions and drugs to enhance plastic changes in patients with impaired motor learning capabilities.
Several studies have shown that learning a motor task with one hand can be transferred to the contralateral hand (37, 43, 45, 46, 47). Studies have demonstrated that learning a finger sequence task (Serial Reaction Time test, SRTT) with the dominant-hand (trained) can be transferred to the contralateral hand (un-trained) (43,49,50). In this additional experiment we propose to investigate the effect of disrupting M1 (by using 1 Hz TMS, inhibitory effect) on motor learning in the trained hand (dominant) and in the un-trained hand (non-dominant). Evidence has shown that there is transcallosal connections between M1 of both hemispheres (40). Since M1 is active during implicit learning (41, 42) we expect 1 Hz TMS stimulation (inhibitory effect) over M1 will deteriorate implicit learning in the trained hand (dominant) as well as in the un-trained hand (non-dominant). This will be evaluated by assessing their effect on reaction times and accuracy of motor performance in both hands.
Study Population: 72 healthy volunteers, aged 18-40 will participate in the study. Subjects will be randomly assigned to either the test session or the control session.
Design: Subjects will complete a unique session. They will perform a serial-reaction-time task. The subjects will be instructed to push a button on a 4-button pad in response to a visual GO signal (which can appear at 4 different positions) using the appropriate digit and the appropriate button. There will be 9 blocks of 120 trials each. In the test group, in blocks 1, 4 and 7 the Go signal appears in a random order; in blocks 2-3, 5-6 and 8-9 the same 12-trial sequence is repeated 10 times. In the control group Go signals will appear in a random order in all blocks. Subjects won't be informed about the sequence but will be asked to notify anything they noticed about the task. If they do notice and report about a sequence they will be considered as having explicit knowledge. Between each block subjects will receive transcranial magnetic stimulations to assess ICI. ICI will be assessed on subjects at rest.
Outcome Measures: Behavioral effect of the motor training will be assessed by measuring the mean reaction times (RT) for digits II and V and the percentage of correct responses for each block.
Implicit learning will be assessed by the difference in RTs between block 3 and 4 and between block 6 and 7. Time at which explicit learning occurs will be assessed by verbal report and the degree of explicit learning by the number of correct items when repeating the sequence.
Implicit learning will be assessed in the trained hand (dominant) (see above) and in the un-trained hand. The un-trained hand will be tested by asking subjects to repeat two random blocks (familiarization) and two sequence blocks. One of these sequence blocks is a repetition of the same sequence that they learned with the dominant hand. The other sequence block is a new sequence containing the same number of characters as the previous sequence. Implicit learning on the un-trained hand will be assessed by the difference in RTs, between random block and the sequence block. In addition, implicit learning on the un-trained hand will be evaluated by testing the difference between the two sequence blocks repeated by the un-trained hand. The time at which explicit learning occurs will be assessed by verbal report and the degree of explicit learning by the number of correct items when repeating the sequence.
Intracortical inhibitory processes will be assessed by measuring the amount of ICI in trained muscles (first dorsal interosseus: FDI and adductor digit minimi: ADM) and a non-trained muscle (opponens pollicis brevis: OPB).
- Conditions
- Healthy
- Keywords
- Brain Excitability, Reaction Time, Plasticity, Motor Evoked Potential, Transcranial Magnetic Stimulation, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2004 (estimated)
- Study start22 Jan 2004
- Study completion14 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 72 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
- NCT00076466
- Sponsor's protocol ID
- 040103
- Other IDs
- 04-N-0103
- Status last verified
- 14 Jan 2009
- First submitted
- 22 Jan 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. doi: 10.1212/wnl.39.3.417.
PubMed 2927652Butefisch CM, Davis BC, Wise SP, Sawaki L, Kopylev L, Classen J, Cohen LG. Mechanisms of use-dependent plasticity in the human motor cortex. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3661-5. doi: 10.1073/pnas.97.7.3661.
PubMed 10716702Classen J, Liepert J, Wise SP, Hallett M, Cohen LG. Rapid plasticity of human cortical movement representation induced by practice. J Neurophysiol. 1998 Feb;79(2):1117-23. doi: 10.1152/jn.1998.79.2.1117.
PubMed 9463469
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
- Changes in Intracortical Inhibitory Processes Are Associated With the Development of Implicit Learning of a Motor Task
- ClinicalTrials.gov ID
- NCT00076466
- Acronym / sponsor ID
- 040103
- Conditions
- Healthy
- Keywords
- Brain Excitability, Reaction Time, Plasticity, Motor Evoked Potential, Transcranial Magnetic Stimulation, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 22 Jan 2004
- Study completion
- 14 Jan 2009
- First posted
- 23 Jan 2004 (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.
This study will determine: 1) whether learning a task with the dominant hand is accompanied by changes in the area of the brain that controls hand movement, and 2) how the brain is able to make these changes. Previous studies have shown that practicing a motor task can change brain excitability, but it is not known how well brain excitabilities are changed during motor learning. This study will measure changes in activity of the part of the brain that controls hand movement before, during, and after exercising the hand on a response pad.
Healthy normal volunteers between 18 and 40 years of age may be eligible for this study. Candidates who have not been evaluated at NIH within the past year will be screened with a brief interview about their current state of health and clinical and neurological examinations. Participants will undergo the following procedures:
Learning a finger movement/reaction time task
For this procedure, participants sit in front of a computer monitor with the index, middle, ring, and little fingers placed flat on four corresponding buttons of a response pad. They are asked to press one of the four buttons as fast as they can in response to an asterisk displayed on the monitor. The position of the asterisk indicates which button to push. Subjects perform nine sets of 120-button pushes with a 15-minute rest between each set. During the rest period, subjects undergo transcranial magnetic stimulation (described below), which causes twitches in the hand muscles. The electrical activity corresponding to the twitches is recorded by attaching electrodes (small metal disks) to the skin over the hand muscles.
Transcranial magnetic stimulation
For this test, an insulated wire coil is held over the scalp. A brief electrical current passes through the coil, creating a magnetic pulse that electrically stimulates the brain. The subject hears a click and may feel a pulling sensation on the scalp under the coil. The stimulation may also cause twitching in the muscles of the face, arm, or leg. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions.
...
Detailed description
Objective: We aim to show that the development of implicit knowledge of a motor task is associated with decrease in intracortical GABA-related inhibition (ICI) in the trained muscles (accompanying increasing MEP amplitudes) and increase in ICI in non-trained neighboring muscles and that, after the knowledge becomes explicit, ICI modifications become less prominent.
It would be useful to know the role of ICI during learning. As some interventions or drugs are known to modify GABA activity, this study may even provide a rationale for using these interventions and drugs to enhance plastic changes in patients with impaired motor learning capabilities.
Several studies have shown that learning a motor task with one hand can be transferred to the contralateral hand (37, 43, 45, 46, 47). Studies have demonstrated that learning a finger sequence task (Serial Reaction Time test, SRTT) with the dominant-hand (trained) can be transferred to the contralateral hand (un-trained) (43,49,50). In this additional experiment we propose to investigate the effect of disrupting M1 (by using 1 Hz TMS, inhibitory effect) on motor learning in the trained hand (dominant) and in the un-trained hand (non-dominant). Evidence has shown that there is transcallosal connections between M1 of both hemispheres (40). Since M1 is active during implicit learning (41, 42) we expect 1 Hz TMS stimulation (inhibitory effect) over M1 will deteriorate implicit learning in the trained hand (dominant) as well as in the un-trained hand (non-dominant). This will be evaluated by assessing their effect on reaction times and accuracy of motor performance in both hands.
Study Population: 72 healthy volunteers, aged 18-40 will participate in the study. Subjects will be randomly assigned to either the test session or the control session.
Design: Subjects will complete a unique session. They will perform a serial-reaction-time task. The subjects will be instructed to push a button on a 4-button pad in response to a visual GO signal (which can appear at 4 different positions) using the appropriate digit and the appropriate button. There will be 9 blocks of 120 trials each. In the test group, in blocks 1, 4 and 7 the Go signal appears in a random order; in blocks 2-3, 5-6 and 8-9 the same 12-trial sequence is repeated 10 times. In the control group Go signals will appear in a random order in all blocks. Subjects won't be informed about the sequence but will be asked to notify anything they noticed about the task. If they do notice and report about a sequence they will be considered as having explicit knowledge. Between each block subjects will receive transcranial magnetic stimulations to assess ICI. ICI will be assessed on subjects at rest.
Outcome Measures: Behavioral effect of the motor training will be assessed by measuring the mean reaction times (RT) for digits II and V and the percentage of correct responses for each block.
Implicit learning will be assessed by the difference in RTs between block 3 and 4 and between block 6 and 7. Time at which explicit learning occurs will be assessed by verbal report and the degree of explicit learning by the number of correct items when repeating the sequence.
Implicit learning will be assessed in the trained hand (dominant) (see above) and in the un-trained hand. The un-trained hand will be tested by asking subjects to repeat two random blocks (familiarization) and two sequence blocks. One of these sequence blocks is a repetition of the same sequence that they learned with the dominant hand. The other sequence block is a new sequence containing the same number of characters as the previous sequence. Implicit learning on the un-trained hand will be assessed by the difference in RTs, between random block and the sequence block. In addition, implicit learning on the un-trained hand will be evaluated by testing the difference between the two sequence blocks repeated by the un-trained hand. The time at which explicit learning occurs will be assessed by verbal report and the degree of explicit learning by the number of correct items when repeating the sequence.
Intracortical inhibitory processes will be assessed by measuring the amount of ICI in trained muscles (first dorsal interosseus: FDI and adductor digit minimi: ADM) and a non-trained muscle (opponens pollicis brevis: OPB).
Study design
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal volunteers (aged 18 to 40 years) who are willing to participate and who have not participated yet in a protocol using a serial reaction time task (SRRT) and who are not or were not a piano player.
Key exclusion criteria (5 listed)
- Subjects with current use or history of alcohol or drug abuse, psychiatric disorder requiring hospitalization or prolonged treatment, head injury with loss of consciousness, epilepsy, and neurological disease. Subjects receiving drugs acting primarily on the central nervous system.
- The following exclusion criteria are due to the use of trans cranial magnetic stimulation:
- Subjects with cardiac pacemakers, intracardiac lines, implanted medication pumps.
- Subjects with eye, blood vessel, cochlear, or eye implants, subjects with increased intracranial pressure as evaluated by clinical means, subjects with metal in the cranium except in the mouth, subjects with dental braces, metal fragments from occupational exposure or surgical clips in or near the brain.
- Since this protocol utilizes paired pulse stimulation, there is no reason to exclude pregnant women. However, women in the last trimester of pregnancy will not be studied because they will likely be uncomfortable for three hours training.
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 2927652Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. doi: 10.1212/wnl.39.3.417.
- Background: PubMed 10716702Butefisch CM, Davis BC, Wise SP, Sawaki L, Kopylev L, Classen J, Cohen LG. Mechanisms of use-dependent plasticity in the human motor cortex. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3661-5. doi: 10.1073/pnas.97.7.3661.
- Background: PubMed 9463469Classen J, Liepert J, Wise SP, Hallett M, Cohen LG. Rapid plasticity of human cortical movement representation induced by practice. J Neurophysiol. 1998 Feb;79(2):1117-23. doi: 10.1152/jn.1998.79.2.1117.
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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 5 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 NCT00076466, which also lists 3 linked publications.
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.