HealthyNCT00046215
Transcranial Magnetic Stimulation to Study Imagination of Movement
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 use transcranial magnetic stimulation (TMS) to examine the relationship between cognitive processing and motor control by determining whether a part of the brain called the premotor cortex is essential to imagining movement. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Nov 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- We will only recruit right-handed subjects as assessed by Edinburgh handedness inventory (Oldfield, 1971). We will also administer a simple version of the tapping task and assess their dexterity to select subjects consistent with the digit skills required.
Who cannot join
- Contraindications for TMS: pacemakers, implanted medical pumps, metal plate in skull, metal objects inside the eye or skull, history of seizures.
- Contraindications for MRI: pacemakers, brain stimulators, dental implants or metallic braces, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, insulin pump, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware. Subjects will be screened for these contraindications prior to the study.
- Subjects with previous or current neuropsychiatric disorders will be excluded. Patients with MRI findings consistent with organic brain lesions such as brain tumors, stroke, or trauma will be excluded. Patients with a history of significant medical disorders such as cancers will be excluded. Subjects not capable of giving informed consent will be excluded.
- We will not scan pregnant women with MRI because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subject of childbearing potential prior to MRI scan.
- Brain functions at a development stage are out of scope of this particular experiment, and, therefore, subjects under age 21 will be excluded.
- Subjects who show evidence of unusually increased cortical excitability that may lead to seizure activity detected by surface EMG recording will be excluded from the study. Subjects who always reveal muscle activity during the motor imagery task will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Effect of Transcranial Magnetic Stimulation to Dorsal Premotor Cortex on Motor Imagination
This study will use transcranial magnetic stimulation (TMS) to examine the relationship between cognitive processing and motor control by determining whether a part of the brain called the premotor cortex is essential to imagining movement. TMS, described below, is a method of brain stimulation that can temporarily inhibit brain functions of the area underlying the stimulator.
Healthy right-handed normal volunteers may be eligible for this study. Candidates will be screened with a medical history, neurological examination, and test of finger dexterity.
Read more
Participants will perform a sequential finger tapping movement in response to a series of numbers (stimuli) displayed on a computer monitor. After 10 stimuli, they will be asked which finger they tapped last. They will then imagine the same finger tapping movement and will be asked which finger they tapped last in their imagination. During these exercises, participants will undergo transcranial magnetic stimulation. For this procedure, the subject is seated comfortably in a chair. A wire coil is placed on the scalp and a brief electrical current is passed through the coil, creating a magnetic pulse that passes into the brain. This generates a very small electrical current in the brain, which briefly disrupts the function of the brain cells in the stimulated area. The stimulation may cause twitching in arm or leg muscles. During the stimulation, the electrical activity of muscles is recorded with a computer or other recording device, using electrodes attached to the skin with tape.
Subjects will complete eight experimental blocks of testing. One block consists of 20 experimental trials, with each trial lasting about 10 seconds. Five pairs of TMS stimuli are given per trial, with pulses delivered in short bursts of one second each. After each block, subjects draw a mark on a line on paper, showing how much attention they are paying, how much fatigue they are experiencing, and how well they think they are executing the tasks. Each TMS session takes up to 3.5 hours.
Before the TMS session, participants will undergo magnetic resonance imaging (MRI) for use in determining proper placement of the TMS coil. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. For this procedure, the subject lies still in a narrow metal cylinder (the scanner) for about 30 minutes during the scan.
Read the detailed description
A high-level of motor control often requires complex processing of sensory information, which likely corresponds to the neural correlates for mental imagery of movement. Such cognitive aspects of motor control may underlie other cognitive functions, such as mental calculation. The present transcranial magnetic stimulation (TMS) study is aimed to characterize the relation between cognitive processing and motor control. Based on our previous results from neuroimaging experiments, we hypothesize that the ability to process information for motor imagery would primarily be associated with the dorsal lateral premotor context (PMd) as well as the posterior parietal cortex. TMS will be used to disrupt neural processes in the limited brain structures under the coil for a short period of time (virtual lesion study). For this proposal, 15 healthy subjects will perform number-guided motor execution/imagery tasks. Both tasks will be guided by 10 visual number stimuli presented at a rate of 1.0 Hz. For the test TMS stimuli, a paired TMS stimulation will be delivered to either M1 or PMd100 (to) 150 milliseconds after 5 of the visual number stimuli. The frequency of TMS stimulation will be 1.0 Hz on average for a short period of time (10 seconds). Measurement will be accuracy of the task performance under the TMS stimulation as compared with a sham condition. We expect that the TMS stimulation to PMd will interfere with the performance of motor imagery more than the performance of motor execution. The present study will clarify the neural correlates underlying the ability of imagining movement, which is now drawing growing attention in the neuroscience community.
- Conditions
- Healthy
- Keywords
- Virtual Lesion Study, Motor Imagery, Primary Motor Cortex, Motor Inhibition, Motor Execution, Healthy Volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2002 (estimated)
- Study startSep 2002
- Study completionNov 2003
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.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046215
- Sponsor's protocol ID
- 020312
- Other IDs
- 02-N-0312
- Status last verified
- Nov 2003
- First submitted
- 21 Sep 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Catalan MJ, Honda M, Weeks RA, Cohen LG, Hallett M. The functional neuroanatomy of simple and complex sequential finger movements: a PET study. Brain. 1998 Feb;121 ( Pt 2):253-64. doi: 10.1093/brain/121.2.253.
PubMed 9549504Cohen LG, Weeks RA, Sadato N, Celnik P, Ishii K, Hallett M. Period of susceptibility for cross-modal plasticity in the blind. Ann Neurol. 1999 Apr;45(4):451-60. doi: 10.1002/1531-8249(199904)45:43.0.co;2-b.
PubMed 10211469Classen J, Witte OW, Schlaug G, Seitz RJ, Holthausen H, Benecke R. Epileptic seizures triggered directly by focal transcranial magnetic stimulation. Electroencephalogr Clin Neurophysiol. 1995 Jan;94(1):19-25. doi: 10.1016/0013-4694(94)00249-k.
PubMed 7530636
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Magnetic Stimulation to Dorsal Premotor Cortex on Motor Imagination
- ClinicalTrials.gov ID
- NCT00046215
- Acronym / sponsor ID
- 020312
- Conditions
- Healthy
- Keywords
- Virtual Lesion Study, Motor Imagery, Primary Motor Cortex, Motor Inhibition, Motor Execution, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Sep 2002
- Study completion
- Nov 2003
- First posted
- 23 Sep 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.
This study will use transcranial magnetic stimulation (TMS) to examine the relationship between cognitive processing and motor control by determining whether a part of the brain called the premotor cortex is essential to imagining movement. TMS, described below, is a method of brain stimulation that can temporarily inhibit brain functions of the area underlying the stimulator.
Healthy right-handed normal volunteers may be eligible for this study. Candidates will be screened with a medical history, neurological examination, and test of finger dexterity.
Participants will perform a sequential finger tapping movement in response to a series of numbers (stimuli) displayed on a computer monitor. After 10 stimuli, they will be asked which finger they tapped last. They will then imagine the same finger tapping movement and will be asked which finger they tapped last in their imagination. During these exercises, participants will undergo transcranial magnetic stimulation. For this procedure, the subject is seated comfortably in a chair. A wire coil is placed on the scalp and a brief electrical current is passed through the coil, creating a magnetic pulse that passes into the brain. This generates a very small electrical current in the brain, which briefly disrupts the function of the brain cells in the stimulated area. The stimulation may cause twitching in arm or leg muscles. During the stimulation, the electrical activity of muscles is recorded with a computer or other recording device, using electrodes attached to the skin with tape.
Subjects will complete eight experimental blocks of testing. One block consists of 20 experimental trials, with each trial lasting about 10 seconds. Five pairs of TMS stimuli are given per trial, with pulses delivered in short bursts of one second each. After each block, subjects draw a mark on a line on paper, showing how much attention they are paying, how much fatigue they are experiencing, and how well they think they are executing the tasks. Each TMS session takes up to 3.5 hours.
Before the TMS session, participants will undergo magnetic resonance imaging (MRI) for use in determining proper placement of the TMS coil. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. For this procedure, the subject lies still in a narrow metal cylinder (the scanner) for about 30 minutes during the scan.
Detailed description
A high-level of motor control often requires complex processing of sensory information, which likely corresponds to the neural correlates for mental imagery of movement. Such cognitive aspects of motor control may underlie other cognitive functions, such as mental calculation. The present transcranial magnetic stimulation (TMS) study is aimed to characterize the relation between cognitive processing and motor control. Based on our previous results from neuroimaging experiments, we hypothesize that the ability to process information for motor imagery would primarily be associated with the dorsal lateral premotor context (PMd) as well as the posterior parietal cortex. TMS will be used to disrupt neural processes in the limited brain structures under the coil for a short period of time (virtual lesion study). For this proposal, 15 healthy subjects will perform number-guided motor execution/imagery tasks. Both tasks will be guided by 10 visual number stimuli presented at a rate of 1.0 Hz. For the test TMS stimuli, a paired TMS stimulation will be delivered to either M1 or PMd100 (to) 150 milliseconds after 5 of the visual number stimuli. The frequency of TMS stimulation will be 1.0 Hz on average for a short period of time (10 seconds). Measurement will be accuracy of the task performance under the TMS stimulation as compared with a sham condition. We expect that the TMS stimulation to PMd will interfere with the performance of motor imagery more than the performance of motor execution. The present study will clarify the neural correlates underlying the ability of imagining movement, which is now drawing growing attention in the neuroscience community.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- We will only recruit right-handed subjects as assessed by Edinburgh handedness inventory (Oldfield, 1971). We will also administer a simple version of the tapping task and assess their dexterity to select subjects consistent with the digit skills required.
Key exclusion criteria (6 listed)
- Contraindications for TMS: pacemakers, implanted medical pumps, metal plate in skull, metal objects inside the eye or skull, history of seizures.
- Contraindications for MRI: pacemakers, brain stimulators, dental implants or metallic braces, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, insulin pump, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware. Subjects will be screened for these contraindications prior to the study.
- Subjects with previous or current neuropsychiatric disorders will be excluded. Patients with MRI findings consistent with organic brain lesions such as brain tumors, stroke, or trauma will be excluded. Patients with a history of significant medical disorders such as cancers will be excluded. Subjects not capable of giving informed consent will be excluded.
- We will not scan pregnant women with MRI because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subject of childbearing potential prior to MRI scan.
- Brain functions at a development stage are out of scope of this particular experiment, and, therefore, subjects under age 21 will be excluded.
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 4 Mar 2008.
- Background: PubMed 9549504Catalan MJ, Honda M, Weeks RA, Cohen LG, Hallett M. The functional neuroanatomy of simple and complex sequential finger movements: a PET study. Brain. 1998 Feb;121 ( Pt 2):253-64. doi: 10.1093/brain/121.2.253.
- Background: PubMed 10211469Cohen LG, Weeks RA, Sadato N, Celnik P, Ishii K, Hallett M. Period of susceptibility for cross-modal plasticity in the blind. Ann Neurol. 1999 Apr;45(4):451-60. doi: 10.1002/1531-8249(199904)45:43.0.co;2-b.
- Background: PubMed 7530636Classen J, Witte OW, Schlaug G, Seitz RJ, Holthausen H, Benecke R. Epileptic seizures triggered directly by focal transcranial magnetic stimulation. Electroencephalogr Clin Neurophysiol. 1995 Jan;94(1):19-25. doi: 10.1016/0013-4694(94)00249-k.
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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 6 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 4 Mar 2008. 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 NCT00046215, 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 4 Mar 2008.