Interhemispheric InhibitionNCT00295568
Interaction of Right and Left Brain Hemispheres in Learning Precision Hand Movements
An observational study of Interhemispheric Inhibition, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how the two sides of the brain interact when learning precision hand movements. Both sides of the brain are active when a person performs an accurate hand movement. This study will look at the extent to which the two brain hemispheres interact when learning accurate hand movements. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Interhemispheric Inhibition
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2006to 12 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers will be eligible for the study if they are:
- are between the ages of 18-40 years;
- are right-handed;
- are able to perform tasks required by the study;
- are willing and able to give consent
Who cannot join
- Healthy volunteers will not be eligible for the study if they:
- are unable to perform the tasks;
- are left-handed;
- have a history of neurological and psychiatric illness, or of alcohol or drug abuse or severe language disturbances or serious cognitive deficits;
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus, have severe tactile deficits (defined by Frey filaments exerting a force of 4 N to the distal pad of the finger);
- have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, metal in the cranium, with the exception of dental braces.
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: Contribution of Interhemispheric Inhibition to Motor Learning
This study will examine how the two sides of the brain interact when learning precision hand movements. Both sides of the brain are active when a person performs an accurate hand movement. This study will look at the extent to which the two brain hemispheres interact when learning accurate hand movements.
Healthy, right-handed normal volunteers 18 - 40 years of age may be eligible for this study. Candidates are screened with a clinical and neurological examination.
Read more
Participants are randomly assigned to one of two groups - precision or non-precision hand movements. All participants undergo the following procedures:
- Force precision task: Subjects are press a small device between the thumb and index finger. The force produced with the fingertips is translated onto a computer screen. Subjects track a white line passing on the screen with their fingertips.
- Paired-pulse transcranial magnetic stimulation (TMS): A wire coil is held to the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. The effect of paired-pulse TMS on the muscles is detected with electrodes taped to the skin on the arms or legs.
- Surface electromyography (EMG): This test measures the electrical activity of muscles. For this test, electrodes are filled with a gel and taped to the skin over the muscle to be tested.
The study involves six sessions. Sessions 1-5 are on consecutive days; session 6 is one week after session 5.
- Session 1: Familiarization with the motor task and baseline measurements, including error rate, EMG, and paired-pulse TMS
- Session 2: Training in the motor task and repeat measurements as in session 1
- Session 3: Training and measurements as in session 2
- Session 4: Training and measurements as in session 2
- Session 5: Training and measurements as in session 2
- Session 6: Measurements only
Read the detailed description
The purpose of this protocol is to investigate the changes in interhemispheric inhibition (IHI) between human motor cortices with learning of performance of an accurate motor task (pinch force control). Performing a simple motor task is associated with activation in the contralateral motor areas. Activation of the ipsilateral motor/premotor cortex might be elicited by performing more challenging and difficult unimanual motor tasks. However, the functional role played by this ipsilateral activation has been controversial, and is felt to be more prominent with more complex tasks. Several studies using paired-pulse transcranial magnetic stimulation (TMS) revealed a significant IHI from the active upon the non-active hemisphere. Together these results suggested IHI between motor cortical areas may play a critical role in motor control and could influence manual dexterity. Taking these into account, it raises the interesting question of whether the IHI balance between both motor cortices is progressively modified during the learning phase of an accurate motor task. We hypothesize that learning to perform a tracking motor task requiring accurate control of pinch force generation (Tracking accurate), will increase IHI from the "learning" to the "non-learning" hemisphere to a larger extent than learning to perform a less precise tracking motor task (Tracking non-accurate). The primary outcome measure will be the amount of changes in IHI from the "learning" to the "non-learning" hemisphere as a function of learning both motor tasks.
- Conditions
- Interhemispheric Inhibition
- Keywords
- Transcranial Magnetic Stimulation (TMS), Motor Learning, Accuracy, Tracking Motor Task, 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 Feb 2006 (estimated)
- Study start17 Feb 2006
- Study completion12 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 Interhemispheric InhibitionStudies 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
- 46 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295568
- Sponsor's protocol ID
- 060095
- Other IDs
- 06-N-0095
- Status last verified
- 12 Jan 2009
- First submitted
- 23 Feb 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Kim SG, Ashe J, Hendrich K, Ellermann JM, Merkle H, Ugurbil K, Georgopoulos AP. Functional magnetic resonance imaging of motor cortex: hemispheric asymmetry and handedness. Science. 1993 Jul 30;261(5121):615-7. doi: 10.1126/science.8342027.
PubMed 8342027Beltramello A, Cerini R, Puppini G, El-Dalati G, Viola S, Martone E, Cordopatri D, Manfredi M, Aglioti S, Tassinari G. Motor representation of the hand in the human cortex: an f-MRI study with a conventional 1.5 T clinical unit. Ital J Neurol Sci. 1998 Oct;19(5):277-84. doi: 10.1007/BF00713853.
PubMed 10933447Roland PE, Skinhoj E, Lassen NA, Larsen B. Different cortical areas in man in organization of voluntary movements in extrapersonal space. J Neurophysiol. 1980 Jan;43(1):137-50. doi: 10.1152/jn.1980.43.1.137.
PubMed 7351548
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
- Contribution of Interhemispheric Inhibition to Motor Learning
- ClinicalTrials.gov ID
- NCT00295568
- Acronym / sponsor ID
- 060095
- Conditions
- Interhemispheric Inhibition
- Keywords
- Transcranial Magnetic Stimulation (TMS), Motor Learning, Accuracy, Tracking Motor Task, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 17 Feb 2006
- Study completion
- 12 Jan 2009
- First posted
- 23 Feb 2006 (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 examine how the two sides of the brain interact when learning precision hand movements. Both sides of the brain are active when a person performs an accurate hand movement. This study will look at the extent to which the two brain hemispheres interact when learning accurate hand movements.
Healthy, right-handed normal volunteers 18 - 40 years of age may be eligible for this study. Candidates are screened with a clinical and neurological examination.
Participants are randomly assigned to one of two groups - precision or non-precision hand movements. All participants undergo the following procedures:
- Force precision task: Subjects are press a small device between the thumb and index finger. The force produced with the fingertips is translated onto a computer screen. Subjects track a white line passing on the screen with their fingertips.
- Paired-pulse transcranial magnetic stimulation (TMS): A wire coil is held to the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. The effect of paired-pulse TMS on the muscles is detected with electrodes taped to the skin on the arms or legs.
- Surface electromyography (EMG): This test measures the electrical activity of muscles. For this test, electrodes are filled with a gel and taped to the skin over the muscle to be tested.
The study involves six sessions. Sessions 1-5 are on consecutive days; session 6 is one week after session 5.
- Session 1: Familiarization with the motor task and baseline measurements, including error rate, EMG, and paired-pulse TMS
- Session 2: Training in the motor task and repeat measurements as in session 1
- Session 3: Training and measurements as in session 2
- Session 4: Training and measurements as in session 2
- Session 5: Training and measurements as in session 2
- Session 6: Measurements only
Detailed description
The purpose of this protocol is to investigate the changes in interhemispheric inhibition (IHI) between human motor cortices with learning of performance of an accurate motor task (pinch force control). Performing a simple motor task is associated with activation in the contralateral motor areas. Activation of the ipsilateral motor/premotor cortex might be elicited by performing more challenging and difficult unimanual motor tasks. However, the functional role played by this ipsilateral activation has been controversial, and is felt to be more prominent with more complex tasks. Several studies using paired-pulse transcranial magnetic stimulation (TMS) revealed a significant IHI from the active upon the non-active hemisphere. Together these results suggested IHI between motor cortical areas may play a critical role in motor control and could influence manual dexterity. Taking these into account, it raises the interesting question of whether the IHI balance between both motor cortices is progressively modified during the learning phase of an accurate motor task. We hypothesize that learning to perform a tracking motor task requiring accurate control of pinch force generation (Tracking accurate), will increase IHI from the "learning" to the "non-learning" hemisphere to a larger extent than learning to perform a less precise tracking motor task (Tracking non-accurate). The primary outcome measure will be the amount of changes in IHI from the "learning" to the "non-learning" hemisphere as a function of learning both motor tasks.
Study design
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- are between the ages of 18-40 years;
- are right-handed;
- are able to perform tasks required by the study;
- are willing and able to give consent
Key exclusion criteria (6 listed)
- are unable to perform the tasks;
- are left-handed;
- have a history of neurological and psychiatric illness, or of alcohol or drug abuse or severe language disturbances or serious cognitive deficits;
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus, have severe tactile deficits (defined by Frey filaments exerting a force of 4 N to the distal pad of the finger);
- have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, metal in the cranium, with the exception of dental braces.
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 8342027Kim SG, Ashe J, Hendrich K, Ellermann JM, Merkle H, Ugurbil K, Georgopoulos AP. Functional magnetic resonance imaging of motor cortex: hemispheric asymmetry and handedness. Science. 1993 Jul 30;261(5121):615-7. doi: 10.1126/science.8342027.
- Background: PubMed 10933447Beltramello A, Cerini R, Puppini G, El-Dalati G, Viola S, Martone E, Cordopatri D, Manfredi M, Aglioti S, Tassinari G. Motor representation of the hand in the human cortex: an f-MRI study with a conventional 1.5 T clinical unit. Ital J Neurol Sci. 1998 Oct;19(5):277-84. doi: 10.1007/BF00713853.
- Background: PubMed 7351548Roland PE, Skinhoj E, Lassen NA, Larsen B. Different cortical areas in man in organization of voluntary movements in extrapersonal space. J Neurophysiol. 1980 Jan;43(1):137-50. doi: 10.1152/jn.1980.43.1.137.
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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 Interhemispheric Inhibition, 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 5 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 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 NCT00295568, 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.