HealthyNCT00120666
Interhemispheric Plasticity in Humans
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 how the brain controls movements by sending messages to the spinal cord and muscles. Researchers want to know if strengthening a hand muscle will increase the strength of the same muscle in the other hand, and if these changes happen in the brain or spine, or both. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2005to 25 Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female volunteers ages 18-60 years old will qualify for this study. The subject population will be equitable and we will strive to enroll volunteers from all ethnic backgrounds.
Who cannot join
- orthopedic impairments of the upper extremities
- neurological impairments, including current or past peripheral or central nervous system dysfunction
- being on drugs that may lower the seizure threshold
- having a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects in the eye or skull (for example after brain surgery or shrapnel wounds)
- consumption of more than moderate amounts of alcohol or caffeine
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
This study will determine how the brain controls movements by sending messages to the spinal cord and muscles. Researchers want to know if strengthening a hand muscle will increase the strength of the same muscle in the other hand, and if these changes happen in the brain or spine, or both. Plasticity in this study refers to the capacity for continuous changes of the neural pathways in the brain and nervous system. Researchers have seen cases in which using a muscle extensively (force production) in one muscle group has increased the strength of the same muscle group on the opposite side of the body (force transfer). This situation happens without the unused muscle becoming larger-suggesting that the practice causes changes in some parts of the brain or spine. It is vital for scientists to know how this effect works, so that they can create new rehabilitation methods for people who cannot move or who have difficulty moving one side of their body.
Patients ages 18 to 60 who are in good health and who do not have a history of major conditions affecting the bones, joints or nervous system may be eligible for this study. Patients will undergo a medical examination. There will be 1 or 2 testing sessions, 20 training sessions, and 1 or 2 final testing sessions, with patients being asked to come to the laboratory for as few as 4 times (about 10 hours total) or for up to 25 visits (about 20 hours total). The investigator will indicate which of six different groups that a patient is selected for.
Read more
During testing sessions, the strength of the pointer and little fingers in each hand will be determined through the use of very brief electrical pulses. There also will be transcranial magnetic stimulation (TMS) and 1 Hz TMS. The researchers will place one or two wire coils on the patient's scalp and make marks on the scalp which will be removed at the end of the session. During the TMS, a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Patients will hear a click sound and feel a snapping sensation on the skin. They may also feel and see small twitches in the hand muscles, and the fingers or wrist may move. There will be a total of about 300 magnetic stimuli, at a rate of 10 pulses per minute. Patients will also have an electromyogram (EMG), a procedure recording electrical activity in the muscles that are activated by electrical or magnetic stimulation. Metal electrodes will be attached to the skin over the muscle. During the EMG, patients will be asked to tense certain muscles slightly. Depending on the group a patient is assigned to, he or she may be asked to use the right index finger by using voluntary muscle movement, electrical stimulation, his or her imagination, electrical stimulation of a different hand muscle, or voluntary movements immediately followed by repetitive TMS.
Regardless of group assignment, there will be five blocks of 10 repetitions of finger exercise per session, 200 per week, and 1,000 throughout the whole study. During the study sessions, patients will be able to talk and move around. They can take a break and leave the room if needed. In most cases, the session will take less than 2 hours. There also will be a control group whose members will not be training their fingers but who will participate only in the testing sessions. TMS is a safe procedure; however, strong contractions of scalp muscles have been known to cause headaches. Also, because of the distracting noise of the TMS, patients will be fitted with earplugs to wear during the procedure.
Compensation for research-related discomfort and inconvenience will be made to participants, with a maximum of $500 to $600, depending on assignment to groups. This study will not have a direct benefit for participants. However, researchers hope to gain information that will help them better understand how the two sides of the brain control movement and how they affect each other regarding movement control.
Read the detailed description
Strength training of a limb muscle on one side of the body produces functionally and clinically meaningful increases in motor output of the same muscle on the opposite side of the body. Such adaptations occur without muscle hypertrophy, implying a role for the ipsilateral motor cortex and the spinal cord in force transfer. The goal of this project is to determine the interhemispheric and spinal mechanisms of force transfer in healthy young adults. We hypothesize that the effects of unilateral practice on interhemispheric inhibition (IHI) and on the excitability of the contralateral corticospinal projections are linked, and these effects are graded according to the nature of muscle activation. In a series of experiments on healthy adults age 18 to 60, we will characterize the motor cortical inhibitory and excitatory mechanisms of interhemispheric practice-induced transfer of muscle force.
We will use a longitudinal design that will include three exercise groups. In 20 sessions over 4 weeks, subjects will strengthen their first dorsal interosseus (FDI) muscle of the dominant hand either with voluntary, electrically stimulated, or imagined contractions. The design also includes three control groups, a sham-stimulated group, a repetitive transcranial magnetic stimulation (1HzTMS) group, and a no-intervention group. Before and after the training programs, we will determine the changes in the outcome measures, including voluntary and electrical stimulation evoked force of the trained and the untrained FDI. Measures of excitability of the involved and uninvolved motor cortex, assessed with TMS, and measures of spinal cord excitability, assessed with peripheral nerve stimulation, are the additional outcome measures. The results of these studies will substantially increase our understanding of central nervous system (CNS) control of voluntary movement in health and disease.
- Conditions
- Healthy
- Keywords
- Exercise, Stimulation, Nerve, Electrical, Muscle, Healthy Volunteer, HV
- Medical subject headings
- Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study start8 Jul 2005
- Study completion25 Jun 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.
- 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
- 108 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120666
- Sponsor's protocol ID
- 050188
- Other IDs
- 05-N-0188
- Status last verified
- 25 Jun 2007
- First submitted
- 16 Jul 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
ASANUMA H, OKUDA O. Effects of transcallosal volleys on pyramidal tract cell activity of cat. J Neurophysiol. 1962 Mar;25:198-208. doi: 10.1152/jn.1962.25.2.198. No abstract available.
PubMed 13862744
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
- Interhemispheric Plasticity in Humans
- ClinicalTrials.gov ID
- NCT00120666
- Acronym / sponsor ID
- 050188
- Conditions
- Healthy
- Keywords
- Exercise, Stimulation, Nerve, Electrical, Muscle, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 8 Jul 2005
- Study completion
- 25 Jun 2007
- First posted
- 18 Jul 2005 (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 how the brain controls movements by sending messages to the spinal cord and muscles. Researchers want to know if strengthening a hand muscle will increase the strength of the same muscle in the other hand, and if these changes happen in the brain or spine, or both. Plasticity in this study refers to the capacity for continuous changes of the neural pathways in the brain and nervous system. Researchers have seen cases in which using a muscle extensively (force production) in one muscle group has increased the strength of the same muscle group on the opposite side of the body (force transfer). This situation happens without the unused muscle becoming larger-suggesting that the practice causes changes in some parts of the brain or spine. It is vital for scientists to know how this effect works, so that they can create new rehabilitation methods for people who cannot move or who have difficulty moving one side of their body.
Patients ages 18 to 60 who are in good health and who do not have a history of major conditions affecting the bones, joints or nervous system may be eligible for this study. Patients will undergo a medical examination. There will be 1 or 2 testing sessions, 20 training sessions, and 1 or 2 final testing sessions, with patients being asked to come to the laboratory for as few as 4 times (about 10 hours total) or for up to 25 visits (about 20 hours total). The investigator will indicate which of six different groups that a patient is selected for.
During testing sessions, the strength of the pointer and little fingers in each hand will be determined through the use of very brief electrical pulses. There also will be transcranial magnetic stimulation (TMS) and 1 Hz TMS. The researchers will place one or two wire coils on the patient's scalp and make marks on the scalp which will be removed at the end of the session. During the TMS, a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Patients will hear a click sound and feel a snapping sensation on the skin. They may also feel and see small twitches in the hand muscles, and the fingers or wrist may move. There will be a total of about 300 magnetic stimuli, at a rate of 10 pulses per minute. Patients will also have an electromyogram (EMG), a procedure recording electrical activity in the muscles that are activated by electrical or magnetic stimulation. Metal electrodes will be attached to the skin over the muscle. During the EMG, patients will be asked to tense certain muscles slightly. Depending on the group a patient is assigned to, he or she may be asked to use the right index finger by using voluntary muscle movement, electrical stimulation, his or her imagination, electrical stimulation of a different hand muscle, or voluntary movements immediately followed by repetitive TMS.
Regardless of group assignment, there will be five blocks of 10 repetitions of finger exercise per session, 200 per week, and 1,000 throughout the whole study. During the study sessions, patients will be able to talk and move around. They can take a break and leave the room if needed. In most cases, the session will take less than 2 hours. There also will be a control group whose members will not be training their fingers but who will participate only in the testing sessions. TMS is a safe procedure; however, strong contractions of scalp muscles have been known to cause headaches. Also, because of the distracting noise of the TMS, patients will be fitted with earplugs to wear during the procedure.
Compensation for research-related discomfort and inconvenience will be made to participants, with a maximum of $500 to $600, depending on assignment to groups. This study will not have a direct benefit for participants. However, researchers hope to gain information that will help them better understand how the two sides of the brain control movement and how they affect each other regarding movement control.
Detailed description
Strength training of a limb muscle on one side of the body produces functionally and clinically meaningful increases in motor output of the same muscle on the opposite side of the body. Such adaptations occur without muscle hypertrophy, implying a role for the ipsilateral motor cortex and the spinal cord in force transfer. The goal of this project is to determine the interhemispheric and spinal mechanisms of force transfer in healthy young adults. We hypothesize that the effects of unilateral practice on interhemispheric inhibition (IHI) and on the excitability of the contralateral corticospinal projections are linked, and these effects are graded according to the nature of muscle activation. In a series of experiments on healthy adults age 18 to 60, we will characterize the motor cortical inhibitory and excitatory mechanisms of interhemispheric practice-induced transfer of muscle force.
We will use a longitudinal design that will include three exercise groups. In 20 sessions over 4 weeks, subjects will strengthen their first dorsal interosseus (FDI) muscle of the dominant hand either with voluntary, electrically stimulated, or imagined contractions. The design also includes three control groups, a sham-stimulated group, a repetitive transcranial magnetic stimulation (1HzTMS) group, and a no-intervention group. Before and after the training programs, we will determine the changes in the outcome measures, including voluntary and electrical stimulation evoked force of the trained and the untrained FDI. Measures of excitability of the involved and uninvolved motor cortex, assessed with TMS, and measures of spinal cord excitability, assessed with peripheral nerve stimulation, are the additional outcome measures. The results of these studies will substantially increase our understanding of central nervous system (CNS) control of voluntary movement in health and disease.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female volunteers ages 18-60 years old will qualify for this study. The subject population will be equitable and we will strive to enroll volunteers from all ethnic backgrounds.
Key exclusion criteria (5 listed)
- orthopedic impairments of the upper extremities
- neurological impairments, including current or past peripheral or central nervous system dysfunction
- being on drugs that may lower the seizure threshold
- having a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects in the eye or skull (for example after brain surgery or shrapnel wounds)
- consumption of more than moderate amounts of alcohol or caffeine
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 13862744ASANUMA H, OKUDA O. Effects of transcallosal volleys on pyramidal tract cell activity of cat. J Neurophysiol. 1962 Mar;25:198-208. doi: 10.1152/jn.1962.25.2.198. No abstract available.
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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 NCT00120666, 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.