HealthyNCT00029302
Brain Control of Bimanual (Both Hands) Movements
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 magnetic resonance imaging (MRI) to investigate how the brain controls bimanual movements (movements of both hands). Healthy normal volunteers between 21 and 65 years of age may be eligible for this study. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2001to 24 Dec 2008
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forty normal volunteers ranging from 21 to 75 will be included. Normal volunteers would be recruited from people who are registered as HMCS Normal Volunteers. All subjects should have a valid Clinical Center Medical Record Number.
- Alcohol abstention is required for all subjects for both fMRI and EEG for 24 hours before the study.
Who cannot join
- Normal subjects younger than 21 years and older than 75 will also be excluded from the study since development and decline in movement performance and the associated brain activation is out of the scope of the present study.
- Normal subjects with MRI findings consistent with organic brain lesions such as brain tumors, stroke, trauma or AVMs will be excluded.
- Normal subjects with a history of significant medical disorders such as cancers, or requiring continuous treatment with drugs will be excluded.
- Subjects with mental disorders will be excluded.
- We will not scan pregnant women because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subjects of childbearing potential 24 hours prior to functional MRI scan. Pregnant women will not be excluded from the EEG arm of this protocol.
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: Brain Areas Involved in Temporal Linkage of Bilateral Movements
This study will use magnetic resonance imaging (MRI) to investigate how the brain controls bimanual movements (movements of both hands).
Healthy normal volunteers between 21 and 65 years of age may be eligible for this study.
Read more
Participants will have a medical history, physical and neurological examinations, and will complete a questionnaire before and after testing. The study consists of two parts: 1) finger movement training and 2) magnetic resonance imaging, as follows:
Part 1 - Finger movement training
Participants will train to do three different finger movements using the index finger of both hands. The fingers will be taped to a device that measures their movement. The movements are:
- Lifting and dropping the index fingers of each hand repetitively and in synchrony (starting and stopping at the same time). The amplitude of finger movements is the same for both hands.
- Lifting and dropping the index fingers of each hand repetitively and in synchrony, but with a different amplitude for each hand.
- Lifting and dropping of the index finger of each hand repetitively, but each with a different amplitude and not in synchrony.
Part 2 - Magnetic resonance imaging
Participants will perform the trained movements during MRI scanning. This diagnostic procedure uses a magnetic field and radio waves to produce images of brain structure and activity. For MRI, the subject lies on a stretcher that is moved into the scanner-a cylinder containing a strong magnet. Earplugs are worn to protect the ears from loud thumping noises that occur with electrical switching of radio frequency circuits. Scanning time varies from 20 minutes to 2 hours, with most examinations lasting 1 to 1 1/2 hours. The subject can communicate with the staff person conducting the test at all times during the scan.
Read the detailed description
OBJECTIVE: The present study is aimed to clarify which structure or network of structures are responsible for the temporal linkage in bimanual co-ordination in healthy humans.
STUDY POPULATION: Healthy normal volunteers.
DESIGN:
fMRI: Anatomical MRI and fMRI sequences are performed to obtain blood-oxygenation level-dependent (BOLD) imaging of brain activation during which movement performance will be measured with respect to movement synchrony, movement speed and amplitude.
Multi-channel EEG recording performed while motor performance is monitored.
OUTCOME MEASURES:
fMRI: BOLD will be obtained using baseline correction.
EEG: band-power and inter-regional coherence will be calculated using baseline correction.
- Conditions
- Healthy
- Keywords
- fMRI, Voluntary Movement, Healthy Volunteer, HV, Normal Control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2002 (estimated)
- Study start10 Dec 2001
- Study completion24 Dec 2008
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
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029302
- Sponsor's protocol ID
- 020069
- Other IDs
- 02-N-0069
- Status last verified
- 24 Dec 2008
- First submitted
- 9 Jan 2002
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Ahissar E, Sosnik R, Haidarliu S. Transformation from temporal to rate coding in a somatosensory thalamocortical pathway. Nature. 2000 Jul 20;406(6793):302-6. doi: 10.1038/35018568.
PubMed 10917531Andres FG, Mima T, Schulman AE, Dichgans J, Hallett M, Gerloff C. Functional coupling of human cortical sensorimotor areas during bimanual skill acquisition. Brain. 1999 May;122 ( Pt 5):855-70. doi: 10.1093/brain/122.5.855.
PubMed 10355671Brinkman J, Kuypers HG. Splitbrain monkeys: cerebral control of ipsilateral and contralateral arm, hand, and finger movements. Science. 1972 May 5;176(4034):536-9. doi: 10.1126/science.176.4034.536.
PubMed 4624322
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
- Brain Areas Involved in Temporal Linkage of Bilateral Movements
- ClinicalTrials.gov ID
- NCT00029302
- Acronym / sponsor ID
- 020069
- Conditions
- Healthy
- Keywords
- fMRI, Voluntary Movement, Healthy Volunteer, HV, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 10 Dec 2001
- Study completion
- 24 Dec 2008
- First posted
- 10 Jan 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 magnetic resonance imaging (MRI) to investigate how the brain controls bimanual movements (movements of both hands).
Healthy normal volunteers between 21 and 65 years of age may be eligible for this study.
Participants will have a medical history, physical and neurological examinations, and will complete a questionnaire before and after testing. The study consists of two parts: 1) finger movement training and 2) magnetic resonance imaging, as follows:
Part 1 - Finger movement training
Participants will train to do three different finger movements using the index finger of both hands. The fingers will be taped to a device that measures their movement. The movements are:
- Lifting and dropping the index fingers of each hand repetitively and in synchrony (starting and stopping at the same time). The amplitude of finger movements is the same for both hands.
- Lifting and dropping the index fingers of each hand repetitively and in synchrony, but with a different amplitude for each hand.
- Lifting and dropping of the index finger of each hand repetitively, but each with a different amplitude and not in synchrony.
Part 2 - Magnetic resonance imaging
Participants will perform the trained movements during MRI scanning. This diagnostic procedure uses a magnetic field and radio waves to produce images of brain structure and activity. For MRI, the subject lies on a stretcher that is moved into the scanner-a cylinder containing a strong magnet. Earplugs are worn to protect the ears from loud thumping noises that occur with electrical switching of radio frequency circuits. Scanning time varies from 20 minutes to 2 hours, with most examinations lasting 1 to 1 1/2 hours. The subject can communicate with the staff person conducting the test at all times during the scan.
Detailed description
OBJECTIVE: The present study is aimed to clarify which structure or network of structures are responsible for the temporal linkage in bimanual co-ordination in healthy humans.
STUDY POPULATION: Healthy normal volunteers.
DESIGN:
fMRI: Anatomical MRI and fMRI sequences are performed to obtain blood-oxygenation level-dependent (BOLD) imaging of brain activation during which movement performance will be measured with respect to movement synchrony, movement speed and amplitude.
Multi-channel EEG recording performed while motor performance is monitored.
OUTCOME MEASURES:
fMRI: BOLD will be obtained using baseline correction.
EEG: band-power and inter-regional coherence will be calculated using baseline correction.
Study design
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (5 listed)
- Normal subjects younger than 21 years and older than 75 will also be excluded from the study since development and decline in movement performance and the associated brain activation is out of the scope of the present study.
- Normal subjects with MRI findings consistent with organic brain lesions such as brain tumors, stroke, trauma or AVMs will be excluded.
- Normal subjects with a history of significant medical disorders such as cancers, or requiring continuous treatment with drugs will be excluded.
- Subjects with mental disorders will be excluded.
- We will not scan pregnant women because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subjects of childbearing potential 24 hours prior to functional MRI scan. Pregnant women will not be excluded from the EEG arm of this protocol.
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 10917531Ahissar E, Sosnik R, Haidarliu S. Transformation from temporal to rate coding in a somatosensory thalamocortical pathway. Nature. 2000 Jul 20;406(6793):302-6. doi: 10.1038/35018568.
- Background: PubMed 10355671Andres FG, Mima T, Schulman AE, Dichgans J, Hallett M, Gerloff C. Functional coupling of human cortical sensorimotor areas during bimanual skill acquisition. Brain. 1999 May;122 ( Pt 5):855-70. doi: 10.1093/brain/122.5.855.
- Background: PubMed 4624322Brinkman J, Kuypers HG. Splitbrain monkeys: cerebral control of ipsilateral and contralateral arm, hand, and finger movements. Science. 1972 May 5;176(4034):536-9. doi: 10.1126/science.176.4034.536.
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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 2 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 NCT00029302, 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.