HealthyNCT00028197
Comparison of Externally and Self-Initiated 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 voluntary movements triggered by an external stimulus or self-initiated. Registered HCMS healthy normal volunteers may participate. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Nov 2005
- 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
- Normal volunteers will be included. Normal volunteers will be recruited from people who are registered as HMCS Normal Volunteers. All subjects participating in MR studies should have a valid Clinical Center Medical Record Number.
Who cannot join
- 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 prior to functional MRI scan. If the result from a urine pregnancy test is not available for some reason, a medical doctor will judge based on the proper information prior to the scanning.
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
This study will use magnetic resonance imaging (MRI) to investigate how the brain controls voluntary movements triggered by an external stimulus or self-initiated.
Registered HCMS healthy normal volunteers may participate. They will complete a questionnaire and will have a medical history and brief physical examination.
Read more
The study consists of two parts: 1) body movement training and 2) magnetic resonance imaging, as follows:
Part 1 - Body movement training
Participants will train to do three different body movements involving the hands and feet. The movements will either be self-initiated or in response to a stimulus, such as a visual or auditory trigger.
Part 2 - Magnetic resonance imaging
Participants will do one or more of the trained movements, with or without a triggering stimulus, during MRI scanning. MRI is a diagnostic procedure that uses a magnetic field and radio waves to produce images of brain structure and activity. For the procedure, 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. A device compatible with magnetic resonance will be used to record the participant's body movements. The participant may be asked to push buttons of the device during the tasks.
Read the detailed description
Voluntary movements are divided into two categories, one is externally triggered movement and the other is self-initiated movement. The underlying neural mechanisms in each movement have been investigated, but they are not fully understood. The present study is aimed to understand the neural mechanisms, especially aimed to find out the commonly devoted brain area for the categorized movements. By obtaining functional magnetic resonance imaging (fMRI) signals during triggered movement tasks designed from 3 input triggers of different modalities (visual, auditory, and somatosensory) and 3 output movements of different body parts (right hand, left hand, and right foot), we will determine the brain regions specially devoted for each input or output, and commonly devoted for triggered movements. By obtaining fMRI signals during spontaneous voluntary movement tasks designed from 3 output movements of the same body parts, we will determine the brain regions specially devoted for specific execution and commonly devoted for the voluntarily chosen movements.
- Conditions
- Healthy
- Keywords
- Voluntary Movement, Functional MRI, Sensorimotor Integration, Superior Parietal Lobe, Supplementary Motor Area, Normal Control, HV, Healthy Volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2001 (estimated)
- Study startDec 2001
- Study completionNov 2005
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
- 55 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028197
- Sponsor's protocol ID
- 020068
- Other IDs
- 02-N-0068
- Status last verified
- Nov 2005
- First submitted
- 17 Dec 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Alexander GE, Crutcher MD. Neural representations of the target (goal) of visually guided arm movements in three motor areas of the monkey. J Neurophysiol. 1990 Jul;64(1):164-78. doi: 10.1152/jn.1990.64.1.164.
PubMed 2388063Brinkman C, Porter R. Supplementary motor area and premotor area of monkey cerebral cortex: functional organization and activities of single neurons during performance of a learned movement. Adv Neurol. 1983;39:393-420.
PubMed 6419554Burbaud P, Doegle C, Gross C, Bioulac B. A quantitative study of neuronal discharge in areas 5, 2, and 4 of the monkey during fast arm movements. J Neurophysiol. 1991 Aug;66(2):429-43. doi: 10.1152/jn.1991.66.2.429.
PubMed 1774580
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
- Comparison of Externally and Self-Initiated Movements
- ClinicalTrials.gov ID
- NCT00028197
- Acronym / sponsor ID
- 020068
- Conditions
- Healthy
- Keywords
- Voluntary Movement, Functional MRI, Sensorimotor Integration, Superior Parietal Lobe, Supplementary Motor Area, Normal Control, HV, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Dec 2001
- Study completion
- Nov 2005
- First posted
- 18 Dec 2001 (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 voluntary movements triggered by an external stimulus or self-initiated.
Registered HCMS healthy normal volunteers may participate. They will complete a questionnaire and will have a medical history and brief physical examination.
The study consists of two parts: 1) body movement training and 2) magnetic resonance imaging, as follows:
Part 1 - Body movement training
Participants will train to do three different body movements involving the hands and feet. The movements will either be self-initiated or in response to a stimulus, such as a visual or auditory trigger.
Part 2 - Magnetic resonance imaging
Participants will do one or more of the trained movements, with or without a triggering stimulus, during MRI scanning. MRI is a diagnostic procedure that uses a magnetic field and radio waves to produce images of brain structure and activity. For the procedure, 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. A device compatible with magnetic resonance will be used to record the participant's body movements. The participant may be asked to push buttons of the device during the tasks.
Detailed description
Voluntary movements are divided into two categories, one is externally triggered movement and the other is self-initiated movement. The underlying neural mechanisms in each movement have been investigated, but they are not fully understood. The present study is aimed to understand the neural mechanisms, especially aimed to find out the commonly devoted brain area for the categorized movements. By obtaining functional magnetic resonance imaging (fMRI) signals during triggered movement tasks designed from 3 input triggers of different modalities (visual, auditory, and somatosensory) and 3 output movements of different body parts (right hand, left hand, and right foot), we will determine the brain regions specially devoted for each input or output, and commonly devoted for triggered movements. By obtaining fMRI signals during spontaneous voluntary movement tasks designed from 3 output movements of the same body parts, we will determine the brain regions specially devoted for specific execution and commonly devoted for the voluntarily chosen movements.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Normal volunteers will be included. Normal volunteers will be recruited from people who are registered as HMCS Normal Volunteers. All subjects participating in MR studies should have a valid Clinical Center Medical Record Number.
Key exclusion criteria (1 listed)
- 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 prior to functional MRI scan. If the result from a urine pregnancy test is not available for some reason, a medical doctor will judge based on the proper information prior to the scanning.
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 2388063Alexander GE, Crutcher MD. Neural representations of the target (goal) of visually guided arm movements in three motor areas of the monkey. J Neurophysiol. 1990 Jul;64(1):164-78. doi: 10.1152/jn.1990.64.1.164.
- Background: PubMed 6419554Brinkman C, Porter R. Supplementary motor area and premotor area of monkey cerebral cortex: functional organization and activities of single neurons during performance of a learned movement. Adv Neurol. 1983;39:393-420.
- Background: PubMed 1774580Burbaud P, Doegle C, Gross C, Bioulac B. A quantitative study of neuronal discharge in areas 5, 2, and 4 of the monkey during fast arm movements. J Neurophysiol. 1991 Aug;66(2):429-43. doi: 10.1152/jn.1991.66.2.429.
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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 1 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 NCT00028197, 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.