HealthyNCT00034073
Magnetic Resonance Imaging in Children and Adults Using Arterial Spin Tagging Techniques
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 examine how blood flow to the brain differs at different ages with the brain is at rest, and during performance of tasks that involve language, memory, motor control, and sight. Read more about this study
- Who is it for?
- Ages 8 to 50 years
- Conditions the study is for
- Healthy
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2002to 16 Apr 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 8 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Right-handed (Edinburgh Handedness Inventory)
- Native English speaker (for language and memory paradigms only)
Who cannot join
- Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.)
- History of neurologic or psychiatric disease or a learning or attentional disorder
- One year below grade level
- CNS active medications
- Pregnancy
- Claustrophobia
- Inability to comply with the protocol
- Volunteers will also be asked if they have a history of dry or irritated eyes and informed this may increase the risk of eye irritation and discomfort in the 3T scanner.
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: Quantitative fMRI in Children and Adults Using Arterial Spin Tagging Techniques
This study will use magnetic resonance imaging (MRI) to examine how blood flow to the brain differs at different ages with the brain is at rest, and during performance of tasks that involve language, memory, motor control, and sight. The study will evaluate the usefulness of MRI in identifying language function and location, and may provide information on how the brain develops over time to process brain functions, such as language and memory.
Healthy normal volunteers in three age groups-children 8-10, adolescents 13-16, and young adults 21-30-may be eligible for this study. Participants must be right-handed and be native English speakers. Candidates will be screened via a telephone interview and examination by a neurologist.
Participants will undergo MRI scanning of the brain during rest or while performing a task designed to test a skill. The tasks may involve remembering numbers, reading a word, tapping fingers, or looking at a flashing picture. MRI uses a magnetic field and radio waves to produce pictures of the brain. For the procedure, the subject lies still on a table that is moved into the scanner (a cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. Adults may spend as long as 90 minutes in the scanner, usually less than 45 minutes. For children, the time is less than 75 minutes-usually 30 to 40 minutes. Participants may be asked to repeat the scans up to 5 times in different sessions to test different brain functions or confirm findings.
Read the detailed description
FMRI using BOLD technique is an indirect and relative measure of neuronal activity and makes comparison among age groups problematic in light of known age related changes in glucose consumption and resting cerebral blood flow. In this study Arterial Spin Tagging techniques will be used to perform quantitative measures of blood flow changes during fMRI tasks. Children and adults will perform four tasks: primary sensory (photic flash), primary motor (finger tapping), and cognitive (working memory and semantic decision) tasks using parametric block designs, to account for developmental performance, using imaging parameters that allow quantitative measures of cerebral blood flow response as well as BOLD signal. Three age groups will be studied, children 8-10, 14-16, and young adults (21-28). Data will be analyzed using AFNI to identify activated areas. Further analysis will be performed using a region of interest analysis. We will compare quantitative measures at optimal performance levels. The three experimental age groups will be compared for delta rCBF and extent of activated area for each task. The study will determine age dependent changes in blood flow response during cortical activation across ages.
- Conditions
- Healthy
- Keywords
- Imaging, Pediatrics, Brain, Mapping, Development, 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 posted22 Apr 2002 (estimated)
- Study start18 Apr 2002
- Study completion16 Apr 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 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
- 70 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034073
- Sponsor's protocol ID
- 020182
- Other IDs
- 02-N-0182
- Status last verified
- 16 Apr 2009
- First submitted
- 20 Apr 2002
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Barnes PD. Imaging of the central nervous system in pediatrics and adolescence. Pediatr Clin North Am. 1992 Aug;39(4):743-76. doi: 10.1016/s0031-3955(16)38374-2.
PubMed 1635805Braver TS, Cohen JD, Nystrom LE, Jonides J, Smith EE, Noll DC. A parametric study of prefrontal cortex involvement in human working memory. Neuroimage. 1997 Jan;5(1):49-62. doi: 10.1006/nimg.1996.0247.
PubMed 9038284Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
PubMed 1948051
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
- Quantitative fMRI in Children and Adults Using Arterial Spin Tagging Techniques
- ClinicalTrials.gov ID
- NCT00034073
- Acronym / sponsor ID
- 020182
- Conditions
- Healthy
- Keywords
- Imaging, Pediatrics, Brain, Mapping, Development, Healthy Volunteer, HV, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 18 Apr 2002
- Study completion
- 16 Apr 2009
- First posted
- 22 Apr 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 examine how blood flow to the brain differs at different ages with the brain is at rest, and during performance of tasks that involve language, memory, motor control, and sight. The study will evaluate the usefulness of MRI in identifying language function and location, and may provide information on how the brain develops over time to process brain functions, such as language and memory.
Healthy normal volunteers in three age groups-children 8-10, adolescents 13-16, and young adults 21-30-may be eligible for this study. Participants must be right-handed and be native English speakers. Candidates will be screened via a telephone interview and examination by a neurologist.
Participants will undergo MRI scanning of the brain during rest or while performing a task designed to test a skill. The tasks may involve remembering numbers, reading a word, tapping fingers, or looking at a flashing picture. MRI uses a magnetic field and radio waves to produce pictures of the brain. For the procedure, the subject lies still on a table that is moved into the scanner (a cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. Adults may spend as long as 90 minutes in the scanner, usually less than 45 minutes. For children, the time is less than 75 minutes-usually 30 to 40 minutes. Participants may be asked to repeat the scans up to 5 times in different sessions to test different brain functions or confirm findings.
Detailed description
FMRI using BOLD technique is an indirect and relative measure of neuronal activity and makes comparison among age groups problematic in light of known age related changes in glucose consumption and resting cerebral blood flow. In this study Arterial Spin Tagging techniques will be used to perform quantitative measures of blood flow changes during fMRI tasks. Children and adults will perform four tasks: primary sensory (photic flash), primary motor (finger tapping), and cognitive (working memory and semantic decision) tasks using parametric block designs, to account for developmental performance, using imaging parameters that allow quantitative measures of cerebral blood flow response as well as BOLD signal. Three age groups will be studied, children 8-10, 14-16, and young adults (21-28). Data will be analyzed using AFNI to identify activated areas. Further analysis will be performed using a region of interest analysis. We will compare quantitative measures at optimal performance levels. The three experimental age groups will be compared for delta rCBF and extent of activated area for each task. The study will determine age dependent changes in blood flow response during cortical activation across ages.
Study design
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Right-handed (Edinburgh Handedness Inventory)
- Native English speaker (for language and memory paradigms only)
Key exclusion criteria (8 listed)
- Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.)
- History of neurologic or psychiatric disease or a learning or attentional disorder
- One year below grade level
- CNS active medications
- Pregnancy
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 1635805Barnes PD. Imaging of the central nervous system in pediatrics and adolescence. Pediatr Clin North Am. 1992 Aug;39(4):743-76. doi: 10.1016/s0031-3955(16)38374-2.
- Background: PubMed 9038284Braver TS, Cohen JD, Nystrom LE, Jonides J, Smith EE, Noll DC. A parametric study of prefrontal cortex involvement in human working memory. Neuroimage. 1997 Jan;5(1):49-62. doi: 10.1006/nimg.1996.0247.
- Background: PubMed 1948051Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
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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 8 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 NCT00034073, 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.