Traumatic Brain InjuryNCT00466934
Measuring Blood Flow in the Brain
An observational study of Traumatic Brain Injury and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will test a method of measuring brain blood flow called near infrared spectroscopy (NIRS). It will determine whether NIRS gives the same results as the more commonly used technique, functional magnetic resonance imaging (fMRI). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Healthy
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2007to 29 Dec 2011
- 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
- Age 18 to 60, inclusive.
Who cannot join
- Pregnancy.
- History of hypertension.
- History of any disease of the central nervous system.
- Current use of sedating medication, including antihistamines.
- Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the MRI magnet upon metal objects in the body.
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: Cross-Validating NIRS With fMRI
This study will test a method of measuring brain blood flow called near infrared spectroscopy (NIRS). It will determine whether NIRS gives the same results as the more commonly used technique, functional magnetic resonance imaging (fMRI).
Healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Participants come to the NIH up to six times for experiments using NIRS and fMRI. They do the following tasks while they are undergoing NIRS or fMRI:
Read more
- looking at a computer monitor while a checkerboard pattern changes
- wiggling the toes and moving the fingers
- Reading words on a computer screen and pushing one button if they are plants and another if they are animals.
For NIRS, a frame is placed on the head and held it in place with a metal band. The frame holds sensors that contact the scalp.
For fMRI, the subject lies on a table that can slide in and out of an MRI scanner, a metal cylinder surrounded by a strong magnetic field. fMRI uses a strong magnetic field and radio waves to obtain images of the brain while the subject performs tasks. During the procedure, The subject wears earplugs to muffle the sound of loud knocking noises that occur during scanning.
Read the detailed description
OBJECTIVE: a) to explore the usefulness of Near Infrared Spectroscopy (NIRS) as a means of mapping brain activity, to see whether the results are similar to those of fMRI and b) to see whether spontaneous brain blood flow changes coincide with changes in behavior.
STUDY POPULATION: 50 healthy volunteers.
DESIGN: The study will look for correlations between NIRS and fMRI signal changes in the same subjects. It will also detect relationships between spontaneous blood flow shifts and shifts and changes in cognitive performance. Finally, NIRS will be combined with a frontal lobe activation task to see if blood flow changes can be detected over the hairless skin of the forehead in a simple, standardized manner that might yield a diagnostic test for frontal injury.
OUTCOME MEASURES: Graded changes in blood flow and oxygen, measured with NIRS and fMRI and variations in response time on a word task.
- Conditions
- Traumatic Brain Injury, Healthy
- Keywords
- Cerebral Blood Flow, Cerebral Cortex, Cognition, Optical Imaging, Healthy Volunteer, HV
- Medical subject headings
- Brain Injuries, Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study start24 Apr 2007
- Study completion29 Dec 2011
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 Traumatic Brain InjuryStudies 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
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- United States Department of Defense, National Institutes of Health Clinical Center (CC), Center for Neuroscience and Regenerative Medicine (CNRM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466934
- Sponsor's protocol ID
- 070139
- Other IDs
- 07-N-0139
- Status last verified
- 29 Dec 2011
- First submitted
- 26 Apr 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Benaron DA, Hintz SR, Villringer A, Boas D, Kleinschmidt A, Frahm J, Hirth C, Obrig H, van Houten JC, Kermit EL, Cheong WF, Stevenson DK. Noninvasive functional imaging of human brain using light. J Cereb Blood Flow Metab. 2000 Mar;20(3):469-77. doi: 10.1097/00004647-200003000-00005.
PubMed 10724111Biswal B, Hudetz AG, Yetkin FZ, Haughton VM, Hyde JS. Hypercapnia reversibly suppresses low-frequency fluctuations in the human motor cortex during rest using echo-planar MRI. J Cereb Blood Flow Metab. 1997 Mar;17(3):301-8. doi: 10.1097/00004647-199703000-00007.
PubMed 9119903Biswal B, Yetkin FZ, Haughton VM, Hyde JS. Functional connectivity in the motor cortex of resting human brain using echo-planar MRI. Magn Reson Med. 1995 Oct;34(4):537-41. doi: 10.1002/mrm.1910340409.
PubMed 8524021
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
- Cross-Validating NIRS With fMRI
- ClinicalTrials.gov ID
- NCT00466934
- Acronym / sponsor ID
- 070139
- Conditions
- Traumatic Brain Injury, Healthy
- Keywords
- Cerebral Blood Flow, Cerebral Cortex, Cognition, Optical Imaging, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- United States Department of Defense, National Institutes of Health Clinical Center (CC), Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- 24 Apr 2007
- Study completion
- 29 Dec 2011
- First posted
- 27 Apr 2007 (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 test a method of measuring brain blood flow called near infrared spectroscopy (NIRS). It will determine whether NIRS gives the same results as the more commonly used technique, functional magnetic resonance imaging (fMRI).
Healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Participants come to the NIH up to six times for experiments using NIRS and fMRI. They do the following tasks while they are undergoing NIRS or fMRI:
- looking at a computer monitor while a checkerboard pattern changes
- wiggling the toes and moving the fingers
- Reading words on a computer screen and pushing one button if they are plants and another if they are animals.
For NIRS, a frame is placed on the head and held it in place with a metal band. The frame holds sensors that contact the scalp.
For fMRI, the subject lies on a table that can slide in and out of an MRI scanner, a metal cylinder surrounded by a strong magnetic field. fMRI uses a strong magnetic field and radio waves to obtain images of the brain while the subject performs tasks. During the procedure, The subject wears earplugs to muffle the sound of loud knocking noises that occur during scanning.
Detailed description
OBJECTIVE: a) to explore the usefulness of Near Infrared Spectroscopy (NIRS) as a means of mapping brain activity, to see whether the results are similar to those of fMRI and b) to see whether spontaneous brain blood flow changes coincide with changes in behavior.
STUDY POPULATION: 50 healthy volunteers.
DESIGN: The study will look for correlations between NIRS and fMRI signal changes in the same subjects. It will also detect relationships between spontaneous blood flow shifts and shifts and changes in cognitive performance. Finally, NIRS will be combined with a frontal lobe activation task to see if blood flow changes can be detected over the hairless skin of the forehead in a simple, standardized manner that might yield a diagnostic test for frontal injury.
OUTCOME MEASURES: Graded changes in blood flow and oxygen, measured with NIRS and fMRI and variations in response time on a word task.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18 to 60, inclusive.
Key exclusion criteria (5 listed)
- Pregnancy.
- History of hypertension.
- History of any disease of the central nervous system.
- Current use of sedating medication, including antihistamines.
- Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the MRI magnet upon metal objects in the body.
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 10724111Benaron DA, Hintz SR, Villringer A, Boas D, Kleinschmidt A, Frahm J, Hirth C, Obrig H, van Houten JC, Kermit EL, Cheong WF, Stevenson DK. Noninvasive functional imaging of human brain using light. J Cereb Blood Flow Metab. 2000 Mar;20(3):469-77. doi: 10.1097/00004647-200003000-00005.
- Background: PubMed 9119903Biswal B, Hudetz AG, Yetkin FZ, Haughton VM, Hyde JS. Hypercapnia reversibly suppresses low-frequency fluctuations in the human motor cortex during rest using echo-planar MRI. J Cereb Blood Flow Metab. 1997 Mar;17(3):301-8. doi: 10.1097/00004647-199703000-00007.
- Background: PubMed 8524021Biswal B, Yetkin FZ, Haughton VM, Hyde JS. Functional connectivity in the motor cortex of resting human brain using echo-planar MRI. Magn Reson Med. 1995 Oct;34(4):537-41. doi: 10.1002/mrm.1910340409.
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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 Traumatic Brain Injury and 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 NCT00466934, 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.