Measuring Blood Flow in the Brain
|First Received Date ICMJE||April 26, 2007|
|Last Updated Date||December 30, 2011|
|Start Date ICMJE||April 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00466934 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Measuring Blood Flow in the Brain|
|Official Title ICMJE||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:
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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||December 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age 18 to 60, inclusive.
|Ages||18 Years to 60 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00466934|
|Other Study ID Numbers ICMJE||070139, 07-N-0139|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP