Healthy Clinical Trial
Official title:
Role of Prostaglandins in the Control of Cerebral Blood Flow During Hypercapnia and Functional Activation in Humans
This study will use magnetic resonance imaging (MRI) to examine the role of prostaglandins-a
type of fatty acid with hormone-like actions-in the regulation of brain blood flow. The
results will provide information on how to better use this technique to study brain
function, which, in turn, may lead to a better understanding of certain illnesses and more
effective treatments.
Healthy normal volunteers 18 years of age and older may be eligible for this study.
Participants will fill out a health questionnaire and undergo a history, physical
examination and MRI studies. MRI is a diagnostic tool that uses a strong magnetic field and
radio waves instead of X-rays to show structural and chemical changes in tissues. During the
scanning, the subject lies on a table in a narrow cylinder containing a magnetic field. An
intercom system allows the subject to speak with the staff member performing the study at
all times during the procedure. Four separate studies will be done-two carbon dioxide
inhalation studies and two functional activation studies-as follows:
Carbon dioxide inhalation (indomethacin): This study is done in two parts. In both parts, an
MRI brain scan is done. During the scan, the subject inhales an air mixture containing 6%
carbon dioxide through a facemask or mouthpiece. Blood pressure and heart rate are monitored
during inhalation of the mixture. For the second part of the study, indomethacin-a
non-steroidal anti-inflammatory drug-is injected through a catheter (thin flexible tube) in
an arm vein. Indomethacin inhibits prostaglandin production. Total scan time averages
between 45 and 90 minutes, with a maximum of 2 hours.
Carbon dioxide inhalation (rofecoxib and celecoxib): This study is identical to the one
above, except either rofecoxib or celecoxib is given instead of indomethacin. Both of these
drugs are also non-steroidal anti-inflammatory drugs that inhibit prostaglandin production.
Unlike indomethacin, rofecoxib and celecoxib are given orally instead of through a vein, so,
to allow time for the drug to be absorbed, the second scan is delayed for 2 hours.
Functional activation (indomethacin): This study is done in two parts. In both parts, a MRI
brain scan is done. During the study, the subject performs a simple motor task, such as
finger tapping. For the second part of the study, indomethacin is injected through a
catheter in an arm vein.
Functional activation (rofecoxib and celecoxib): This study is identical to the indomethacin
functional activation study, except either rofecoxib or celecoxib is given instead of
indomethacin. Because they are given orally instead of through a vein, the second scan is
delayed 2 hours to allow time for the drug to be absorbed.
Status | Completed |
Enrollment | 125 |
Est. completion date | December 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: Any healthy normal volunteer above the age of 18 who is capable of giving informed consent. EXCLUSION CRITERIA: Subjects will be excluded for the following reasons. They have contraindications to MR scanning, such as the following: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump. They have panic disorder or migraine (because of possible complications with CO2 inhalation). They have cirrhosis, any renal dysfunction, or a chronic respiratory illness (such as asthma). They have allergies to sulfonamide drugs or cyclo-oxygenase inhibitors (NSAIDS). |
N/A
Country | Name | City | State |
---|---|---|---|
United States | Warren G. Magnuson Clinical Center (CC) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Kaufmann WE, Worley PF, Pegg J, Bremer M, Isakson P. COX-2, a synaptically induced enzyme, is expressed by excitatory neurons at postsynaptic sites in rat cerebral cortex. Proc Natl Acad Sci U S A. 1996 Mar 19;93(6):2317-21. — View Citation
O'Banion MK. Cyclooxygenase-2: molecular biology, pharmacology, and neurobiology. Crit Rev Neurobiol. 1999;13(1):45-82. Review. — View Citation
Yamagata K, Andreasson KI, Kaufmann WE, Barnes CA, Worley PF. Expression of a mitogen-inducible cyclooxygenase in brain neurons: regulation by synaptic activity and glucocorticoids. Neuron. 1993 Aug;11(2):371-86. — View Citation
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