NCT Number: NCT00256802
The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
To examine the ability of MRA to measure the effect of GTN on the intra-cranial vascular response during the GTN-induced headache in healthy volunteers.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
The only intra cranial structures innervated by sensory nerves, and therefore a possible source of the headpain are the meninges and the large intracerebral arteries. The dilatation of the cerebral vessels may not be the origin of the head pain per se, but measurements of the intra cerebral vascular bed in the past has proven valuable in the migraine-research, and has helped elucidate the basis for the migraine aura (Olesen, Friberg et al. 1990). The effects of different signal molecules on the intra cerebral vasculature continue to be an important field in the migraine research, in the search for possible pain causing signaling molecules.
Therefore we have set up at study to examine if MR-Angiography (MRA) can be used for monitoring of the vascular response after challenge with the known vasodilator GTN. This drug was chosen because it is well characterized and a large body of evidence from earlier studies could serve as background data (Thomsen 1997).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- healthy volunteers
Exclusion criteria
- history of migraine or any other type of primary headaches; any kind of daily medication (including prophylactic headache therapy but not oral contraceptives); excessive use of analgesics (corresponding to >2 g aspirin/day), pregnancy and all known contraindications for MR-examinations incl. claustrophobia.
Treatment and study plan
Primary outcomes
-
The primary endpoints were the difference between the area under the curve of the MCA area and the difference between the area under the curve of the diameter of the MCA on an active day and on a placebo day recorded over 60 mins.
Secondary outcomes
-
The secondary endpoints were difference in the area under the curve for the relative changes in area in percent deviation from baseline, and the difference in headache response.
Sponsors and collaborators
Lead sponsor
Danish Headache Center
Other
Registry information
Official study title
The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography (MRA) Under Provocation With Glyceryl Trinitrate in Healthy Volunteers.
Important dates
- Study start
- 2004
- Study completion
- 2005
- First posted
- Nov 22, 2005
- Registry last updated
- Apr 1, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Long-term Atogepant in Real-world Practice
NCT07699549
Brain Diseases, Central Nervous System Diseases
Madrid, Spain
View Trial DetailsIntravenous Fluid for Pediatric Migraine in the Emergency Department
NCT01073787
Brain Diseases, Central Nervous System Diseases
Edmonton, Alberta, Canada
View Trial DetailsMind and Body Approaches to Pain Reduction in Youth With Migraine
NCT03472092
Brain Diseases, Central Nervous System Diseases
Cincinnati, Ohio, United States
View Trial DetailsStudy of Two Digital Therapeutics for the Prevention of Episodic Migraine
NCT05853900
Brain Diseases, Central Nervous System Diseases
New York, United States
View Trial Details