Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 8:15 AM
Study NCT ID:
NCT00363792
Status:
UNKNOWN
Last Update Posted:
2006-08-15
First Post:
2006-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of GTN and Diamox Measured by BOLD-Response.
Sponsor:
Danish Headache Center
Organization:
Study Overview
Official Title:
The Effect of Glyceryl Trinitrate and Diamox on Blood-Oxygenation-Level-Dependent.Signal (BOLD-Signal) and Cerebral Haemodynamics With the Use of a 3-Tesla MRI-Scan.
Status:
UNKNOWN
Status Verified Date:
2006-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In healthy subjects different cerebral haemodynamic values wished to be determined after infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish to determine are:
* Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
* Changes in the diameter of a. cerebri media.
* Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) method.
* Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
* Changes in the diameter of a. cerebri media.
* Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) method.
Detailed Description:
Experimental headache models give a unike opportunity to study pathophysiological mechanisms of prim. headache types such as migraine. Previous studies have used different methods that have had limitations and none of them have had the opportunity to study neuronal activation. But that is possible with the application of functional magnetic resonance (fMRI).
Before we apply fMRI to our experimental headache models it is needed to determine how the BOLD response is influenced and changed by the infusion of different drugs such as the NO donor Glyceryl Trinitrate (GTN) and Diamox (acetazolamide). It is known that GTN causes dilation of the cerebral arteries without having any effect on the regional cerebral blood flow. It is not known what effect GTN has on the BOLD response. Diamox (azetazolamide) increases the CBF but it is uncertain what effect the drug has on the BOLD response. Previous studies disagree gravely on this point.
In this study we will be giving infusion of GTN and Diamox in healty subjects to determine:
* Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
* Changes in the diameter of a. cerebri media.
* Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) methode.
For the study we will be using a 3-Tesla MRI-scan.
Before we apply fMRI to our experimental headache models it is needed to determine how the BOLD response is influenced and changed by the infusion of different drugs such as the NO donor Glyceryl Trinitrate (GTN) and Diamox (acetazolamide). It is known that GTN causes dilation of the cerebral arteries without having any effect on the regional cerebral blood flow. It is not known what effect GTN has on the BOLD response. Diamox (azetazolamide) increases the CBF but it is uncertain what effect the drug has on the BOLD response. Previous studies disagree gravely on this point.
In this study we will be giving infusion of GTN and Diamox in healty subjects to determine:
* Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
* Changes in the diameter of a. cerebri media.
* Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) methode.
For the study we will be using a 3-Tesla MRI-scan.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: