Clinical trial NCT00363792: Effect of GTN and Diamox Measured by BOLD-Response.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Healthy subjects
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

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.

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.

Eligibility criteria: Inclusion Criteria:

* healthy subjects
* age 18-55 years
* weight 50-100 kg

Exclusion Criteria:

* Tension type headache more the once per month.
* other types of headache
* Daily use of medication other the birthcontrol pills.
* Pregnant or lactating women.
* headache on the examination date.
* contraindications to MRI-scan.
* hypotension or hypertension.
* mental illness og substance abuse.
* other significant conditions determined by the examining doctor.

Primary outcomes:
measure: Changes in BOLD response
measure: Changes in a. cerebri media diameter
measure: Changes in CBF
Secondary outcomes:
measure: headache score
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, MD, Phd,
role: STUDY_CHAIR
References: