Effect of GTN and Diamox Measured by BOLD-Response.

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00363792
• Other study ID #: KA-20060085
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2006
• Last updated: August 11, 2006
• Est. completion date: May 2007

Study information

• Verified date: August 2006
• Source: Danish Headache Center
• Contact: Mohammad Sohail Asghar, MD
• Phone: +4543232161
• Email: asgsoh01[@]glostruphosp.kbhamt.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Glyceryl trinitrate, azetazolamide

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in BOLD response
Primary	Changes in a. cerebri media diameter
Primary	Changes in CBF
Secondary	headache score