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Effect of GTN and Diamox Measured by BOLD-Response.

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ClinicalTrials.gov Identifier: NCT00363792
Recruitment Status : Unknown
Verified August 2006 by Danish Headache Center.
Recruitment status was:  Recruiting
First Posted : August 15, 2006
Last Update Posted : August 15, 2006
Sponsor:
Information provided by:
Danish Headache Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Glyceryl trinitrate, azetazolamide Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
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 Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Changes in BOLD response
  2. Changes in a. cerebri media diameter
  3. Changes in CBF

Secondary Outcome Measures :
  1. headache score

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363792


Contacts
Contact: Mohammad Sohail Asghar, MD +4543232161 asgsoh01@glostruphosp.kbhamt.dk

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2770
Contact: Mohammad Sohail Asghar, MD    +4543232161    asgsoh01@glostruphosp.kbhamt.dk   
Principal Investigator: Mohammad Sohail Asghar, MD         
Sponsors and Collaborators
Danish Headache Center
Investigators
Study Chair: Messoud Ashina, MD, Phd, Danish Headache Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00363792     History of Changes
Other Study ID Numbers: KA-20060085
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: August 2006

Keywords provided by Danish Headache Center:
Healthy subjects

Additional relevant MeSH terms:
Nitroglycerin
Vasodilator Agents