Experimental Headache Induced by Vasoactive Intestinal Polypeptide

Not Applicable

Completed

• Conditions: Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound

• Registration Number: NCT00255320
• Lead Sponsor: Danish Headache Center

Brief Summary

We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters.

Detailed Description

We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels. To test this hypothesis, we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters. In a double-blind, placebo-controlled, crossover design, the subjects were randomly allocated to receive 8 pmol/kg/min VIP or placebo (isotonic saline) over 25 min. Headache intensity, Mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion. Single photon emission computerized tomography (SPECT) was performed at T-0, T20 and T60.

Study Timeline

• Status Verified: 2003-12
• Study Start: 2003-12
• Study Completion: 2004-06
• Study First Submitted: 2005-11-16
• Study First Submitted QC: 2005-11-16
• Study First Posted: 2005-11-18
• Last Update Submitted: 2005-12-07
• Last Update Posted: 2005-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• healthy volunteers

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Exclusion Criteria

• migraine cerebrovascular disorders pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Headache intensity, Mean velocity of blood flow in the middle cerebral artery (VmeanMCA), superfical temporal artery diameter, PetCO2, adverse events and vital signs were recorded at T-10, T0 and then every 10 min until 120 min after start of infusion.

Secondary Outcome Measures

Name	Time	Method
All subjects were asked to complete a headache diary every hour until 10 h after the discharge. The diary included headache characteristics and accompanying symptoms according to the International Headache Society (IHS 2004)

Trial Locations

Locations (1)

Danish Headache Center , KAS Glostrup; 🇩🇰 Glostrup, Copenhagen, Denmark