Experimental Headache Induced by Vasoactive Intestinal Polypeptide

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double

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.

Interventions

  • Drug: VIP

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • healthy volunteers Exclusion Criteria:
  • migraine cerebrovascular disorders pregnancy
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 60 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Danish Headache Center
    • Overall Official(s)
      • Jakob Møller Hansen, MD, Study Chair, Danish Headache Center

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