Healthy Volunteers, Headache, Migraine, Hemodynamics, VIP, SPECT, Ultrasound
Conditions
Keywords
healthy volunteers, headache, migraine, hemodynamics, VIP, SPECT, ultrasound
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.
Interventions
DRUGVIP
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
\- healthy volunteers
Exclusion criteria
\- migraine cerebrovascular disorders pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Denmark
Outcome results
None listed