Migraine
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks, and presence of a preventive effect post treatment.
Interventions
DEVICEInactive Migraine Medical Device
DEVICEMigraine Medical Device
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Female or male subjects, in otherwise good health, 20 to 55 years of age * Subjects who meet the ICHD-2 (2nd Edition of The International Headache Classification) criteria for migraine headache * Subjects with a minimum of 1 migraine attack per month * Attack duration of 4 to 72 hours * Normal attack intensity of at least 4 on a 0-10 VAS-scale
Exclusion criteria
* Completed heart surgery * Cardiovascular disease * Vascular damage on neck vessels * Disease other than migraine of the CSN * Severe disease of vital body organs * Severe psychiatric disorders * More than 6 migraine attacks per month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in pain intensity according to VAS-scales (0-10) | Estimated 30 minutes |
Countries
Sweden
Outcome results
None listed