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 two months post treatment. Another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.
Interventions
DEVICEIn-house prototype invented by Jan-Erik Juto
30 minutes treatment with an active nasal probe.
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 diseases * Vascular damages on neck vessels * Diseases other than migraine of the CNS * Severe disease of vital body organs * Severe psychiatric disorders * More than 6 migraine attacks per month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain intensity according to VAS-scales (0-10) | Estimation 40 minutes | Documentation of pain intensity prior to treatment initiation (baseline value), every 5 minutes during treatment and post treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in sympathetic nervous system activity | Estimation 40 minutes | Plethysmographic measurements will be obtained during treatment (finger clamp on finger). |
| Blood pressure | Estimation 40 minutes | Will be obtained prior to treatment initiation and post treatment |
| Change from baseline in attack frequency based on completed patient diaries | 3 to 4 months | — |
| RR (Heart rate)-interval | Estimation 40 minutes | ECG will be obtained during treatment |
| Change from baseline in attack duration based on completed patient diaries | 3 to 4 months | — |
| Change from baseline in medicine consumption based on completed patient diaries | 3 to 4 months | — |
| Change from baseline in attack intensity based on completed patient diaries | 3 to 4 months | — |
Countries
Sweden
Outcome results
None listed