Investigation of Efficacy and Outcome of a New Medical Device for Treatment of Migraine

Study Overview
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Brief Summary
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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.

Official Title
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Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)

Conditions
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Migraine

Intervention / Treatment
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* Device: In-house prototype invented by Jan-Erik Juto
* Device: In-house prototype invented by Jan-Erik Juto


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Migraine medical device<br>Treatment with an active nasal probe | Device: In-house prototype invented by Jan-Erik Juto<br>* 30 minutes treatment with an active nasal probe.<br>|
| Placebo Comparator: Inactive migraine medical device<br>Treatment with an inactive nasal probe. | Device: In-house prototype invented by Jan-Erik Juto<br>* 30 minutes treatment with an inactive nasal probe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain intensity according to VAS-scales (0-10) | Documentation of pain intensity prior to treatment initiation (baseline value), every 5 minutes during treatment and post treatment. | Estimation 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RR (Heart rate)-interval | ECG will be obtained during treatment | Estimation 40 minutes | 
| Change from baseline in sympathetic nervous system activity | Plethysmographic measurements will be obtained during treatment (finger clamp on finger). | Estimation 40 minutes | 
| Blood pressure | Will be obtained prior to treatment initiation and post treatment | Estimation 40 minutes | 
| Change from baseline in attack frequency based on completed patient diaries |  | 3 to 4 months | 
| Change from baseline in attack intensity based on completed patient diaries |  | 3 to 4 months | 
| 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 |