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Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Migraine medical device | Experimental | Treatment with an active nasal probe |
|
| Inactive migraine medical device | Placebo Comparator | Treatment with an inactive nasal probe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-house prototype invented by Jan-Erik Juto | Device | 30 minutes treatment with an active nasal probe. |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juto | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital, Huddinge | Stockholm | 14186 | Sweden |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| In-house prototype invented by Jan-Erik Juto | Device | 30 minutes treatment with an inactive nasal probe. |
|
| 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 |
| D009422 | Nervous System Diseases |