An interventional study of In-house prototype invented by Jan-Erik Juto and In-house prototype invented by Jan-Erik Juto in Migraine, sponsored by Karolinska University Hospital. Terminated at 1 site in Sweden. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-06-18.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with an active nasal probe
Device: In-house prototype invented by Jan-Erik Juto
Treatment with an inactive nasal probe.
Device: In-house prototype invented by Jan-Erik Juto
30 minutes treatment with an active nasal probe.
30 minutes treatment with an inactive nasal probe.
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.
Time frame: Estimation 40 minutes
RR (Heart rate)-interval
ECG will be obtained during treatment
Time frame: Estimation 40 minutes
Change from baseline in sympathetic nervous system activity
Plethysmographic measurements will be obtained during treatment (finger clamp on finger).
Time frame: Estimation 40 minutes
Blood pressure
Will be obtained prior to treatment initiation and post treatment
Time frame: Estimation 40 minutes
Change from baseline in attack frequency based on completed patient diaries
Time frame: 3 to 4 months
Change from baseline in attack intensity based on completed patient diaries
Time frame: 3 to 4 months
Change from baseline in attack duration based on completed patient diaries
Time frame: 3 to 4 months
Change from baseline in medicine consumption based on completed patient diaries
Time frame: 3 to 4 months
This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital