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

Not Applicable

Terminated

• Conditions: Migraine
• Interventions: Device: In-house prototype invented by Jan-Erik Juto

• Registration Number: NCT01488110
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Study Start: 2012-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Migraine medical device	In-house prototype invented by Jan-Erik Juto	Treatment with an active nasal probe
Inactive migraine medical device	In-house prototype invented by Jan-Erik Juto	Treatment with an inactive nasal probe.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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

Trial Locations

Locations (1)

Karolinska University Hospital, Huddinge; 🇸🇪 Stockholm, Sweden