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

Karolinska University Hospital

Status: Terminated

Conditions: Migraine

Treatments: Device: In-house prototype invented by Jan-Erik Juto

Study type: Interventional

Funder types: Other

Identifiers

NCT01488110

Migraine2011/1609-31/2

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Migraine medical device

Experimental group

Description:

Treatment with an active nasal probe

Treatment:

Device: In-house prototype invented by Jan-Erik Juto

Device: In-house prototype invented by Jan-Erik Juto

Inactive migraine medical device

Placebo Comparator group

Description:

Treatment with an inactive nasal probe.

Treatment:

Device: In-house prototype invented by Jan-Erik Juto

Device: In-house prototype invented by Jan-Erik Juto