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CompletedNCT01880671Updated Apr 1, 2014

Evaluation of a New Treatment for Migraine Attacks

An interventional study of Inactive Migraine Medical Device and Migraine Medical Device in Migraine, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2014-04-01.

Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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 post treatment.

02

Conditions studied

  • Migraine

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03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 36 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Completed heart surgery
  • Cardiovascular disease
  • Vascular damage on neck vessels
  • Disease other than migraine of the CSN
  • Severe disease of vital body organs
  • Severe psychiatric disorders
  • More than 6 migraine attacks per month
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Migraine Medical Device

    Device: Migraine Medical Device

  • Placebo comparator
    Inactive Migraine Medical Device

    Device: Inactive Migraine Medical Device

Interventions

  • DeviceInactive Migraine Medical Device
  • DeviceMigraine Medical Device
06

What researchers measure

Primary outcomes

  1. Change from baseline in pain intensity according to VAS-scales (0-10)

    Time frame: Estimated 30 minutes

07

Study locations

1 site
  • Karolinska University Hospital, Huddinge
    Stockholm, 14186, Sweden
08

References and documents

Publications

  • Juto JE, Hallin RG. Kinetic oscillation stimulation as treatment of acute migraine: a randomized, controlled pilot study. Headache. 2015 Jan;55(1):117-27. doi: 10.1111/head.12485. Epub 2014 Dec 29. PubMed 25546476 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01880671
Lead sponsor
Karolinska University Hospital
Responsible party
Jan-Erik Juto (Affiliated professor, Karolinska University Hospital) — Principal investigator
First posted
Jun 19, 2013
Start date
May 2013
Primary completion
Mar 2014
Last update
Apr 1, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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