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

This study has been terminated.
(Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488110
First Posted: December 8, 2011
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan-Erik Juto, Karolinska University Hospital
  Purpose
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.

Condition Intervention
Migraine Device: In-house prototype invented by Jan-Erik Juto

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)

Resource links provided by NLM:


Further study details as provided by Jan-Erik Juto, Karolinska University Hospital:

Primary Outcome Measures:
  • Change from baseline in pain intensity according to VAS-scales (0-10) [ Time Frame: Estimation 40 minutes ]
    Documentation of pain intensity prior to treatment initiation (baseline value), every 5 minutes during treatment and post treatment.


Secondary Outcome Measures:
  • RR (Heart rate)-interval [ Time Frame: Estimation 40 minutes ]
    ECG will be obtained during treatment

  • Change from baseline in sympathetic nervous system activity [ Time Frame: Estimation 40 minutes ]
    Plethysmographic measurements will be obtained during treatment (finger clamp on finger).

  • Blood pressure [ Time Frame: Estimation 40 minutes ]
    Will be obtained prior to treatment initiation and post treatment

  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2012
Arms Assigned Interventions
Experimental: Migraine medical device
Treatment with an active nasal probe
Device: In-house prototype invented by Jan-Erik Juto
30 minutes treatment with an active nasal probe.
Placebo Comparator: Inactive migraine medical device
Treatment with an inactive nasal probe.
Device: In-house prototype invented by Jan-Erik Juto
30 minutes treatment with an inactive nasal probe.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488110


Locations
Sweden
Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Juto Karolinska University Hospital
  More Information

Responsible Party: Jan-Erik Juto, Adjunct professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01488110     History of Changes
Other Study ID Numbers: Migraine2011/1609-31/2
First Submitted: December 2, 2011
First Posted: December 8, 2011
Last Update Posted: June 18, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases