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:
Information provided by (Responsible Party):
Jan-Erik Juto, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01488110
First received: December 2, 2011
Last updated: June 17, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Karolinska University Hospital:

Primary Outcome Measures:
  • Change from baseline in pain intensity according to VAS-scales (0-10) [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    ECG will be obtained during treatment

  • Change from baseline in sympathetic nervous system activity [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: No ]
    Plethysmographic measurements will be obtained during treatment (finger clamp on finger).

  • Blood pressure [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from baseline in attack intensity based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline in attack duration based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline in medicine consumption based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 2, 2011
Last Updated: June 17, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014