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
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 April 17, 2014