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

June 17, 2013 updated by: Jan-Erik Juto, Karolinska University Hospital

Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital, Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: In-house prototype invented by Jan-Erik Juto
30 minutes treatment with an inactive 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 active nasal probe.
Device: In-house prototype invented by Jan-Erik Juto
30 minutes treatment with an inactive nasal probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Estimation 40 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RR (Heart rate)-interval
Time Frame: Estimation 40 minutes
ECG will be obtained during treatment
Estimation 40 minutes
Change from baseline in sympathetic nervous system activity
Time Frame: Estimation 40 minutes
Plethysmographic measurements will be obtained during treatment (finger clamp on finger).
Estimation 40 minutes
Blood pressure
Time Frame: Estimation 40 minutes
Will be obtained prior to treatment initiation and post treatment
Estimation 40 minutes
Change from baseline in attack frequency based on completed patient diaries
Time Frame: 3 to 4 months
3 to 4 months
Change from baseline in attack intensity based on completed patient diaries
Time Frame: 3 to 4 months
3 to 4 months
Change from baseline in attack duration based on completed patient diaries
Time Frame: 3 to 4 months
3 to 4 months
Change from baseline in medicine consumption based on completed patient diaries
Time Frame: 3 to 4 months
3 to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Juto, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Migraine2011/1609-31/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe