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

Primary Purpose

Migraine

Status

Terminated

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

In-house prototype invented by Jan-Erik Juto

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Karolinska University Hospital, Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Migraine medical device

Inactive migraine medical device

Arm Description

Treatment with an active nasal probe

Treatment with an inactive nasal probe.

Outcomes

Primary Outcome Measures

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

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

ECG will be obtained during treatment

Change from baseline in sympathetic nervous system activity

Plethysmographic measurements will be obtained during treatment (finger clamp on finger).

Blood pressure

Will be obtained prior to treatment initiation and post treatment

Change from baseline in attack frequency based on completed patient diaries

Change from baseline in attack intensity based on completed patient diaries

Change from baseline in attack duration based on completed patient diaries

Change from baseline in medicine consumption based on completed patient diaries

Full Information

NCT ID

NCT01488110

First Posted

December 2, 2011

Last Updated

June 17, 2013

Sponsor

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01488110

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Terminated

Why Stopped

Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.

Study Start Date

January 2012 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 two months post treatment. Another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Migraine medical device

Arm Type

Experimental

Arm Description

Treatment with an active nasal probe

Arm Title

Inactive migraine medical device

Arm Type

Placebo Comparator

Arm Description

Treatment with an inactive nasal probe.

Intervention Type

Device

Intervention Name(s)

In-house prototype invented by Jan-Erik Juto

Intervention Description

30 minutes treatment with an active nasal probe.

Intervention Type

Device

Intervention Name(s)

In-house prototype invented by Jan-Erik Juto

Intervention Description

30 minutes treatment with an inactive nasal probe.

Primary Outcome Measure Information:

Title

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

Description

Documentation of pain intensity prior to treatment initiation (baseline value), every 5 minutes during treatment and post treatment.

Time Frame

Estimation 40 minutes

Secondary Outcome Measure Information:

Title

RR (Heart rate)-interval

Description

ECG will be obtained during treatment

Time Frame

Estimation 40 minutes

Title

Change from baseline in sympathetic nervous system activity

Description

Plethysmographic measurements will be obtained during treatment (finger clamp on finger).

Time Frame

Estimation 40 minutes

Title

Blood pressure

Description

Will be obtained prior to treatment initiation and post treatment

Time Frame

Estimation 40 minutes

Title

Change from baseline in attack frequency based on completed patient diaries

Time Frame

3 to 4 months

Title

Change from baseline in attack intensity based on completed patient diaries

Time Frame

3 to 4 months

Title

Change from baseline in attack duration based on completed patient diaries

Time Frame

3 to 4 months

Title

Change from baseline in medicine consumption based on completed patient diaries

Time Frame

3 to 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juto

Organizational Affiliation

Karolinska University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska University Hospital, Huddinge

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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