Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study

July 6, 2020 updated by: Norwegian University of Science and Technology
This study evaluates biofeedback delivered through a smartphone as a treatment for migraine in adolescents. Three out of four participants will receive treatment as smartphone delivered biofeedback training, and one out of four participants will receive treatment as a sham-biofeedback app.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Biofeedback is a behavioral treatment without known side effects. In biofeedback patients learn control over bodily reactions through feedback visualised on a screen. Typical bodily reactions that are displayed is heart rate and muscle tension. Biofeedback has for decades been considered as effective preventive treatment of migraine among children and adolescents. In spite of that, it is not available to most patients in need. This is most likely because it requires specialised stationary equipment and a trained therapist.

In this project, the researchers have developed a new smartphone biofeedback app connected to wearable, wireless sensors measuring muscle tension, finger temperature and heart rate. The app and sensors will be used to deliver biofeedback treatment to adolescents suffering for migraine. The goal of the study is to investigate the effect of the biofeedback treatment and the sham-biofeedback treatment on migraine headaches.

Study Type

Interventional

Enrollment (Actual)

23

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

  • Norway
      • Oslo, Norway, 0450
        • Oslo Universitetssykehuse, Ullevål
      • Trondheim, Norway, 7030
        • St. Olavs hospital

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of migraine with or without aura according to ICHD-3
  • two to eight migraine attacks per month
  • written informed consent signed by guardians, or by adolescent if age between 16-18 years.

Exclusion Criteria:

  • participant not speaking Norwegian
  • reduced sensibility, hearing or vision to a degree that impairs proper use of the app
  • serious psychiatric or neurologic disease and
  • currently using migraine prophylaxis.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback
The treatment comprises an app containing biofeedback training, instructions for self-delivery and a headache diary. The treatment utilizes these functionalities by a push-reminder in the app to complete a daily headache diary entry and a biofeedback session of 10 minutes duration daily. Prior to commencing treatment participants will be given basic information on the rationale behind biofeedback treatment, given instructions on how to use the equipment and software and instructions on how to complete a biofeedback session. The biofeedback is based on wireless sensors measuring muscle tension, finger temperature and heart rate.
Behavioral: Biofeedback training via app on smartphone
Biofeedback training as described in biofeedback arm.
Sham Comparator: Sham-biofeedback
Sham-biofeedback will be made by disrupting the connection between input of physiological parameters and the feedback. Thus, the feedback will simply be displayed as positive feedback occurring at random intervals throughout the sessions. The looks and contents of the normal app and the sham-app will be completely similar. The participants being allocated to the sham-goup will also use exactly the same sensor setup as the biofeedback group. The only difference between the two arms/interventions is the internal software algorithm, which will be inaccessible to the user. All participants in both groups will be given the same information and instructions.
Behavioral: Sham-biofeedback training via app on smartphone
Sham-biofeedback training as described in sham-biofeedback arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache frequency
Time Frame: Baseline and last 28 days of treatment
Mean change in headache frequency from baseline to end of treatment. Evaluated as number of headache days.
Baseline and last 28 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder rate
Time Frame: Baseline and last 28 days of treatment
Defined as positive if there has been more than 50% decrease in headache frequency from baseline to end of treatment
Baseline and last 28 days of treatment
Maximal pain intensity
Time Frame: Baseline and last 28 days of treatment
Mean change in maximal pain intensity from baseline to end of treatment. Rated on a 4 point scale (0=no headache; 3=severe headache).
Baseline and last 28 days of treatment
Abortive drug consumption
Time Frame: Baseline and last 28 days of treatment
Mean change in abortive drug consumption form baseline to end of treatment. Defined as days with use of abortive drugs.
Baseline and last 28 days of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: During the two month treatment period
Estimate of adherence by evaluating how many treatment sessions were completed during the treatment period.
During the two month treatment period

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Collaborators

Ullevaal University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 11, 2019

Primary Completion (Actual)

April 29, 2020

Study Completion (Actual)

April 29, 2020

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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