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

Not Applicable

Terminated

• Conditions: Migraine Disorders

• Registration Number: NCT04106505
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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.

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 Timeline

• Study Start: 2019-01-11
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Primary Completion: 2020-04-29
• Study Completion: 2020-04-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Headache frequency	Baseline and last 28 days of treatment	Mean change in headache frequency from baseline to end of treatment. Evaluated as number of headache days.

Secondary Outcome Measures

Name	Time	Method
Maximal pain intensity	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).
Responder rate	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
Abortive drug consumption	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.

Trial Locations

Locations (2)

Oslo Universitetssykehuse, Ullevål; 🇳🇴 Oslo, Norway

St. Olavs Hospital; 🇳🇴 Trondheim, Norway