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

Not Applicable

Terminated

• Conditions: Migraine Disorders
• Interventions: Behavioral: Biofeedback training via app on smartphone; Behavioral: Sham-biofeedback training via app on smartphone

• 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

Arm && Interventions

Group	Intervention	Description
Biofeedback	Biofeedback training via app on smartphone	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.
Sham-biofeedback	Sham-biofeedback training via app on smartphone	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.

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