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

Norwegian University of Science and Technology

Status: Terminated

Conditions: Migraine Disorders

Treatments: Behavioral: Biofeedback training via app on smartphone; Behavioral: Sham-biofeedback training via app on smartphone

Study type: Interventional

Funder types: Other

Identifiers

NCT04106505

2018/35

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 2 patient groups

Biofeedback

Experimental group

Description:

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.

Treatment:

Behavioral: Biofeedback training via app on smartphone

Sham-biofeedback

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham-biofeedback training via app on smartphone