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

NCT04106505 — Not applicable, Terminated, 23 participants, Norwegian University of Science and Technology

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Registry	NCT04106505
Status	Terminated - Recruitment terminated prematurely due to SARS-CoV-2 pandemic
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	23 (Actual)
Sponsor	Norwegian University of Science and Technology (Other); collaborators: Ullevaal University Hospital
Conditions	Migraine Disorders
Interventions	Biofeedback training via app on smartphone, Sham-biofeedback training via app on smartphone (Behavioral)
Dates	start 2019-01-11, primary completion 2020-04-29, completion 2020-04-29, first posted 2019-09-27, last updated 2020-07-08
Locations	2 sites in Norway

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Biofeedback	Experimental	Behavioral: 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 comparator	Behavioral: 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.

Biofeedback training via app on smartphone (Behavioral): Biofeedback training as described in biofeedback arm.
Sham-biofeedback training via app on smartphone (Behavioral): Sham-biofeedback training as described in sham-biofeedback arm.

+Outcome measures

Primary outcomes

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 outcomes

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
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).
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.

Other outcomes

Treatment adherence [During the two month treatment period]: Estimate of adherence by evaluating how many treatment sessions were completed during the treatment period.

+Eligibility

Sex: All, ages: 12 Years to 18 Years

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.

+Locations (2)

Facility	City	Country	Status
Oslo Universitetssykehuse, Ullevål	Oslo	Norway
St. Olavs Hospital	Trondheim	Norway

+Publications

Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. 2007 Mar;128(1-2):111-27. doi: 10.1016/j.pain.2006.09.007. Epub 2006 Nov 2. PMID 17084028
Palermo TM, Eccleston C, Lewandowski AS, de C Williams AC, Morley S. Randomized controlled trials of psychological therapies for management of chronic pain in children and adolescents: an updated meta-analytic review. Pain. 2010 Mar;148(3):387-397. doi: 10.1016/j.pain.2009.10.004. Epub 2009 Nov 11. PMID 19910118
Stubberud A, Varkey E, McCrory DC, Pedersen SA, Linde M. Biofeedback as Prophylaxis for Pediatric Migraine: A Meta-analysis. Pediatrics. 2016 Aug;138(2):e20160675. doi: 10.1542/peds.2016-0675. PMID 27462067

+Investigators

Øystein Risa, Study director, Norwegian University of Science and Technology