Clinical trial NCT04106505: Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study
Official title: Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine Disorders
Keywords: Biofeedback
smartphone app
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Ullevaal University Hospital
First posted: 2019-09-27
Enrollment: 23
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will begin with a one-month baseline period, followed by a two-month treatment period. Participants will randomly be assigned to one of two groups by a computer-generated block-randomization list. In each block of four, participants will have a 75% chance of being allocated to the biofeedback group and 25% chance of being allocated to the sham group, to ensure 30 participants in the biofeedback group and 10 in the sham group. The randomization list will remain inaccessible to the investigators until end of follow-up of the last participant. Both participants and personnel will be blinded to the intervention given. It should be noted that this study is intended as a pilot study, and not a randomized controlled trial. Still, we wish to use randomization and blinding to ensure that the group receiving sham treatment is a random subset of the study population.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache frequency
timeFrame: Baseline and last 28 days of treatment
Secondary outcomes:
measure: Responder rate
timeFrame: Baseline and last 28 days of treatment
measure: Maximal pain intensity
timeFrame: Baseline and last 28 days of treatment
measure: Abortive drug consumption
timeFrame: Baseline and last 28 days of treatment
Other outcomes:
measure: Treatment adherence
timeFrame: During the two month treatment period
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehuse, Ullevål
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øystein Risa
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.