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

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04106505
• Other study ID #: 2018/35
• Status: Terminated
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: April 29, 2020

Study information

• Verified date: July 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: April 29, 2020
• Est. primary completion date: April 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehuse, Ullevål	Oslo
Norway	St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. 2007 Mar;128(1-2):111-27. Epub 2006 Nov 2. Review. — View Citation

Palermo TM, Eccleston C, Lewandowski AS, 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):387-97. doi: 10.1016/j.pain.2009.10.004. Epub 2009 Nov 11. Review. — View 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). pii: e20160675. doi: 10.1542/peds.2016-0675. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment adherence	Estimate of adherence by evaluating how many treatment sessions were completed during the treatment period.	During the two month treatment period
Primary	Headache frequency	Mean change in headache frequency from baseline to end of treatment. Evaluated as number of headache days.	Baseline and last 28 days of treatment
Secondary	Responder rate	Defined as positive if there has been more than 50% decrease in headache frequency from baseline to end of treatment	Baseline and last 28 days of treatment
Secondary	Maximal pain intensity	Mean change in maximal pain intensity from baseline to end of treatment. Rated on a 4 point scale (0=no headache; 3=severe headache).	Baseline and last 28 days of treatment
Secondary	Abortive drug consumption	Mean change in abortive drug consumption form baseline to end of treatment. Defined as days with use of abortive drugs.	Baseline and last 28 days of treatment