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

NCT04106505 | Terminated

• 1 other identifier: 2018/35
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Migraine Disorders

Keywords

Biofeedback; smartphone app

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Responder rate

  Baseline and last 28 days of treatment

• Maximal pain intensity

  Baseline and last 28 days of treatment

• Abortive drug consumption

  Baseline and last 28 days of treatment

Other Outcomes (1)

• Treatment adherence

  During the two month treatment period

Study Arms (2)

Biofeedback

EXPERIMENTAL

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.

Behavioral: Biofeedback training via app on smartphone

Sham-biofeedback

SHAM COMPARATOR

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.

Behavioral: Sham-biofeedback training via app on smartphone

Interventions

Biofeedback training via app on smartphone BEHAVIORAL

Biofeedback training as described in biofeedback arm.

Biofeedback

Sham-biofeedback training via app on smartphone BEHAVIORAL

Sham-biofeedback training as described in sham-biofeedback arm.

Sham-biofeedback

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Ullevaal University Hospital: collaborator

Study Sites (2)

Oslo Universitetssykehuse, Ullevål

Oslo, 0450, Norway

Location

St. Olavs Hospital

Trondheim, 7030, Norway

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Øystein Risa

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The randomization number will be drawn sequentially from a list of 40 numbers where one random in every four numbers results in downloading a sham-version of the app. Both versions of the app look alike and no pattern in the 5-digit number or the randomization list can reveal which version of the app is given. This will ensure blinding of both participants and study personnel. Breaking of the randomization will be made after follow-up of the last participant. The software developers will at this point reveal what 5-digit numbers corresponded to the biofeedback or sham version of the app.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: January 11, 2019
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)