Migraine DisordersNCT04106505
Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study
A study testing Biofeedback training via app on smartphone in people with Migraine Disorders, run by Norwegian University of Science and Technology at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Biofeedback training via app on smartphone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesNorway
- Study dates
- 11 Jan 2019to 29 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo Universitetssykehuse, Ullevål
Oslo, 0450
St. Olavs Hospital
Trondheim, 7030
About this study
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.
Read the 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.
- Conditions
- Migraine Disorders
- Being tested
- Biofeedback training via app on smartphone, Sham-biofeedback training via app on smartphone
- Keywords
- Biofeedback, smartphone app
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback training via app on smartphoneBehavioural
Biofeedback training as described in biofeedback arm.
Sham-biofeedback training via app on smartphoneBehavioural
Sham-biofeedback training as described in sham-biofeedback arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham-biofeedback training via app on smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency
Mean change in headache frequency from baseline to end of treatment. Evaluated as number of headache days.
Measured: Baseline and last 28 days of treatment
Secondary outcomes (3)
Responder rate
Defined as positive if there has been more than 50% decrease in headache frequency from baseline to end of treatment
Measured: Baseline and last 28 days of treatment
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).
Measured: Baseline and last 28 days of treatment
Abortive drug consumption
Mean change in abortive drug consumption form baseline to end of treatment. Defined as days with use of abortive drugs.
Measured: Baseline and last 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start11 Jan 2019
- Primary completion29 Apr 2020
- Study completion29 Apr 2020
Why it stopped: Recruitment terminated prematurely due to SARS-CoV-2 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Ullevaal University Hospital
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106505
- Sponsor's protocol ID
- 2018/35
- Status last verified
- Jul 2020
- First submitted
- 25 Sep 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17084028Palermo 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.
PubMed 19910118Stubberud 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.
PubMed 27462067
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study
- ClinicalTrials.gov ID
- NCT04106505
- Acronym / sponsor ID
- 2018/35
- Conditions
- Migraine Disorders
- Keywords
- Biofeedback, smartphone app
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment terminated prematurely due to SARS-CoV-2 pandemic
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Ullevaal University Hospital
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: Biofeedback training via app on smartphoneThe 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 smartphoneSham-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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback training via app on smartphoneBiofeedback training as described in biofeedback arm. | Behavioural | Biofeedback |
| Sham-biofeedback training via app on smartphoneSham-biofeedback training as described in sham-biofeedback arm. | Behavioural | Sham-biofeedback |
Primary outcome
Headache frequency
Time frame: Baseline and last 28 days of treatment
Mean change in headache frequency from baseline to end of treatment. Evaluated as number of headache days.
3 secondary outcomes
Responder rate
Time frame: Baseline and last 28 days of treatment
Maximal pain intensity
Time frame: Baseline and last 28 days of treatment
Abortive drug consumption
Time frame: Baseline and last 28 days of treatment
Results and safety
The study was stopped early (reason given: Recruitment terminated prematurely due to SARS-CoV-2 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 17084028Nestoriuc 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.
- Background: PubMed 19910118Palermo 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.
- Background: PubMed 27462067Stubberud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa study director
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback training via app on smartphone in people with Migraine Disorders, run by Norwegian University of Science and Technology at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment terminated prematurely due to SARS-CoV-2 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (time frame: Baseline and last 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106505, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.