Trials / Terminated
TerminatedNCT04106505
Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Norwegian University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Biofeedback training via app on smartphone | Biofeedback training as described in biofeedback arm. |
| BEHAVIORAL | Sham-biofeedback training via app on smartphone | Sham-biofeedback training as described in sham-biofeedback arm. |
Timeline
- Start date
- 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 across 1 country: Norway
Source: ClinicalTrials.gov record NCT04106505. Inclusion in this directory is not an endorsement.