The purpose of this study is to investigate feasibility, usability, safety, efficacy, and tolerability of Cerebri biofeedback treatment for adults with episodic migraine. In the study, the app-based biofeedback treatment Cerebri for migraines in adults will be tested. By using biofeedback, bodily signals that are thought to be associated with migraines, are measured. During the treatment, one sensor is attached on the shoulder to measure activity in the shoulder and neck muscles and one sensor is attached to the index finger to measure temperature and heart rate variability. By getting on-screen feedback on the phone, the user can learn techniques to reduce muscle tension, and increase finger temperature and heart rate variability. Reduced muscle tension, as well as increase in finger temperature and heart rate variability is a sign of relaxation and a deactivation of the nervous system, which can lead to fewer and less serious migraine attacks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Home-based biofeedback with medical device
St.Olavs Hospital HF
Trondheim, Norway
Feasibility of intervention assessed by number of days with logged headache per 28-day period, number of biofeedback sessions per 28-day period, and mean session duration
Extraction of data from headache diary and completed biofeedback sessions
Time frame: 3 months
Usability of intervention assessed by mHealth app usability questionnaire (MAUQ)
Mean mHealth app usability questionnaire (MAUQ) score at treatment week 1 and 12
Time frame: 3 months
Usability of intervention assessed by modified System Usability Scale (SUS) questionnaire
Modified System Usability Scale (SUS) questionnaire score at treatment weeks 1 and 12
Time frame: 3 months
Initial estimates of efficacy and onset of efficacy assessed by number of migraine days
Change in the mean number of 28-day period migraine days from before treatment, to treatment weeks 1-4, weeks 5-8 and weeks 9-12.
Time frame: 3 months
Descriptive assessment of patients' belief about treatment efficacy assessed by Patient Global Impression of Change Scale (PGIC)
Change in self-reported treatment efficacy by the Patient Global Impression of Change Scale (PGIC) from before treatment to end-of-treatment
Time frame: 3 months
Change in subject-reported, headache-related disability assessed by Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)
Change in subject-reported, headache-related disability measured using the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1), from before treatment to end-of-treatment
Time frame: 3 months
Descriptive assessment of users' experience of use of intervention, by semi-structured interviews to evaluate design and ease of use
Semi-structured interviews to evaluate design and ease of use of intervention, at treatment week 6 and 12, in a subset of subjects.
Time frame: 3 months
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