Clinical trial NCT05454319: Cerebri Biofeedback Feasibility Trial
Official title: A Prospective Feasibility Study of Daily, Home-based Biofeedback Therapy Using Cerebri for Migraine Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episodic Migraine
Keywords: Biofeedback
Lead sponsor: Nordic Brain Tech AS
Sponsor class: OTHER_GOV
Collaborators: name: St. Olavs Hospital
name: Norwegian University of Science and Technology
First posted: 2022-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older, at the time of signing the informed consent
* Episodic migraines with or without aura diagnosed by a neurologist/physician per International Classification of Headache Disorders 3rd edition (ICHD-3).
* Having kept a headache diary with at least 80% adherence as part of routine clinical care in the last 28-days prior to inclusion.
* History of at least 4 and up to 14 days of migraines per 28-day period in the 3 months prior to screening, as recalled by the subject and confirmed in the clinical diary.
* At least three months of experience with smartphone and access to an iOS or Android phone at home.
* Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Onset of migraine before age 50 years.

Exclusion Criteria:

* Having a continuous background headache that never disappears completely.
* More than 14 days of headache (all types) per 28-day period.
* Subjects diagnosed with trigeminal autonomic cephalalgias and neuralgias.
* Subjects with secondary headache conditions.
* Subjects with headaches attributed by the treating neurologist/physician as being medication overuse headache according to the ICHD-3.
* Subject with pathologies that inhibit use of the device according to the instructions for use (e.g., blindness, deafness).
* Use of any concurrent preventive treatment (medications, meditation, physical therapy and psychotherapy as a headache treatment, acupuncture, etc.).
* Subjects who have previously failed three prophylactic pharmacological treatments.
* Subjects taking opioids (\>3 days per month) or barbiturates at the time of screening.
* Subject participates in another clinical investigation.
* Alcohol overuse according to ICD-10-CM Code F10.1 or illicit drug use.
* Subject who is unlikely to follow Clinical Investigation Plan or where treatment seems futile in the opinion of the Investigator or have demonstrated an inability to sufficiently adhere to headache diary entries (\<80%).

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Usability of intervention assessed by mHealth app usability questionnaire (MAUQ)
timeFrame: 3 months
measure: Usability of intervention assessed by modified System Usability Scale (SUS) questionnaire
timeFrame: 3 months
measure: Initial estimates of efficacy and onset of efficacy assessed by number of migraine days
timeFrame: 3 months
measure: Descriptive assessment of patients' belief about treatment efficacy assessed by Patient Global Impression of Change Scale (PGIC)
timeFrame: 3 months
measure: Change in subject-reported, headache-related disability assessed by Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)
timeFrame: 3 months
measure: Descriptive assessment of users' experience of use of intervention, by semi-structured interviews to evaluate design and ease of use
timeFrame: 3 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital HF
Study officials:
affiliation: St. Olavs Hospital
name: Tore W Meisingset, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: