Cerebri Biofeedback Feasibility Trial (CER-MIG-1)

A Prospective Feasibility Study of Daily, Home-based Biofeedback Therapy Using Cerebri for Migraine Treatment.

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 Overview

• Status: Completed
• Conditions: Episodic Migraine
• Intervention / Treatment: Device: Biofeedback

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St.Olavs Hospital HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Biofeedback Treatment Group; Medical device	Device: Biofeedback; Home-based biofeedback with medical device; Other Names: CEREBRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of intervention assessed by mHealth app usability questionnaire (MAUQ)	Mean mHealth app usability questionnaire (MAUQ) score at treatment week 1 and 12	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	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.	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	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	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.	3 months

Collaborators and Investigators

• Sponsor: Nordic Brain Tech AS
• Collaborators: Norwegian University of Science and Technology; St. Olavs Hospital
• Investigators: Principal Investigator: Tore W Meisingset, MD, PhD, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2022
• Primary Completion (ACTUAL): September 27, 2022
• Study Completion (ACTUAL): September 27, 2022

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (ACTUAL): July 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Biofeedback
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 457654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No