Cerebri Biofeedback Feasibility Trial

NCT05454319 | Completed

• 1 other identifier: 457654
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Episodic Migraine

Keywords

Biofeedback

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Usability of intervention assessed by mHealth app usability questionnaire (MAUQ)

  3 months

• Usability of intervention assessed by modified System Usability Scale (SUS) questionnaire

  3 months

• Initial estimates of efficacy and onset of efficacy assessed by number of migraine days

  3 months

• Descriptive assessment of patients' belief about treatment efficacy assessed by Patient Global Impression of Change Scale (PGIC)

  3 months

• Change in subject-reported, headache-related disability assessed by Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)

  3 months

Study Arms (1)

Biofeedback Treatment Group

EXPERIMENTAL

Medical device

Device: Biofeedback

Interventions

Biofeedback DEVICE

Home-based biofeedback with medical device

Also known as: CEREBRI

Biofeedback Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Nordic Brain Tech AS: lead
• St. Olavs Hospital: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St.Olavs Hospital HF

Trondheim, Norway

Location

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Tore W Meisingset, MD, PhD

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 12, 2022
• Study Start: June 1, 2022
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

NO (1)