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Cerebri Biofeedback Feasibility Trial (CER-MIG-1)

Primary Purpose

Episodic Migraine

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Biofeedback

About this trial

This is an interventional other trial for Episodic Migraine focused on measuring Biofeedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

St.Olavs Hospital HF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biofeedback Treatment Group

Arm Description

Medical device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Mean mHealth app usability questionnaire (MAUQ) score at treatment week 1 and 12

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

Modified System Usability Scale (SUS) questionnaire score at treatment weeks 1 and 12

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.

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

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

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.

Full Information

NCT ID

NCT05454319

First Posted

July 1, 2022

Last Updated

November 10, 2022

Sponsor

Nordic Brain Tech AS

Collaborators

St. Olavs Hospital, Norwegian University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT05454319

Brief Title

Cerebri Biofeedback Feasibility Trial

Acronym

CER-MIG-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

September 27, 2022 (Actual)

Study Completion Date

September 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nordic Brain Tech AS

Collaborators

St. Olavs Hospital, Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Episodic Migraine

Keywords

Biofeedback

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biofeedback Treatment Group

Arm Type

Experimental

Arm Description

Medical device

Intervention Type

Device

Intervention Name(s)

Biofeedback

Other Intervention Name(s)

CEREBRI

Intervention Description

Home-based biofeedback with medical device

Primary Outcome Measure Information:

Title

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

Description

Extraction of data from headache diary and completed biofeedback sessions

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

Mean mHealth app usability questionnaire (MAUQ) score at treatment week 1 and 12

Time Frame

3 months

Title

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

Description

Modified System Usability Scale (SUS) questionnaire score at treatment weeks 1 and 12

Time Frame

3 months

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

Descriptive assessment of users' experience of use of intervention, by semi-structured interviews to evaluate design and ease of use

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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%).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tore W Meisingset, MD, PhD

Organizational Affiliation

St. Olavs Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St.Olavs Hospital HF

City

Trondheim

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Cerebri Biofeedback Feasibility Trial

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