Chronic Migraines and Neurofdeeback Mindfulness

NCT06342219 | Not Yet Recruiting DMC

• 1 other identifier: 423629
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study.

Conditions

Chronic Migraine, Headache

Keywords

neurofeedback mindfulness; headache management self-efficacy; chronic migraines; dependence behaviours; migraine severity

Outcome Measures

Primary Outcomes (4)

• Migraine Disability

  measured by Migraine Disability Assessment Scale (MIDAS)

  8 weeks

• Migraine Severity

  measured by Headache Impact Test-short form (HIT-6)

  8 weeks

• Headache management self-efficacy

  measured by Headache Management Self-Efficacy Scale

  8 weeks

• Dependence on medicine

  measured by Severity of Dependence Scale (SDS)

  8 weeks

Secondary Outcomes (2)

• Anxiety

  8 weeks

• Depression

  8 weeks

Study Arms (3)

neurofeedback mindfulness

EXPERIMENTAL

This group is asked to do 10 min/day practice of neurofeedback mindfulness for 8 weeks. They should sit comfortably in a quiet area and do one of ten beginner self-guided mindfulness sessions on mind-body scanning techniques from within the MUSE app. Each session includes a brief explanation for 2-3 minutes before the practice. Once the participants start their practices, they receive sounds for their real-time brain activities: thunderstorm for an active state, ocean waves for a neutral state, and birds chirping for a relaxed state. For each five seconds of consistent relaxed state, the participants are reinforced with points.

Behavioral: Neurofeedback Mindfulness

Attention Task

ACTIVE COMPARATOR

The participants in the controlled intervention group are assigned to have an attention routine in a relaxed position. They are required to sit comfortably and relax in a quiet area to put on their MUSE headband, set it up, and use the same practices on MUSE app but they will mute all the neurofeedback sounds and instructions. Instead, on their smartphone the participants will check their emails, the news, or their preferred social media platform for 10 minutes. Once the session is over, the participants receive the graphical feedback of their brain activities. The feedback includes a timeline indicating their brain states (active, or relaxed) during the 10-minute session.

Behavioral: Attention Task

Waitlisted Group

NO INTERVENTION

The participants in this group are informed about being appointed in the waitlisted group and that we will only be collecting headache data from them for 8 weeks. They will complete the questionnaires for three rounds (i.e., Week 1, Week 4, and Week 8) and information about their headaches will be collected via the headache diaries. After 8 weeks, they will receive the MUSE device and will be offered a complementary session on how to use the device for their personal use. A debriefing form will be emailed to all the participants after completion of the study.

Interventions

Neurofeedback Mindfulness BEHAVIORAL

The participants will use a portable EEG headband (MUSE) which is a noninvasive tool for collecting EEG data. They will receive real-time EEG data given an audio feedback while doing their daily mindfulness practice.

neurofeedback mindfulness

Attention Task BEHAVIORAL

The participants in this arm will use the portable EEG while listening to an audiobook. They will receive a summary of their brain activities after task completion on each day.

Attention Task

Eligibility Criteria

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

You may qualify if:

• have a diagnosis of chronic migraine from a clinician or have met the criteria for a chronic migraine diagnosis based on ICHD-3
• reside in Saskatoon area
• have a smartphone and internet connection for accessing the MUSE app
• have no frequent background experience of meditation

You may not qualify if:

• Comorbidity of Raynaud's syndrome or diabetes
• Current use of a preventative migraine treatment over 6 months

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5A2, Canada

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Faly Golshan, PhD Candidate

CONTACT

3062702765; faly.golshan@usask.ca

Marla Mickleborough, PhD

CONTACT

marla.mick@usask.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Marla Mickleborough

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)