Study Protocol for a Randomized Controlled Trial of Neurofeedback Mindfulness in Chronic Migraines
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Saskatchewan
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Migraine Disability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Comorbidity of Raynaud's syndrome or diabetes
- •Current use of a preventative migraine treatment over 6 months
Arms & Interventions
neurofeedback mindfulness
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.
Intervention: Neurofeedback Mindfulness (Behavioral)
Attention Task
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.
Intervention: Attention Task (Behavioral)
Waitlisted Group
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.
Outcomes
Primary Outcomes
Migraine Disability
Time Frame: 8 weeks
measured by Migraine Disability Assessment Scale (MIDAS)
Migraine Severity
Time Frame: 8 weeks
measured by Headache Impact Test-short form (HIT-6)
Dependence on medicine
Time Frame: 8 weeks
measured by Severity of Dependence Scale (SDS)
Headache management self-efficacy
Time Frame: 8 weeks
measured by Headache Management Self-Efficacy Scale
Secondary Outcomes
- Anxiety(8 weeks)
- Depression(8 weeks)
Investigators
Marla Mickleborough
Dr. Marla Mickleborough
University of Saskatchewan