Neurofeedback Mindfulness for Migraines

N/A

Waitlist Available

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate how chronic migraine sufferers benefit from an 8-week practice of neurofeedback mindfulness compared to other groups. The study will also look at whether participants can reduce their reliance on medications after completing

Who is the study for?

This trial is for individuals in the Saskatoon area who have been diagnosed with chronic migraines and haven't practiced meditation frequently. They must own a smartphone, have internet access to use the MUSE app, and not be on any preventative migraine treatment for over 6 months or have Raynaud's syndrome or diabetes.

What is being tested?

The study tests if neurofeedback mindfulness over an 8-week period can help chronic migraine sufferers compared to those doing attention tasks or on a waitlist. It also examines if this practice reduces reliance on medication after the study.

What are the potential side effects?

Since this trial involves non-invasive practices like mindfulness and attention tasks, side effects are minimal but may include discomfort due to unfamiliarity with the techniques or frustration from potential lack of immediate results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dependence on medicine

Headache management self-efficacy

Migraine Disability

+1 more

Secondary study objectives

Anxiety

Depression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: neurofeedback mindfulnessExperimental Treatment1 Intervention

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.

Group II: Attention TaskActive Control1 Intervention

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.

Group III: Waitlisted GroupActive Control1 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.

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