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Behavioral Intervention

neurofeedback mindfulness for Migraine

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dependence on medicine
Headache management self-efficacy
Migraine Disability
+1 more
Secondary outcome measures
Anxiety
Depression

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: 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.
Group III: 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.

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Who is running the clinical trial?

University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,275 Total Patients Enrolled
1 Trials studying Migraine
101 Patients Enrolled for Migraine
Saskatchewan Health Research FoundationOTHER
32 Previous Clinical Trials
4,854 Total Patients Enrolled
1 Trials studying Migraine
101 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current clinical trial open for enrollment?

"The information available on clinicaltrials.gov shows that patient recruitment for this particular trial has concluded. Despite being first posted on 12/1/2024 and most recently revised on 3/26/2024, the study is not actively enrolling participants. However, there are currently 247 other ongoing trials seeking eligible individuals to participate in various research studies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Chronic Migraines and Neurofdeeback Mindfulness
Marla Mickleborough 2024. "Chronic Migraines and Neurofdeeback Mindfulness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06342219.
All > Migraine Headaches
~90 spots leftby Dec 2025
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