Neurofeedback Mindfulness for Migraines

Overseen By Marla Mickleborough, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Saskatchewan

Must not be taking: Preventative migraine treatments

Disqualifiers: Raynaud's syndrome, diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

135 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not be using a preventative migraine treatment for over 6 months. It might be best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Attention Task, Neurofeedback Mindfulness for migraines?

Research suggests that mindfulness-based interventions can help improve headache-related disability and psychological well-being in migraine sufferers. Initial findings also indicate that mindfulness alone may have effects comparable to medication for chronic migraine with medication overuse. ^{1 2 3 4 5}

Is Neurofeedback Mindfulness safe for humans?

Mindfulness-based stress reduction (MBSR), a type of mindfulness intervention, is considered safe and has no known side effects. It has been used effectively for various chronic pain conditions, including migraines. ^{1 4 6 7 8}

How does Neurofeedback Mindfulness treatment for migraines differ from other treatments?

Neurofeedback Mindfulness is unique because it combines mindfulness techniques, which help patients focus their attention and manage stress, with biofeedback, which teaches them to control physiological functions like blood flow. This non-drug approach can reduce migraine pain and medication use, offering an alternative for those who cannot tolerate or afford traditional medications. ^{1 3 4 9 10}

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with chronic migraines by a doctor.

Having a smartphone and internet connection for accessing the MUSE app

Having no frequent background experience of meditation

Exclusion Criteria

I have been using a migraine prevention treatment for over 6 months.

I have Raynaud's syndrome or diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in neurofeedback mindfulness or attention tasks for 8 weeks

8 weeks

3 visits (in-person) for questionnaires and data collection

Follow-up

Participants are monitored for changes in migraine severity, medicine dependence, and other outcomes

4 weeks

Treatment Details

Interventions

• Attention Task
• Neurofeedback Mindfulness

Trial Overview 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.

Participant Groups

Group I: neurofeedback mindfulness Experimental Treatment 1 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 Task Active Control 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Saskatchewan Health Research Foundation

Collaborator

Trials

33

Recruited

5,100+

Findings from Research

Mindfulness-Based Cognitive Therapy for Migraine (MBCT-M) significantly reduces headache-related disability, particularly in individuals with episodic migraine, as shown in a study of 60 participants.

The therapy was more effective for episodic migraine sufferers, reducing severe disability by 40%, compared to only a 16.4% reduction in those with chronic migraine, indicating that the benefits of MBCT-M vary based on the type of migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. Seng, EK., Conway, AB., Grinberg, AS., et al.[2022]

Participants in mindfulness-based stress reduction (MBSR) reported significant changes in their pain perception and response to migraine attacks, leading to improved overall well-being and earlier recognition of migraine symptoms for better management.

Mindfulness practices helped reduce negative feelings associated with migraines, such as fear and anxiety, while increasing positive factors like self-acceptance and self-compassion, suggesting that mindfulness can effectively address both the psychological and physical aspects of migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of mindfulness in patients with migraine: Results of a qualitative study. Estave, PM., Margol, C., Beeghly, S., et al.[2023]

Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT), show promise as non-pharmacological treatments for migraine, potentially improving headache-related disability and psychological well-being.

While current research is mostly based on small pilot trials, further studies are needed to determine the most effective ways to implement MBIs, including optimal dosage and delivery methods, as they may serve as valuable tools in a comprehensive migraine management plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in migraine: A narrative review. Wells, RE., Seng, EK., Edwards, RR., et al.[2021]

In a study with 24 migraine sufferers, those who practiced a combination of temporal cooling, frontalis relaxation, and progressive muscular relaxation experienced the most significant relief from headaches.

Control subjects who did not engage in these techniques reported no headache relief, highlighting the effectiveness of the behavioral strategies over relaxation exercises alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal biofeedback in the treatment of migraine. Gamble, EH., Elder, ST.[2019]

This study is a pilot trial investigating the effectiveness of mindfulness-based stress reduction (MBSR) for treating moderate-to-severe episodic migraines, involving approximately 60 participants and lasting 8 weeks.

MBSR is a low-cost intervention with no known side effects, and if successful, it could lead to a larger clinical trial aimed at confirming its effectiveness in reducing headache days for migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M). Pressman, A., Law, H., Stahl, R., et al.[2020]

The 8-week mindfulness-based stress reduction (MBSR) course was found to be safe and feasible for adults with migraines, showing excellent adherence and no adverse events during the study with 19 participants.

While the study did not find statistically significant changes in migraine frequency, MBSR participants experienced shorter headache duration and improved self-efficacy and mindfulness, suggesting potential benefits that warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation for migraines: a pilot randomized controlled trial. Wells, RE., Burch, R., Paulsen, RH., et al.[2022]

A study of 401 participants with migraines found that most preferred in-person or smartphone-based behavioral therapies for migraine prevention, rather than telephone-based options.

Despite the effectiveness of these therapies, many participants were not willing to pay out of pocket for them, indicating a need for insurance coverage to increase utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Therapy Preferences in People With Migraine. Minen, MT., Jalloh, A., Begasse de Dhaem, O., et al.[2021]

In a study of 23 patients with migraine headaches, those who received biofeedback-assisted relaxation therapy experienced greater reductions in pain and medication use compared to those who relaxed on their own.

The biofeedback group also showed significant decreases in cerebral blood flow velocity in the middle cerebral artery, indicating a potential mechanism for how this therapy alleviates migraine symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of biofeedback-assisted relaxation on migraine headache and changes in cerebral blood flow velocity in the middle cerebral artery. McGrady, A., Wauquier, A., McNeil, A., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness and headache: A "new" old treatment, with new findings. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mechanisms of mindfulness in patients with migraine: Results of a qualitative study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness in migraine: A narrative review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Multimodal biofeedback in the treatment of migraine. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M). [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Meditation for migraines: a pilot randomized controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Behavioral Therapy Preferences in People With Migraine. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of biofeedback-assisted relaxation on migraine headache and changes in cerebral blood flow velocity in the middle cerebral artery. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation has Benefits for Migraine Sufferers. [2021]