135 Participants Needed

Neurofeedback Mindfulness for Migraines

FG
MM
Overseen ByMarla Mickleborough, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Saskatchewan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.25678

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.256910

Are You a Good Fit for This Trial?

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
See 1 more

Exclusion Criteria

I have been using a migraine prevention treatment for over 6 months.
I have Raynaud's syndrome or diabetes.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: neurofeedback mindfulnessExperimental Treatment1 Intervention
Group II: Attention TaskActive Control1 Intervention
Group III: Waitlisted GroupActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Mindfulness and headache: A "new" old treatment, with new findings. [2018]
Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. [2022]
Mechanisms of mindfulness in patients with migraine: Results of a qualitative study. [2023]
Mindfulness in migraine: A narrative review. [2021]
Multimodal biofeedback in the treatment of migraine. [2019]
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]
Meditation for migraines: a pilot randomized controlled trial. [2022]
Behavioral Therapy Preferences in People With Migraine. [2021]
Effect of biofeedback-assisted relaxation on migraine headache and changes in cerebral blood flow velocity in the middle cerebral artery. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Mindfulness Meditation has Benefits for Migraine Sufferers. [2021]
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