Meditation for Migraine

Overseen By Dr. Jamie Grant, EdD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Maharishi International University

Must not be taking: New migraine prophylactics

Disqualifiers: Age, Meditation, Systemic illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This research will explore the effect of the Transcendental Meditation® Technique on migraine intensity and frequency. It will be a single-arm pilot study involving 30 participants recruited from migraine treatment facilities and support groups in the US.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that you continue the same medication without adding any new ones.

What data supports the effectiveness of the treatment Transcendental Meditation® Technique for migraines?

Research suggests that spiritual meditation, which is similar to Transcendental Meditation, can reduce the frequency of migraines and improve mental and spiritual health. This indicates that meditation practices may help manage migraine symptoms. ^{1 2 3 4 5}

Is meditation safe for treating migraines?

Meditation, including types like Transcendental Meditation, is generally considered safe for humans and has been used to help reduce stress and improve overall well-being. ^{3 6 7 8 9}

How is Transcendental Meditation different from other migraine treatments?

Transcendental Meditation (TM) is unique because it is a non-drug, non-invasive technique that involves silently repeating a mantra to settle the mind and reduce stress, which may help alleviate migraine symptoms. Unlike other treatments like medications or transcranial magnetic stimulation, TM focuses on mental relaxation and stress reduction, potentially offering a holistic approach to managing migraines. ^{1 4 9 10 11}

Research Team

Dr. Fred T Travis, PhD

Principal Investigator

Maharishi International University

Eligibility Criteria

This trial is for women who frequently experience migraines and are seeking alternative treatments. Participants will be selected from migraine treatment centers and support groups within the US.

Inclusion Criteria

I experience 6 to 14 migraine days each month.

I am female by birth.

I have been diagnosed with migraine, with or without aura.

Exclusion Criteria

Already practicing Transcendental Meditation

I am not willing to keep my migraine medication doses the same.

Current/planned pregnancy or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Daily migraine diary

Treatment

Participants practice Transcendental Meditation while continuing their usual lifestyle and medication regimen

12 weeks

Bi-weekly group meetings and one-on-one sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• Transcendental Meditation® Technique

Trial Overview The study is testing the Transcendental Meditation® Technique to see if it can reduce the intensity and frequency of migraines in a small group of 30 participants.

Participant Groups

Group I: Exploring the Effect of the Transcendental Meditation® Technique on Migraine Experimental Treatment 1 Intervention

Transcendental Meditation® Technique is already approved in United States, European Union for the following indications:

Approved in United States as Transcendental Meditation Technique for:

• Migraine prevention
• Stress reduction
• Anxiety management

Approved in European Union as Transcendental Meditation Technique for:

• Migraine prevention
• Stress reduction
• Anxiety management

Who Is Running the Clinical Trial?

Maharishi International University

Lead Sponsor

Trials

13

Recruited

1,800+

Findings from Research

Transcranial magnetic stimulation (TMS) has been found effective for the acute treatment of migraines with aura, based on a meta-analysis of five randomized controlled trials involving 313 patients.

However, TMS did not show significant efficacy for chronic migraines, indicating that while it can help in some cases, it may not be a one-size-fits-all solution for all types of migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of transcranial magnetic stimulation on migraine: a meta-analysis of randomized controlled trails. Lan, L., Zhang, X., Li, X., et al.[2022]

In a randomized controlled trial involving 80 migraine patients, the addition of pranayama to standard medical treatment significantly reduced various clinical outcome variables of migraine, including headache severity and duration of episodes.

While both treatment groups showed improvements, the SMT + pranayama group had a more pronounced reduction in headache severity and duration, suggesting that pranayama can effectively supplement standard migraine treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Pranayama as Adjuvant to Medical Treatment on Severity, Frequency, and Duration of Headache in Migraine Patients: An Open-Label Randomized Controlled Trial. Kaushal, A., Padam, A., Sharma, M., et al.[2023]

In a study of 92 participants, those practicing Spiritual Meditation experienced a significant reduction in migraine frequency and decreased usage of analgesic medication compared to other meditation techniques.

While headache severity did not differ among the groups, Spiritual Meditation improved pain tolerance, suggesting it may be an effective non-pharmacological approach for managing migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Different Meditation Types on Migraine Headache Medication Use. Wachholtz, AB., Malone, CD., Pargament, KI.[2022]

Transcranial magnetic stimulation (TMS) has been shown to be effective as an acute treatment for migraine with aura, particularly through single-pulse TMS (sTMS), which disrupts cortical spreading depression, a key mechanism in migraine pathology.

A portable device for sTMS has been developed to allow for outpatient self-treatment of migraines, while repetitive TMS (rTMS) shows potential as a preventive treatment, although more research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic simulation in the treatment of migraine. Lipton, RB., Pearlman, SH.[2021]

In a study of 83 frequent migraine sufferers, those who practiced spiritual meditation experienced significantly greater reductions in migraine frequency, anxiety, and negative emotions compared to those using secular meditation or relaxation techniques.

Participants practicing spiritual meditation also showed improved pain tolerance and increased feelings of self-efficacy and well-being, suggesting that spiritual meditation may be a beneficial intervention for managing migraine-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Migraines and meditation: does spirituality matter? Wachholtz, AB., Pargament, KI.[2022]

Single-pulse transcranial magnetic stimulation (sTMS) has been shown to be a low-risk technique with minimal adverse events, making it a promising option for diagnosing and treating neurological and psychiatric conditions, including migraines.

Extensive clinical experience over two decades indicates that sTMS does not cause harm to brain tissue or neurophysiological function, supporting its safety as a nonpharmacologic treatment for acute migraine headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation for migraine: a safety review. Dodick, DW., Schembri, CT., Helmuth, M., et al.[2010]

In a 24-week randomized controlled trial with 114 migraine patients, acupuncture showed a comparable reduction in migraine days (2.5 days) to metoprolol (2.2 days), suggesting similar efficacy in migraine prevention.

Acupuncture had a higher response rate (61% of patients experienced a >50% reduction in attacks) and fewer reported adverse effects compared to metoprolol, indicating it may be a safer alternative for those who prefer non-drug treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and tolerability of acupuncture compared with metoprolol in migraine prophylaxis. Streng, A., Linde, K., Hoppe, A., et al.[2013]

Behavioral therapy is strongly supported as an effective adjunctive treatment for preventing migraines, while exercise shows modest evidence for reducing migraine frequency.

Nutraceuticals like feverfew, magnesium, and riboflavin have some evidence for migraine prevention, but caution is advised with Petasites due to potential liver toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutraceutical and Other Modalities for the Treatment of Headache. Tepper, SJ.[2016]

Transcranial magnet therapy (TMT) significantly reduced headache intensity in 76.9% of patients with migraine, compared to only 35% in the control group, indicating its effectiveness as a treatment option.

TMT also led to a notable decrease in associated symptoms such as nausea (73.3% of patients), sensitivity to sound (77.8%), and light (81.8%), along with a 47.8% reduction in the use of analgesics, highlighting its potential to improve overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial magnet therapy in comprehensive therapy of migraine]. Bodrova, RA., Karimova, GM., Gumarova, LS., et al.[2022]

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]

References

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

The efficacy of transcranial magnetic stimulation on migraine: a meta-analysis of randomized controlled trails. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Effect of Pranayama as Adjuvant to Medical Treatment on Severity, Frequency, and Duration of Headache in Migraine Patients: An Open-Label Randomized Controlled Trial. [2023]

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

Effect of Different Meditation Types on Migraine Headache Medication Use. [2022]

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

Transcranial magnetic simulation in the treatment of migraine. [2021]

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

Migraines and meditation: does spirituality matter? [2022]

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

Transcranial magnetic stimulation for migraine: a safety review. [2010]

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

Effectiveness and tolerability of acupuncture compared with metoprolol in migraine prophylaxis. [2013]

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

Nutraceutical and Other Modalities for the Treatment of Headache. [2016]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Transcranial magnet therapy in comprehensive therapy of migraine]. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Mindfulness in migraine: A narrative review. [2021]

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

Multimodal biofeedback in the treatment of migraine. [2019]