Meditation for Migraine

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Transcendental Meditation® Technique can reduce the frequency and intensity of migraines. As a single-arm study, all participants will use this meditation method and report their migraine symptoms. Suitable candidates have experienced migraines for over a year, typically 6-14 days a month, and are willing to meditate twice daily. The study seeks participants who can maintain their current migraine medication and attend follow-up sessions. As an unphased trial, it offers a unique opportunity to explore a non-drug approach to managing migraines.

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 prior data suggests that the Transcendental Meditation® Technique is safe for migraine sufferers?

Research has shown that Transcendental Meditation (TM) is safe for people. A detailed review found that TM reduced symptoms in various groups without causing harm. Another study involving healthcare workers found TM manageable, with no negative effects reported. Overall, studies suggest TM is generally safe and can be practiced without major risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcendental Meditation® Technique for migraines because it offers a non-drug approach to managing this condition. Unlike standard treatments such as triptans or beta-blockers, which can have side effects, this technique focuses on reducing stress and promoting relaxation through meditation. This approach could potentially offer a natural, side-effect-free option for migraine sufferers, aiming to address one of the root causes of migraines—stress. Additionally, it empowers individuals to take a proactive role in their health by incorporating a simple, daily practice that may improve their overall well-being.

What evidence suggests that the Transcendental Meditation® Technique might be an effective treatment for migraines?

Studies have shown that meditation, particularly types requiring active mental focus, can reduce migraine pain and improve mood. This trial will explore the effects of the Transcendental Meditation® Technique on migraines. Research suggests that Transcendental Meditation® might be more effective than simple distraction techniques in reducing the frequency and severity of migraines. Practitioners of this meditation often report fewer headaches and less intense pain. While the exact reasons remain under study, the calming effect of meditation is believed to help manage stress, a common migraine trigger. Overall, meditation appears to be a promising tool for managing migraine symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Dr. Fred T Travis, PhD

Principal Investigator

Maharishi International University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06695156

Exploring the Effect of the Transcendental Meditation ... This research will explore the effect of the Transcendental Meditation® Technique on migraine intensity and frequency. It will be a single-arm pilot study ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8091992/

Distraction is not enough but meditation takes time This suggests that cognitively active forms of meditation are more effective in reducing migraine headache pain and negative mood than distraction techniques.

3. headaches.org headaches.org/prove-to-me-that-meditating-is-going-to-help-me-overcome-migraine/

Prove to Me that Meditating is Going to Help me Overcome ... All we have found are positive results on pain and/or the emotional, cognitive, and other factors that affect those of us with migraine. Here ...

4. mednexus.org mednexus.org/doi/10.4103/0366-6999.228242

Mindfulness Meditation for Primary Headache Pain: A Meta ... Several studies have reported that mindfulness meditation has a potential effect in controlling headaches, such as migraine and tension-type headache; ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0965229918305946

Distraction is not enough but meditation takes time Meditative techniques using active cognitive control are better at reducing migraine frequency, severity, and negative mood compared to distraction techniques.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30357468/

a multi-centre, pragmatic, randomised clinical study We investigated the effectiveness of two mind-body techniques, transcendental meditation (TM) or hypnotherapy (HT), and compared them with progressive muscle ...

7. trial.medpath.com trial.medpath.com/clinical-trial/2b9c821f619abf2e/nct06695156-transcendental-meditation-migraine

Exploring the Effect of the Transcendental Meditation ... The objective of this study is to assess the safety, feasibility, and effects of the practice of the Transcendental Meditation technique in adults with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12028398/

Systematic Review and Meta-Analysis of Transcendental ... TM produced clinically meaningful reductions in PTSD for civilian and military personnel, young and older adults, and for both men and women.

9. ojin.nursingworld.org ojin.nursingworld.org/table-of-contents/volume-28-2023/number-3-september-2023/articles-on-previously-published-topics/impact-of-transcendental-meditation/

The Impact of Transcendental Meditation: Reducing Burnout ... This study aimed to evaluate the feasibility and effectiveness of the Transcendental Meditation (TM) intervention in a sample of 32 healthcare clinicians.