Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: A Single Arm Study

Maharishi International University

Status

Active, not recruiting

Conditions

Migraine

Migraine With or Without Aura

Treatments

Behavioral: Meditation

Study type

Interventional

Funder types

Other

Identifiers

NCT06695156

MIU002

Details and patient eligibility

About

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.

Full description

The objective of this study is to assess the safety, feasibility, and effects of the practice of the Transcendental Meditation technique in adults with migraines. This study will involve 30 participants recruited from migraine treatment facilities and migraine support groups in the US. The study will span three months, with all participants practicing Transcendental Meditation (TM) while continuing their usual lifestyle and medication regimen. Pre-data will be collected through symptom analysis, headache patterns, and evaluation questionnaires. All potential subjects will keep a daily migraine diary for 30 days before inclusion in the study, both to assess migraine status and to adhere to study protocols during the study. All the subjects will receive TM instruction, followed by bi-weekly group meetings and one-on-one sessions for 3 months to monitor progress and ensure correct practice.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of migraine with or without aura, based on ICHD3 criteria
6-14 migraine days/month.
≥ one-year history of migraines starting before the age of 50.
≥ 18 years old or ≤ 60 Years old
Willing to attend follow-up sessions.
Willing to practice TM twice a day for 20 minutes.
Fluent in English.

Willing to continue the same medication without any additional medicine

In good general health, with no other diseases expected to interfere with the study.

Exclusion criteria

> 60 years old or < 18 Years old
Already practicing Transcendental Meditation.
Pre-diagnosed major systemic illness or unstable medical/psychiatric condition (eg, suicide risk) requiring immediate treatment or that could compromise protocol adherence
Medication overuse headache (MOH)
Current/planned pregnancy or breastfeeding
New prophylactic migraine medicine started within 4 weeks of the screening visit
Unwilling to maintain stable migraine medication dosages
Failure to complete baseline headache logs.