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Completed

NCT Number: NCT06695156

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown Headache Center and DC area

Washington D.C., District of Columbia, 20036, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of migraine with or without aura, based on ICHD3 criteria
  • 4 and above migraine days/month.
  • · Episodic (4-14) vs chronic migraine (15+)
  • ≥ 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.

Treatment and study plan

Meditation

Behavioral

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 male and female 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 use a migraine App for 30 days prior to inclusion in the study, both as a means of assessing migraine status and of ability to adhere to study protocols during the study. In addition, all subjects will take the PHQ-9 to screen for levels of depression that might impair participation in the study. All the subjects will receive TM instruction, followed by bi-weekly

Primary outcomes

  1. Frequency and functionality

    Time frame: 6 Months

    Frequency and functionality will be measured by the data recorded in the migraine App.

  2. The Migraine Disability Assessment (MIDAS) to measure frequency and functionality.

    Time frame: 6 Months

  3. Migraine Specific Quality of Life Questionnaire (MSQ), version 2.1 to measure impact on Quality of Life

    Time frame: 6 Months

  4. Questionnaire (MSQ), version 2.1 to measure impact on functionality.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Maharishi International University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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