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

NCT ID: NCT06695156

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-28

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine Migraine With or Without Aura

Keywords

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Migraine Meditation Transcendental Meditation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

It is a pilot study investigating the impact of Transcendental Meditation on migraine as a basis for a larger randomized control study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exploring the Effect of the Transcendental Meditation® Technique on Migraine

Group Type EXPERIMENTAL

Meditation

Intervention Type 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

Interventions

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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 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maharishi International University

OTHER

Sponsor Role lead

Responsible Party

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Fred Travis

Director, Brain Center and PhD Chair of the Department of Maharishi Vedic Science at Maharishi University of Management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Fred T Travis, PhD

Role: STUDY_CHAIR

Maharishi International University

Locations

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Georgetown Headache Center and DC area

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

Site Status

Countries

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United States

Related Links

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https://ashashristi.wixsite.com/migrainestudy

Migraines and Meditation We are conducting research to see the effect of Transcendental Meditation (TM) on the intensity and frequency of migraines.

Other Identifiers

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MIU002

Identifier Type: -

Identifier Source: org_study_id