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

Not Applicable

Recruiting

• Conditions: Migraine; Migraine with or Without Aura

• Registration Number: NCT06695156
• Lead Sponsor: Maharishi International University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-16
• Study First Posted: 2024-11-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Study Start: 2025-05
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency and functionality	6 Months	Frequency and functionality will be measured by the data recorded in the migraine App.
The Migraine Disability Assessment (MIDAS) to measure frequency and functionality.	6 Months
Migraine Specific Quality of Life Questionnaire (MSQ), version 2.1 to measure impact on Quality of Life	6 Months
Questionnaire (MSQ), version 2.1 to measure impact on functionality.	6 months

Trial Locations

Locations (1)

Georgetown Headache Center and DC area; 🇺🇸 Washington, District of Columbia, United States