NCT06695156

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Maharishi International University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Migraine With or Without Aura

Interventions

Type	Name	Description
BEHAVIORAL	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

Timeline

• Start date: 2024-08-28
• Primary completion: 2026-04-30
• Completion: 2026-05-01
• First posted: 2024-11-19
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States