Clinical trial NCT06695156: Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: a Single Arm Study
Official title: Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: a Single Arm Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Migraine with or Without Aura
Keywords: Migraine
Meditation
Transcendental Meditation
Lead sponsor: Maharishi International University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: It is a pilot study investigating the impact of Transcendental Meditation on migraine as a basis for a larger randomized control study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency and functionality
timeFrame: 6 Months
measure: The Migraine Disability Assessment (MIDAS) to measure frequency and functionality.
timeFrame: 6 Months
measure: Migraine Specific Quality of Life Questionnaire (MSQ), version 2.1 to measure impact on Quality of Life
timeFrame: 6 Months
measure: Questionnaire (MSQ), version 2.1 to measure impact on functionality.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown Headache Center and DC area
state: District of Columbia
Study officials:
affiliation: Maharishi International University
name: Dr. Fred T Travis, PhD
role: STUDY_CHAIR
References: