Migraine, Migraine With or Without Aura
Conditions
Keywords
Migraine, Meditation, Transcendental Meditation
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.
Interventions
BEHAVIORALMeditation
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
Sponsors
Maharishi International University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Contacts
STUDY_CHAIRDr. Fred T Travis, PhD
Maharishi International University
Outcome results
None listed