MigraineNCT06695156
Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency, Intensity, and Functionality: A Single-Arm Study
A study testing Meditation in people with Migraine and Migraine With or Without Aura, run by Maharishi International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine, Migraine With or Without Aura
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- > 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown Headache Center and DC area
Washington D.C., District of Columbia, 20036
About this study
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.
Read the 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
- Being tested
- Meditation
- Keywords
- Migraine, Meditation, Transcendental Meditation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exploring the Effect of the Transcendental Meditation® Technique on Migraine | Experimental | Not described Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and functionality
Frequency and functionality will be measured by the data recorded in the migraine App.
Measured: 6 Months
The Migraine Disability Assessment (MIDAS) to measure frequency and functionality.
Measured: 6 Months
Migraine Specific Quality of Life Questionnaire (MSQ), version 2.1 to measure impact on Quality of Life
Measured: 6 Months
Questionnaire (MSQ), version 2.1 to measure impact on functionality.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start28 Aug 2024
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- It is a pilot study investigating the impact of Transcendental Meditation on migraine as a basis for a larger randomized control study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fred Travis, Maharishi International University
- Investigators
- Dr. Fred T Travis, PhD, Study chair, Maharishi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695156
- Sponsor's protocol ID
- MIU002
- Status last verified
- Jul 2026
- First submitted
- 2 Nov 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a pilot study, and data will be used to design a larger RCT study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency, Intensity, and Functionality: A Single-Arm Study
- ClinicalTrials.gov ID
- NCT06695156
- Acronym / sponsor ID
- MIU002
- Conditions
- Migraine, Migraine With or Without Aura
- Keywords
- Migraine, Meditation, Transcendental Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a pilot study investigating the impact of Transcendental Meditation on migraine as a basis for a larger randomized control study.
| Arm | Type | Receives |
|---|---|---|
| Exploring the Effect of the Transcendental Meditation® Technique on Migraine | Experimental | Behavioral: Meditation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationThe 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 | Behavioural | Exploring the Effect of the Transcendental Meditation® Technique on Migraine |
Primary outcome
Frequency and functionality
Time frame: 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.
Time frame: 6 Months
Migraine Specific Quality of Life Questionnaire (MSQ), version 2.1 to measure impact on Quality of Life
Time frame: 6 Months
Questionnaire (MSQ), version 2.1 to measure impact on functionality.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Migraines and Meditation We are conducting research to see the effect of Transcendental Meditation (TM) on the intensity and frequency of migraines.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This is a pilot study, and data will be used to design a larger RCT study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Fred T Travis, PhD study chair
Maharishi International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Migraine and Migraine With or Without Aura, run by Maharishi International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and functionality (time frame: 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.