Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-02 @ 2:06 AM
Study NCT ID:
NCT06695156
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-06
First Post:
2024-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: A Single Arm Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'It is a pilot study investigating the impact of Transcendental Meditation on migraine as a basis for a larger randomized control study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2024-11-02', 'studyFirstSubmitQcDate': '2024-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and functionality', 'timeFrame': '6 Months', 'description': 'Frequency and functionality will be measured by the data recorded in the migraine App.'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Meditation', 'Transcendental Meditation'], 'conditions': ['Migraine', 'Migraine With or Without Aura']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://ashashristi.wixsite.com/migrainestudy', 'label': 'Migraines and Meditation We are conducting research to see the effect of Transcendental Meditation (TM) on the intensity and frequency of migraines.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of migraine with or without aura, based on ICHD3 criteria\n* 6-14 migraine days/month.\n* ≥ one-year history of migraines starting before the age of 50.\n* ≥ 18 years old or ≤ 60 Years old\n* Willing to attend follow-up sessions.\n* Willing to practice TM twice a day for 20 minutes.\n* Fluent in English.\n\nWilling to continue the same medication without any additional medicine\n\nIn good general health, with no other diseases expected to interfere with the study.\n\nExclusion criteria:\n\n* \\> 60 years old or \\< 18 Years old\n* Already practicing Transcendental Meditation.\n* Pre-diagnosed major systemic illness or unstable medical/psychiatric condition (eg, suicide risk) requiring immediate treatment or that could compromise protocol adherence\n* Medication overuse headache (MOH)\n* Current/planned pregnancy or breastfeeding\n* New prophylactic migraine medicine started within 4 weeks of the screening visit\n* Unwilling to maintain stable migraine medication dosages\n* Failure to complete baseline headache logs.'}, 'identificationModule': {'nctId': 'NCT06695156', 'briefTitle': 'Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: A Single Arm Study', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi International University'}, 'officialTitle': 'Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: A Single Arm Study', 'orgStudyIdInfo': {'id': 'MIU002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exploring the Effect of the Transcendental Meditation® Technique on Migraine', 'interventionNames': ['Behavioral: Meditation']}], 'interventions': [{'name': 'Meditation', 'type': 'BEHAVIORAL', '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 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', 'armGroupLabels': ['Exploring the Effect of the Transcendental Meditation® Technique on Migraine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown Headache Center and DC area', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Dr. Fred T Travis, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maharishi International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This is a pilot study, and data will be used to design a larger RCT study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Brain Center and PhD Chair of the Department of Maharishi Vedic Science at Maharishi University of Management', 'investigatorFullName': 'Fred Travis', 'investigatorAffiliation': 'Maharishi International University'}}}}