Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT01152632
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2010-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) 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': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2010-06-27', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of headache frequency', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acupuncture', 'migraine', 'specific acupoints', 'brain network'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '33287704', 'type': 'DERIVED', 'citation': 'Li Z, Zhou J, Lan L, Cheng S, Sun R, Gong Q, Wintermark M, Zeng F, Liang F. Concurrent brain structural and functional alterations in patients with migraine without aura: an fMRI study. J Headache Pain. 2020 Dec 7;21(1):141. doi: 10.1186/s10194-020-01203-5.'}]}, 'descriptionModule': {'briefSummary': 'Selecting acupoints along meridians is the predominant principle in acupuncture treatment, and it is also considered to ensure acupuncture efficacy. This experiment is to investigate whether specific brain networks gradually come in formation in accordance with this kind of acupoint selection methods.', 'detailedDescription': 'Every participants in the four intervention groups will go through functional magnetic imaging (fMRI) scan four times: the 1st scan will be performed at their baselines; the 2nd scan will be done after 2 courses (10 times) acupuncture treatment; the 3rd scan will be performed when the 4 courses end; the 4th scan will be operated after three-month enrollment.\n\nVolunteers in waiting list group will undergo the above scans at the same time points in exception of acupuncture treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of non-aura Migraine formulated by the international headache society in 2004\n\nExclusion Criteria:\n\n* people with other types of headache\n* people with organic cerebral disorders\n* people with primary disorders\n* people in moderate or severe anxiety or depression\n* people in pregnancy'}, 'identificationModule': {'nctId': 'NCT01152632', 'briefTitle': 'Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': 'Acupuncture Treatment for Migraine: a Functional Magnetic Resonance Imaging Study', 'orgStudyIdInfo': {'id': '30930112/C190301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'specific points of Bladder meridian and Shanjiao meridian', 'description': 'In traditional Chinese acupuncture theory, Bladder meridian and Shanjiao meridian have been considered as the main pathological meridian location of migraine. Meanwhile, specific points on both meridians have been used widely in its treatment for a long time.', 'interventionNames': ['Other: manual acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'non-specific points of Bladder meridian and Shanjiao meridian', 'description': 'Non-specific points of Shaoyang meridians are also used in cure of migraine. It is conventionally thought to be less effective using non-specific points than specific ones.', 'interventionNames': ['Other: manual acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'specific points of Stomach meridian', 'description': 'Specific points of Stomache meridian for migraine were searched in Chinese ancient data. And this group is set to compare with specific points of Shaoyang meridians for their possible different brain networks.', 'interventionNames': ['Other: manual acupuncture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'non-acupoints', 'description': 'Three non-acupoints were chosen,two of which were located on the arm and one one the leg.', 'interventionNames': ['Other: manual acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'waiting list'}], 'interventions': [{'name': 'manual acupuncture', 'type': 'OTHER', 'otherNames': ['acupuncture'], 'description': 'thirty minutes duration every time, five times per week for one course, a total four courses', 'armGroupLabels': ['non-acupoints', 'non-specific points of Bladder meridian and Shanjiao meridian', 'specific points of Bladder meridian and Shanjiao meridian', 'specific points of Stomach meridian']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610075', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu University of Traditional Chinese Medicine', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Fanrong Liang, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Chengdu University of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}