Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05334927
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-06-22
First Post:
2022-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
China HeadAche DIsorders RegiStry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D018781', 'term': 'Tension-Type Headache'}, {'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}], 'ancestors': [{'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood;serum; Saliva; Feces; Urine; Cerebral Spinal Fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-20', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache Days', 'timeFrame': 'long term: 10 years', 'description': 'The number of days of headache is the number of days in which headache occurs.'}, {'measure': 'MRI change', 'timeFrame': 'long term: 10 years', 'description': 'Patients will accept MRI scans will be done at baseline and once per year.'}, {'measure': 'Genetic analysis of familial headache', 'timeFrame': '1 year', 'description': 'Blood samples will be collected from all participants who consent to participate in the study, for the purposes of genetic analysis of familial headache.'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'long term: 10 years', 'description': 'The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.'}, {'measure': 'Mini-Mental State Exam (MMSE)', 'timeFrame': 'long term: 10 years', 'description': 'The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used in clinical and research settings to assess cognitive function.'}, {'measure': 'Migraine Disability Assessment (MIDAS)', 'timeFrame': 'long term: 10 years', 'description': 'The MIDAS is a 7-item questionnaire designed to quantify headache-related disability over a 3- month period. The MIDAS score is the sum of missed work or school days, days at work or school plus days of household work where productivity was reduced by half or more, missed household work days, and missed non-work activity days due to headaches in the last 3 months.'}, {'measure': 'Generalized Anxiety Disorder (GAD-7)', 'timeFrame': 'long term: 10 years', 'description': 'GAD-7 is a proven, self-administered and concise tool for screening and diagnosing mental health disorders, which has been tested in the field in office practice. The GAD-7 scale score ranges from 0 to 21.'}, {'measure': 'Patient Health Questionnaire (PHQ)-9', 'timeFrame': 'long term: 10 years', 'description': 'The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.'}], 'secondaryOutcomes': [{'measure': 'Social and demographic data, medical history', 'timeFrame': 'long term: 10 years', 'description': 'Social and demographic data, medical and medication history will be collected at initial screening.'}, {'measure': 'Use of Rescue Medication', 'timeFrame': 'long term: 10 years', 'description': 'Frequency of Rescue medication will be collected by eDiary.'}, {'measure': 'Moderate / Severe Headache Days', 'timeFrame': 'long term: 10 years', 'description': 'Moderate / severe headache days are defined as a day in which moderate or severe pain persists for at least 4 hours, or headache lasts for one day after successful medication for acute headache. These definitions allow the use of relatively simple headache diaries. Subjects were required to indicate whether headache was present (yes / no), peak (mild / moderate / severe) severity and duration (\\< 4h or 4h), type of acute drug intake, and response to treatment should also be recorded.'}, {'measure': 'Pain severity', 'timeFrame': 'long term: 10 years', 'description': 'Pain severity were captured through Visual analogue scale (VAS) for pain, a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).'}, {'measure': 'MEG', 'timeFrame': 'long term: 10 years', 'description': 'Patients will accept MEG.'}, {'measure': 'PET', 'timeFrame': 'long term: 10 years', 'description': 'Patients will accept PET scan.'}, {'measure': 'EEG', 'timeFrame': 'long term: 10 years', 'description': 'Patients will accept EEG scan.'}, {'measure': 'Proteomics', 'timeFrame': '1 year', 'description': 'Blood, urine and Cerebrospinal fluid samples will be collected from all participants who consent to participate in the study, for the purposes of Proteomics at baseline and month 12.'}, {'measure': 'Microbiome', 'timeFrame': '1 year', 'description': 'Saliva samples will be collected from all participants who consent to participate in the study, for the purposes of Microbiome at baseline and month 12.'}, {'measure': 'Headache Impact Test (HIT-6)', 'timeFrame': 'long term: 10 years', 'description': "The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function."}, {'measure': 'European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)', 'timeFrame': 'long term: 10 years', 'description': 'EQ-5D-3L is a generic instrument for use as a measure of health status. The EQ-5D-3L consists of 2 components-the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.\n\nThe EQ VAS records the respondent\'s self-rated health on a vertical, VAS where the endpoints are labelled "Best imaginable health state" and "Worst imaginable health state." The scoring range of the EQ VAS is from 0 (worst imaginable health) to 100 (best imaginable health).'}, {'measure': 'Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)', 'timeFrame': 'long term: 10 years', 'description': "The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines."}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'long term: 10 years', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep.'}, {'measure': 'Columbia-Suicide Severity Rating Scale', 'timeFrame': 'long term: 10 years', 'description': 'C-SSRS will be administered to study subjects at each study visit to assess possible suicidal ideation and behavior. Reports of suicidal ideation with intent to act (endorse item 4 or 5) and reports of actual, aborted, or interrupted suicide attempts or a behavior preparatory for making an attempt indicate subjects at high risk for suicide.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache Disorders, Primary', 'Migraine', 'New Daily Persistent Headache', 'Medication Overuse Headache', 'Tension-Type Headache', 'Trigeminal Autonomic Cephalalgia']}, 'referencesModule': {'references': [{'pmid': '41091912', 'type': 'DERIVED', 'citation': 'Xiong Z, Qiu D, Liang J, Li X, Guo Z, Zhang M, Liu G, Gao T, Wang Y. Disrupted functional network topology in tension-type headache: A cross-sectional magnetoencephalography study. Cephalalgia. 2025 Oct;45(10):3331024251386425. doi: 10.1177/03331024251386425. Epub 2025 Oct 15.'}, {'pmid': '38516817', 'type': 'DERIVED', 'citation': 'Wang W, Qiu D, Mei Y, Bai X, Yuan Z, Zhang X, Xiong Z, Tang H, Zhang P, Zhang Y, Yu X, Wang Z, Ge Z, Sui B, Wang Y. Altered functional connectivity of brainstem nuclei in new daily persistent headache: Evidence from resting-state functional magnetic resonance imaging. CNS Neurosci Ther. 2024 Mar;30(3):e14686. doi: 10.1111/cns.14686.'}, {'pmid': '37098469', 'type': 'DERIVED', 'citation': 'Wang W, Yuan Z, Zhang X, Bai X, Tang H, Mei Y, Qiu D, Zhang Y, Zhang P, Zhang X, Zhang Y, Yu X, Sui B, Wang Y. Mapping the aberrant brain functional connectivity in new daily persistent headache: a resting-state functional magnetic resonance imaging study. J Headache Pain. 2023 Apr 26;24(1):46. doi: 10.1186/s10194-023-01577-2.'}]}, 'descriptionModule': {'briefSummary': 'It is planned to include 10000 patients. In the China HeadAche DIsorders RegiStry CHAIRS）, patients aged over 12 years with primary headache and medication-overuse headache(MOH) were collected. The biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 12 years old,Any gender;\n2. The first onset age of primary headache was less than 50 years old(Age \\<65 years at first diagnosis of chronic migraine);\n3. patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3;\n4. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment;\n2. Those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ICHD-3;\n3. According to DSM-V diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.);\n4. Patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year;\n5. Pregnant,planning pregnancy or Lactating women;\n6. Subjects participating in other clinical trials;\n7. Unable to cooperate to complete the follow-up due to geographical or other reasons'}, 'identificationModule': {'nctId': 'NCT05334927', 'acronym': 'CHAIRS', 'briefTitle': 'China HeadAche DIsorders RegiStry', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'China HeadAche DIsorders RegiStry', 'orgStudyIdInfo': {'id': 'KY2022-tt02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medicine Overuse Headache/New Daily Persistent Headache', 'description': 'The first 18 months were followed up once a month,then followed up once at the 24th month,follow-up visits were made annually after 24 months', 'interventionNames': ['Behavioral: Medicine Overuse Headache/New Daily Persistent Headache']}, {'label': 'Chronic Migraine', 'description': 'The patients were followed up at 1, 2, 3, 6, 9, 12, 18 and 24 months,then follow-up visits were made annually', 'interventionNames': ['Behavioral: Chronic Migraine']}, {'label': 'Patients with other types of primary headache', 'description': 'The patients were followed up at 3, 6, 9months', 'interventionNames': ['Behavioral: Patients with other types of primary headache']}], 'interventions': [{'name': 'Medicine Overuse Headache/New Daily Persistent Headache', 'type': 'BEHAVIORAL', 'description': 'At the end of the 24th month visit, the patient is free to choose whether to conduct a face-to-face visit once a year until death.', 'armGroupLabels': ['Medicine Overuse Headache/New Daily Persistent Headache']}, {'name': 'Chronic Migraine', 'type': 'BEHAVIORAL', 'description': 'long-term follow-up', 'armGroupLabels': ['Chronic Migraine']}, {'name': 'Patients with other types of primary headache', 'type': 'BEHAVIORAL', 'description': 'No collection Brain imaging、Cognitive function test、Biological sample', 'armGroupLabels': ['Patients with other types of primary headache']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yong Gang Wang, Doctor', 'role': 'CONTACT', 'email': 'w100yg@163.com', 'phone': '15010066622', 'phoneExt': '086'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yonggang.wang', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}