Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05415020
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2022-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determining the Utility of a Behavioral Intervention in Chronic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D020773', 'term': 'Headache Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Headache self-efficacy', 'timeFrame': '12 weeks', 'description': 'Headache self-efficacy measured using the validated Headache Self-Efficacy Questionnaire. Scores range from 25 to 175. Higher scores mean a better outcome.'}, {'measure': 'Levels of candidate biomarkers', 'timeFrame': '12 weeks', 'description': 'Using mass spectrometry, serum levels of candidate biomarkers acryloyl-CoA, glutaminylhistidine, HABP2 will be compared at baseline and end of study (end of week-12)'}], 'primaryOutcomes': [{'measure': 'Number of Interested Participants that are Enrolled', 'timeFrame': '12 weeks', 'description': 'Recruitment rate (Feasibility Outcome)'}, {'measure': 'Acceptability', 'timeFrame': '12 weeks', 'description': 'Retention rate'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline monthly migraine frequency', 'timeFrame': '12 weeks', 'description': 'Change in the mean of monthly migraine frequency'}, {'measure': 'Migraine severity', 'timeFrame': '12 weeks', 'description': 'severity of migraine attacks rated from 0 to 10'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine Disorders', 'Headache', 'Lifestyle'], 'conditions': ['Migraine', 'Headache', 'Migraine Disorders', 'Chronic Migraine', 'Lifestyle Factors', 'Headache Disorders']}, 'referencesModule': {'references': [{'pmid': '34357593', 'type': 'BACKGROUND', 'citation': 'Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6.'}, {'pmid': '32973989', 'type': 'BACKGROUND', 'citation': 'Woldeamanuel YW, Sanjanwala BM, Cowan RP. Endogenous glucocorticoids may serve as biomarkers for migraine chronification. Ther Adv Chronic Dis. 2020 Jul 21;11:2040622320939793. doi: 10.1177/2040622320939793. eCollection 2020.'}, {'pmid': '32071349', 'type': 'BACKGROUND', 'citation': 'Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038/s41598-020-59738-1.'}, {'pmid': '30468246', 'type': 'BACKGROUND', 'citation': 'Woldeamanuel YW, DeSouza DD, Sanjanwala BM, Cowan RP. Clinical Features Contributing to Cortical Thickness Changes in Chronic Migraine - A Pilot Study. Headache. 2019 Feb;59(2):180-191. doi: 10.1111/head.13452. Epub 2018 Nov 23.'}, {'pmid': '28017235', 'type': 'BACKGROUND', 'citation': 'Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017 Jan 15;372:307-315. doi: 10.1016/j.jns.2016.11.071. Epub 2016 Dec 3.'}, {'pmid': '26810728', 'type': 'BACKGROUND', 'citation': 'Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007/s00415-016-8031-5. Epub 2016 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have chronic migraine for a minimum of 1-year\n* aged 18 years and older\n\nExclusion Criteria:\n\n* other headache disorders including secondary headache disorders\n* children younger than 18 years old\n* current pregnancy'}, 'identificationModule': {'nctId': 'NCT05415020', 'acronym': 'RLB', 'briefTitle': 'Determining the Utility of a Behavioral Intervention in Chronic Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine', 'orgStudyIdInfo': {'id': '24-004888'}, 'secondaryIdInfos': [{'id': 'K01NS124911', 'link': 'https://reporter.nih.gov/quickSearch/K01NS124911', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Therapy Group', 'interventionNames': ['Behavioral: Lifestyle Behavior Protocol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Attention Placebo Group', 'interventionNames': ['Behavioral: Sham Behavior Protocol']}], 'interventions': [{'name': 'Lifestyle Behavior Protocol', 'type': 'BEHAVIORAL', 'description': 'Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks', 'armGroupLabels': ['Virtual Therapy Group']}, {'name': 'Sham Behavior Protocol', 'type': 'BEHAVIORAL', 'description': 'Virtual training on the disease of migraine and how migraine can progress to chronic migraine.', 'armGroupLabels': ['Attention Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dakota Hohenwalter', 'role': 'CONTACT', 'email': 'hohenwalter.dakota@mayo.edu', 'phone': '480-574-1416'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'centralContacts': [{'name': 'Dr. Yohannes W. Woldeamanuel, MD', 'role': 'CONTACT', 'email': 'Woldeamanuel.YohannesWoubishet@mayo.edu', 'phone': '650-933-3560'}, {'name': 'Migraine Study', 'role': 'CONTACT', 'email': 'azmigrainetrial@mayo.edu', 'phone': '480-342-1385'}], 'overallOfficials': [{'name': 'Dr. Yohannes W. Woldeamanuel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'starting 6 months after publication, for 5 years', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yohannes Woubishet Woldeamanuel', 'investigatorAffiliation': 'Mayo Clinic'}}}}