Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT04008303
Status:
WITHDRAWN
Last Update Posted:
2021-01-14
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Migraine Surgery
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No participants enrolled since this study open. The Primary research member (medical school student) is no longer available to do this study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Frequency', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Frequency\n\n* Number of migraine headaches per day\n* Number of migraine headaches per week'}, {'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Duration', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Duration\n\n-How long the migraine headaches last in minutes'}, {'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Location', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Location\n\n* Area of head that hurts with migraines.\n* Options include front, side, top, and back.'}, {'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Quality', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Quality\n\n* Description of the migraine pain.\n* Options include sharp, stabbing, dull, pulsating, and burning.'}, {'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Severity', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Severity\n\n\\- Migraine headache severity graded on a 0-10 scale, with 10 being the most severe.'}, {'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Laterality', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Laterality\n\n* Side of the head that is impacted with migraine headaches\n* Options include right, left, or both.'}, {'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Associated Symptoms', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Associated symptoms\n\n* Question to record associated symptoms that occur with migraine headaches\n* Options include nausea, vomiting, photophobia, photophobia, and aura symptoms'}, {'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Exacerbating factors', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Exacerbating factors\n\n* Open ended question to record anything that makes the migraine headaches worse.\n* Examples include medications, environmental triggers (light, noise, etc), and lifestyle (stress, exercise, etc)'}, {'measure': 'Change in International Classification of Headache Disorders Diagnostic criteria: Relieving factors', 'timeFrame': '1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative', 'description': 'Relieving factors\n\n* Open ended question to record anything that makes the migraine headaches better.\n* Examples include medications, avoidance of environmental triggers (light, noise, etc), and lifestyle changes (stress avoidance, exercise, etc)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '22288302', 'type': 'BACKGROUND', 'citation': 'Negro A, Rocchietti-March M, Fiorillo M, Martelletti P. Chronic migraine: current concepts and ongoing treatments. Eur Rev Med Pharmacol Sci. 2011 Dec;15(12):1401-20.'}, {'pmid': '25254996', 'type': 'BACKGROUND', 'citation': 'Janis JE, Barker JC, Javadi C, Ducic I, Hagan R, Guyuron B. A review of current evidence in the surgical treatment of migraine headaches. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):131S-141S. doi: 10.1097/PRS.0000000000000661.'}, {'pmid': '7869073', 'type': 'BACKGROUND', 'citation': 'Stewart WF, Simon D, Shechter A, Lipton RB. Population variation in migraine prevalence: a meta-analysis. J Clin Epidemiol. 1995 Feb;48(2):269-80. doi: 10.1016/0895-4356(94)00128-d.'}, {'pmid': '16388337', 'type': 'BACKGROUND', 'citation': "Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring disability in headache disorders with WHO's Classification of Functioning, Disability and Health (ICF). J Headache Pain. 2005 Dec;6(6):429-40. doi: 10.1007/s10194-005-0252-4. Epub 2005 Dec 15."}, {'pmid': '20966820', 'type': 'BACKGROUND', 'citation': 'Guyuron B, Kriegler JS, Davis J, Amini SB. Five-year outcome of surgical treatment of migraine headaches. Plast Reconstr Surg. 2011 Feb;127(2):603-608. doi: 10.1097/PRS.0b013e3181fed456.'}, {'pmid': '28013487', 'type': 'BACKGROUND', 'citation': 'Gfrerer L, Guyuron B. Surgical treatment of migraine headaches. Acta Neurol Belg. 2017 Mar;117(1):27-32. doi: 10.1007/s13760-016-0731-1. Epub 2016 Dec 24.'}, {'pmid': '19644260', 'type': 'BACKGROUND', 'citation': 'Guyuron B, Reed D, Kriegler JS, Davis J, Pashmini N, Amini S. A placebo-controlled surgical trial of the treatment of migraine headaches. Plast Reconstr Surg. 2009 Aug;124(2):461-468. doi: 10.1097/PRS.0b013e3181adcf6a.'}, {'pmid': '10946944', 'type': 'RESULT', 'citation': 'Guyuron B, Varghai A, Michelow BJ, Thomas T, Davis J. Corrugator supercilii muscle resection and migraine headaches. Plast Reconstr Surg. 2000 Aug;106(2):429-34; discussion 435-7. doi: 10.1097/00006534-200008000-00030.'}, {'pmid': '23542247', 'type': 'RESULT', 'citation': 'Lee M, Monson MA, Liu MT, Reed D, Guyuron B. Positive botulinum toxin type a response is a prognosticator for migraine surgery success. Plast Reconstr Surg. 2013 Apr;131(4):751-757. doi: 10.1097/PRS.0b013e3182818b7f.'}, {'pmid': '15622223', 'type': 'RESULT', 'citation': 'Guyuron B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005 Jan;115(1):1-9.'}]}, 'descriptionModule': {'briefSummary': 'Migraines are very common and affect over 35 million Americans a year. Migraines can be painful and affect daily life. The cause of migraine is multifactorial and not completely understood. Treatment usually includes different classes of medications, life style changes, physical therapy, acupuncture, nerve stimulators and avoiding common triggers (like bright lights, certain foods, or loud sounds).\n\nFor some patients, Botox injected into the muscles of the forehead and neck can significantly reduce pain. Unfortunately, this does not provide long-term relief as the effect of Botox lasts for 3 months. Since year 2000 surgery to treat a selected population of migraine patients has been gaining popularity and showing promising results. The surgery reduces the pressure on the peripheral nerves that are believed to cause migraine headaches by resecting the surrounding tissue (bone, fascia, muscle, and arteries). This surgery provides a more long-term and permanent relief.\n\nThe purpose of this study is to follow the effectiveness and outcomes of migraine surgery.', 'detailedDescription': 'Migraines are very common and affect over 35 million Americans a year. Migraines can be painful and affect daily life. The cause of migraine is multifactorial and not completely understood. Treatment usually includes different classes of medications, life style changes, physical therapy, acupuncture, nerve stimulators and avoiding common triggers (like bright lights, certain foods, or loud sounds).\n\nFor some patients, Botox injected into the muscles of the forehead and neck can significantly reduce pain. Unfortunately, this does not provide long-term relief as the effect of Botox lasts for 3 months. Since year 2000 surgery to treat a selected population of migraine patients has been gaining popularity and showing promising results. The surgery reduces the pressure on the peripheral nerves that are believed to cause migraine headaches by resecting the surrounding tissue (bone, fascia, muscle, and arteries). This surgery provides a more long-term and permanent relief.\n\nThe purpose of this study is to follow the effectiveness and outcomes of migraine surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with migraine headaches that meet above inclusion/exclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Cleared by neurology and headache specialists for surgery\n* Patient cleared by neurology for not having medication overuse headaches\n* Patient able to localize a consistent trigger site where the migraines start\n* Patient has been suffering from migraine for more than 2 years\n* Botox injections or nerve blocks have worked for migraine relief in the past\n* Patients formally diagnosed with migraine headaches by a neurologist\n* Migraines impact quality of life per MIDAS survey\n* No history of Mania, Bipolar disorder, Major Dispersive disorder, or suicidal ideation\n\nExclusion Criteria:\n\n* High dose opioid medication use\n* Does not meet criteria for migraine diagnosis\n* History of prior surgery for migraines'}, 'identificationModule': {'nctId': 'NCT04008303', 'briefTitle': 'Outcomes of Migraine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Outcomes of Following Surgical Decompression for the Treatment of Migraine', 'orgStudyIdInfo': {'id': '190993'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with migraines', 'description': 'Patients seen in clinic and assessed with Migraine Headache Diagnostic Criteria to ensure diagnosis.\n\nPatients track the characteristics of migraine headaches for one month before surgery.\n\nAfter this month, patients receive surgery in the operating room for migraine.\n\nAfter surgery, patients track the characteristics of migraine headaches for 3 months.\n\nPatients will then be asked to track the characteristics migraine headaches again at 1 year and 2 years and 5 years after surgery. For these time periods, patients only have to keep track of the characteristics for 1 month intervals.', 'interventionNames': ['Procedure: Migraine surgery']}], 'interventions': [{'name': 'Migraine surgery', 'type': 'PROCEDURE', 'description': 'Surgical decompression of neuromuscular structures causing migraine headaches.', 'armGroupLabels': ['Patients with migraines']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Salam Kassis, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Department of Plastic Surgery', 'investigatorFullName': 'Brian Drolet', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}