Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-23 @ 12:50 PM
Study NCT ID:
NCT03772860
Status:
UNKNOWN
Last Update Posted:
2018-12-11
First Post:
2018-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining the Sympathetic Skin Response of Migraineurs in the Facial Area
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': 'D010775', 'term': 'Photic Stimulation'}, {'id': 'D000161', 'term': 'Acoustic Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-10', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Defining sympathetic skin response in migraineurs', 'timeFrame': 'One year', 'description': 'Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli'}], 'secondaryOutcomes': [{'measure': 'Defining differences between sympathetic skin response in migraineurs', 'timeFrame': 'One year', 'description': 'Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to define the sympathetic skin response of migraineurs in the facial area. This will be achieved by exposing healthy volunteers and migraine patients to various stress stimuli (pain, visual stimulation, auditory stimulation and a mathematical challenge), and recording sympathetic skin response in the facial area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering migraine attending our Neurology Clinic and healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers with no history of any kind of recurrent headache\n* Migraine patients according to ICH3 criteria\n* Migraine patients with more than 1 attack per month\n\nExclusion Criteria:\n\n* Patients with other heart or neurologic diseases\n* Patients with hearing or visual decline\n* Patients taking medication that effects the sympathetic system (except those taking beta blockers for migraine treatment)'}, 'identificationModule': {'nctId': 'NCT03772860', 'briefTitle': 'Defining the Sympathetic Skin Response of Migraineurs in the Facial Area', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Defining the Sympathetic Skin Response of Migraineurs in the Facial Area During the Interictal State: Comparison of Migraine Patients Who Suffer Dominant Left/Right/Bilateral Pain.', 'orgStudyIdInfo': {'id': 'HYMC-113-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress', 'interventionNames': ['Other: Pain stimulation', 'Other: Visual stimulation', 'Other: Auditory stimulation', 'Other: Mental stress']}, {'label': 'Left headache', 'description': 'Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress', 'interventionNames': ['Other: Pain stimulation', 'Other: Visual stimulation', 'Other: Auditory stimulation', 'Other: Mental stress']}, {'label': 'Right headache', 'description': 'Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress', 'interventionNames': ['Other: Pain stimulation', 'Other: Visual stimulation', 'Other: Auditory stimulation', 'Other: Mental stress']}, {'label': 'Bilateral headache', 'description': 'Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress', 'interventionNames': ['Other: Pain stimulation', 'Other: Visual stimulation', 'Other: Auditory stimulation', 'Other: Mental stress']}], 'interventions': [{'name': 'Pain stimulation', 'type': 'OTHER', 'description': 'Pain will be simulated with an electric shock 25 mlAMP over the median nerve', 'armGroupLabels': ['Bilateral headache', 'Healthy volunteers', 'Left headache', 'Right headache']}, {'name': 'Visual stimulation', 'type': 'OTHER', 'description': 'Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds', 'armGroupLabels': ['Bilateral headache', 'Healthy volunteers', 'Left headache', 'Right headache']}, {'name': 'Auditory stimulation', 'type': 'OTHER', 'description': 'Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds', 'armGroupLabels': ['Bilateral headache', 'Healthy volunteers', 'Left headache', 'Right headache']}, {'name': 'Mental stress', 'type': 'OTHER', 'description': 'A mathematical challenge will be displayed on a computer screen that must be quickly solved', 'armGroupLabels': ['Bilateral headache', 'Healthy volunteers', 'Left headache', 'Right headache']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Erel Domany, MD', 'role': 'CONTACT', 'email': 'erel.domany@gmail.com'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Erel Domany, MD', 'role': 'CONTACT', 'email': 'erel.domany@gmail.com', 'phone': '972-52-6134235'}], 'overallOfficials': [{'name': 'Yaron River, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}