Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT03999060
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2019-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trigeminal Brainstem Mapping
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'}], 'ancestors': [{'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': 'D004599', 'term': 'Electric Stimulation Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-06', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-25', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Statistical Parametric Map calculated from the fMRI data on brainstem level', 'timeFrame': 'through study completion, an average of 9 months', 'description': 'At a statistical threshold of T-value 3 we will observe a somatotopical arrangement in the brainstem below the pons:\n\nExpected location for V1: within radius of 10 mm around the MNI coordinates (-1,-48,-75); Expected location for V2: within radius of 10 mm around the MNI coordinates (-4,-47,-69) Expected location for V3: within radius of 10 mm around the MNI coordinates (-1,-46,-66) Expected location for GON: within radius of 10 mm around the MNI coordinates (-1,-45,-64)'}, {'measure': 'Statistical Parametric Map calculated from the fMRI data in the thalamus', 'timeFrame': 'through study completion, an average of 9 months', 'description': 'At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the thalamus:\n\nExpected location for V1: within radius of 10 mm around the MNI coordinates (11,-5,6); Expected location for V2: within radius of 10 mm around the MNI coordinates (13,-11,5) Expected location for V3: within radius of 10 mm around the MNI coordinates (12,-10,5) Expected location for GON: within radius of 10 mm around the MNI coordinates (15,-12,-7)'}, {'measure': 'Statistical Parametric Map calculated from the fMRI data in the insula', 'timeFrame': 'through study completion, an average of 9 months', 'description': 'At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the insula:\n\nExpected location for V1: within radius of 10 mm around the MNI coordinates (38,-15,8); Expected location for V2: within radius of 10 mm around the MNI coordinates (37,-8,-5) Expected location for V3: within radius of 10 mm around the MNI coordinates (39,2,-11) Expected location for GON: within radius of 10 mm around the MNI coordinates (38,-12,-3)'}], 'secondaryOutcomes': [{'measure': 'Statistical Parametric Map calculated from the fMRI data in the cerebellum', 'timeFrame': 'through study completion, an average of 9 months'}, {'measure': 'Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG)', 'timeFrame': 'through study completion, an average of 9 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache Disorders, Primary', 'Migraine']}, 'referencesModule': {'references': [{'pmid': '37203351', 'type': 'DERIVED', 'citation': 'Mehnert J, Basedau H, Sturm LM, Nielsen T, Jensen RH, May A. Functional brainstem representations of the human trigeminal cervical complex. Cephalalgia. 2023 May;43(5):3331024231174862. doi: 10.1177/03331024231174862.'}]}, 'descriptionModule': {'briefSummary': 'To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula can be mapped using functional imaging and BOLD in humans is not known but might play an important role in imaging headache diseases. The aim is to map their somatotopy by random stimulation of V1, V2, V3 and the GON with painful electrical input during acquisition of BOLD-fMRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* suitable fo MRI\n\nExclusion Criteria:\n\n* headache disease\n* psychological disorder\n* pregnancy\n* all exclusion criteria necessary for imaging in a 3 T MRI scanner'}, 'identificationModule': {'nctId': 'NCT03999060', 'briefTitle': 'Trigeminal Brainstem Mapping', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Brainstem Mapping of Nociceptive Trigeminal Input', 'orgStudyIdInfo': {'id': 'TrigeminalBrainstemMapping'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electric Stimulation', 'interventionNames': ['Device: Electric Current Stimulation']}], 'interventions': [{'name': 'Electric Current Stimulation', 'type': 'DEVICE', 'description': 'Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head', 'armGroupLabels': ['Electric Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'UKE', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Arne May, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Group results will be presented at international conferences as well as published in international peer-reviewed journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}