Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT01271634
Status:
UNKNOWN
Last Update Posted:
2011-07-25
First Post:
2011-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observe Abnormal Potential From the Offending Vessel to the Facial Muscles of HFS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019569', 'term': 'Hemifacial Spasm'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2011-01-05', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal Potential From the Offending Vessel to the Facial Muscles', 'timeFrame': 'up to 4 months'}], 'secondaryOutcomes': [{'measure': 'Latency from the root entry zone of facial nerve to the facial muscles', 'timeFrame': 'up to 4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cross-transmission', 'offending vessel'], 'conditions': ['Hemifacial Spasm']}, 'referencesModule': {'references': [{'pmid': '6086858', 'type': 'BACKGROUND', 'citation': 'Moller AR, Jannetta PJ. On the origin of synkinesis in hemifacial spasm: results of intracranial recordings. J Neurosurg. 1984 Sep;61(3):569-76. doi: 10.3171/jns.1984.61.3.0569.'}]}, 'descriptionModule': {'briefSummary': 'The pathophysiologic basis of hemifacial spasm is cross-transmission between different branches of the facial nerve. The hypothesis is that the cross-transmission is mediated by the sympathetic nerve fibers on the surface of the offending artery. The abnormal potential from the offending vessel to the facial muscles will be detected on hemifacial spasm patients, so as to determine if the sympathetic nerve fibers take part in the circuit of cross-transmission.', 'detailedDescription': 'It\'s hypothesized that at the location where the facial nerve is compressed by an artery, ephaptic cross-transmission takes place between the nude facial nerve fibers and the sympathetic nerve fibers on the arterial surface. Thus action potentials could spread indirectly from one facial nerve fiber to several other facial nerve fibers (via the "bridge" of sympathetic fibers), or directly from the sympathetic fibers to facial nerve fibers. The investigators assume this is the electrophysiological basis of hemifacial spasm and its characteristic sign abnormal muscle response (AMR). If an abnormal potential from the offending artery to the facial muscles similar to AMR can be recorded, the hypothesis will be verified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll 20 cases of hemifacial spasm patients who want to undergo microvascular decompression.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the age of 18-65 years old;\n2. with typical hemifacial spasm symptoms;\n3. with typical abnormal muscle response;\n4. preoperative magnetic resonance imaging revealed obvious paraneural artery;\n5. with informed consent.\n\nExclusion Criteria:\n\n1. pregnant or lactating women;\n2. accompanied by other serious diseases, including liver, kidney, cardiovascular diseases;\n3. accompanied by mental illness or severe neurosis;\n4. unable to express the subjective symptoms.'}, 'identificationModule': {'nctId': 'NCT01271634', 'briefTitle': 'Observe Abnormal Potential From the Offending Vessel to the Facial Muscles of HFS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Observation of the Abnormal Potential From the Offending Vessel to the Facial Muscles of Hemifacial Spasm Patients', 'orgStudyIdInfo': {'id': 'xzheng-hfs-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'XinHua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xuesheng Zheng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Xuesheng Zheng', 'oldOrganization': 'XinHua Hospital, Affiliated to Shanghai JiaoTong University School of Medicine'}}}}