Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 8:09 PM
Study NCT ID:
NCT04363658
Status:
UNKNOWN
Last Update Posted:
2020-05-19
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-17', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of glasgow outcome scale in 6 months after shunt operation', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure', 'timeFrame': '6 months'}, {'measure': 'Revised coma recovery scale (CRS-R) in 1 week after shunting', 'timeFrame': '1 week'}, {'measure': 'Modified Ashworth Scale (MAS) in 1 week after shunting', 'timeFrame': '1 week'}, {'measure': 'Revised coma recovery scale (CRS-R) in 1 month after shunting', 'timeFrame': '1 month'}, {'measure': 'Modified Ashworth Scale (MAS) in 1 month after shunting', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuroelectrophysiology', 'hydrocephalus', 'disorder of consciousness'], 'conditions': ['Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with consciousness and muscle tone to a certain extent, and predict the shunt effect of PTH with disorders of consciousness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient age from 16 to 70 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with disorder of consciousness in traumatic brain injury. The presence of hydrocephalus through image examination.\n\nExclusion Criteria:\n\nPatients who cannot tolerate shunt surgery. Sedation maintained by greater than 0.15mg/kg/hour of midazolam or the infusion dose of propofol higher than 4mg/kg/hour.\n\nPatients who are participating in drug research or other clinical trials.'}, 'identificationModule': {'nctId': 'NCT04363658', 'briefTitle': 'Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Efficacy Study of Shunt Operation in Patients With Disorder of Consciousness of Post-traumatic Hydrocephalus (PTH) by Methods of Neuroelectrophysiology', 'orgStudyIdInfo': {'id': '202001015'}}, 'contactsLocationsModule': {'locations': [{'zip': '94566', 'city': 'Pleasanton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jian Wang, master', 'role': 'CONTACT', 'email': '1172268798@qq.com', 'phone': '557-587-4018'}], 'facility': 'Nicolet EEG', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}], 'centralContacts': [{'name': 'Jian Wang, master', 'role': 'CONTACT', 'email': '1172268798@qq.com', 'phone': '15575874018'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}