Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 1:37 PM
Study NCT ID:
NCT06571032
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "CRS-R scores 6 months after the patient's discharge", 'timeFrame': '6 months', 'description': 'Using the COMA RECOVERY SCALE-REVISED (CRS-R) to evaluate the condition of the patient 6 months after discharge and the effectiveness of neuroelectrial stimulation. The minimum and maximum values of CRS-R is 0 and 23 and higher scores mean a better outcome.'}], 'secondaryOutcomes': [{'measure': 'CRS-R scores during hospitalization', 'timeFrame': '3 months', 'description': 'Using the COMA RECOVERY SCALE-REVISED (CRS-R) to evaluate the condition of the patient during hospitalization and the effectiveness of neuroelectrial stimulation. The minimum and maximum values of CRS-R is 0 and 23 and higher scores mean a better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electroencephalography', 'Severe traumatic brain injuries'], 'conditions': ['Brain Injuries']}, 'descriptionModule': {'briefSummary': "The goal of this observational retrospective study is to evaluate the electroencephalography (EEG)'s poficiency in the treatment of neuroelectric stimulation in patients with severe traumatic brain injuries (TBI).\n\nThe main questions it aims to answer are:\n\n1. Whether EEG of patients with severe TBI will change after they receiving neuroelectrial stimulation? If yes, how does it change?\n2. How can EEG be used to evaluate the condition of patients with severe TBI?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients have severe TBI and receive neuroelectral stimulation.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 7 days after severe traumatic brain injuries (GCS score 3-8);\n* Over 18 years old, regardless of gender;\n* The patient's legal representative is informed and voluntarily signs the consent form.\n\nExclusion Criteria:\n\n* Unstable vital signs;\n* History of mental disorders or neurodegenerative diseases;\n* Uncontrolled epilepsy;\n* Severe arrhythmias or patients with implanted cardiac pacemakers;\n* Various conditions that interfere with scalp EEG collection;\n* Pregnant women."}, 'identificationModule': {'nctId': 'NCT06571032', 'briefTitle': 'Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Evaluation of Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries: A Prospective Study', 'orgStudyIdInfo': {'id': 'LY2024-007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Consicousness improved group', 'description': 'After receiving neuroelectrial stimulation, the patients with severe TBI have the consciousness improvement (CRS-R score is higher than before).'}, {'label': 'Consicousness unimproved group', 'description': 'After receiving neuroelectrial stimulation, the patients with severe TBI have no consciousness improvement (CRS-R score remains the same as before).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '201114', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junfeng Feng, Ph.D.', 'role': 'CONTACT', 'email': 'fengjfmail@163.com', 'phone': '+8613611860825'}, {'name': 'Junfeng Feng, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Weiji Weng, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ru Gong, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zhenghui He, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zixuan Ma, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daiwen Zhang, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Weiji Weng, Ph.D.', 'role': 'CONTACT', 'email': 'zigzagweng@163.com', 'phone': '+8613916673435'}], 'overallOfficials': [{'name': 'Junfeng Feng, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Brain Injury Center', 'investigatorFullName': 'Junfeng Feng', 'investigatorAffiliation': 'RenJi Hospital'}}}}