Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT06469827
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Full Outline of Unresponsiveness, FOUR', 'timeFrame': 'At 0,2,4,6,8, and 10 days after treatment', 'description': 'The FOUR is an questionnaire which has four main assessments: eye opening, exercise, brain stem reflex, and respiratory function. Each item has a full score of 4 and a total score of 16. Brainstem reflex and respiratory function of FOUR are more sensitive than the GCS language score for predicting mortality risk in ICU patients. The total score was 0 to 16, with lower scores indicating a greater probability of death and disability.'}, {'measure': 'Sensory Modality Assessment and Rehabilitation Technique, SMART', 'timeFrame': 'At 0,2,4,6,8, and 10 days after treatment', 'description': "Assessment of sensory patterns (Sensory Pattern Assessment) and rehabilitation techniques are commonly used in rehabilitation therapy to assess the sensory function and motor ability of patients to develop personalized rehabilitation programs.\n\nSensory pattern assessment usually involves the following steps:\n\n1. Assess the patient's sensory function.\n2. Evaluation sensory conduction pathways.\n3. Evaluation of sensory patterns.\n\nAssessment of rehabilitation techniques usually involves the following steps:\n\n1. Assess the patient's motor function.\n2. Evaluation of exercise mode.\n3. Develop rehabilitation plan."}, {'measure': 'Coma Recovery Scale Revised, CRS-R', 'timeFrame': 'At 0,2,4,6,8, and 10 days after treatment', 'description': 'The CRS-R score is a clinical tool used to assess the level of consciousness in comatose and drowsy patients, fully called the Coma Recovery Scale-Revised. The scoring tool includes 23 items covering different aspects of the patient, such as vision, hearing, motor, response, etc. By scoring these items, medical professionals can assess patient level of awareness and response capacity in order to develop corresponding treatment and rehabilitation plans.\n\nAuditory function scale = for movement to commands. 4-Consistent Movement to Command 3-Reproducible Movement to Command 2-Localization to Sound\n\n1-Auditory Startle 0-None'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe traumatic brain injury', 'multimodal imaging', 'brain injury recovery', 'neuroregulation', 'disorder of consciousness'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about in Evaluation of consciousness impairment in severe TBI and full-cycle neuroregulation based on multimodal imaging. The main question it aims to answer is:\n\n•For the existing examination means of super early neurological consciousness level recognition and function assessment accuracy of poor technical bottleneck, different period individual target brain space positioning difficulties and single rehabilitation technology of whole cycle rehabilitation system, with severe TBI patients as the research object.', 'detailedDescription': 'Brain trauma (traumatic brain injury, TBI) is one of the most common acute and severe diseases in neurosurgery. It has the characteristics of high disability rate and high mortality rate, and has become a major global medical and public health problem. Disorder of consciousness (Disorder of consciousness, DOC) is one of the most common clinical manifestations in the early stage of severe TBI patients with coma. Long-term DOC is the main manifestation of poor prognosis and can cause disability or death. Up to 43% of patients diagnosed with vegetative patients were reclassified as minimal consciousness. How to realize the accurate assessment of DOC population consciousness state, strengthen the early identification and functional assessment of people with severe TBI, and establish the whole-process rehabilitation system and management strategy for severe neurological diseases are the main clinical concerns. This project for the existing examination means of super early neurological consciousness level recognition and function assessment accuracy of poor technical bottleneck, different period individual target brain space positioning difficulties and single rehabilitation technology of whole cycle rehabilitation system, with severe TBI patients as the research object.\n\nThe specific research was mainly conducted from the following three aspects: (1) the relationship between EEG qualitative power spectrum typing, quantitative power spectrum index and behavioral scale, and the assessment of early awareness recovery in DOC patients; (2) the auxiliary scheme for ICU based on near-infrared light therapy; (3) the light-magnetic combined neuroregulation strategy for subacute patients based on precise positioning of fMRI in the resting state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population was in patients over 18 years of age with severe TBI. Inclusion Criteria: 1. GCS 3-8 points. 2. Loss of consciousness greater than 6 hours or consciousness and coma greater than 6 hours within 24 hours after injury. Exclusion Criteria: 1. Alcohol consumption, substance abuse during or within the previous 24 hours. 2. Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. GCS 3-8 points\n2. Loss of consciousness greater than 6 hours or consciousness and coma greater than 6 hours within 24 hours after injury\n\nExclusion Criteria:\n\n1. Alcohol consumption, substance abuse during or within the previous 24 hours\n2. Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder\n3. Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder'}, 'identificationModule': {'nctId': 'NCT06469827', 'briefTitle': 'Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging', 'orgStudyIdInfo': {'id': 'XJTU1AF2023LSK-567'}}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuonan Wang, PHD', 'role': 'CONTACT', 'email': 'wangzhuonan@xjtu.edu.cn', 'phone': '15332359525'}], 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Zhuonan Wang', 'role': 'CONTACT', 'email': 'wangzhuonan@xjtu.edu.cn', 'phone': '15332359525'}, {'name': 'Jiawen Hu', 'role': 'CONTACT', 'email': 'hujiawen@stu.xjtu.edu.cn', 'phone': '15291910551'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankang Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}