Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sensory Modality Assessment and Rehabilitation Technique, SMART
研究概览
简要总结
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:
•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.
详细描述
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.
The 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •GCS 3-8 points
- •Loss of consciousness greater than 6 hours or consciousness and coma greater than 6 hours within 24 hours after injury
排除标准
- •Alcohol consumption, substance abuse during or within the previous 24 hours
- •Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder
- •Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder
结局指标
主要结局
Sensory Modality Assessment and Rehabilitation Technique, SMART
时间窗: At 0,2,4,6,8, and 10 days after treatment
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. Sensory pattern assessment usually involves the following steps: 1. Assess the patient's sensory function. 2. Evaluation sensory conduction pathways. 3. Evaluation of sensory patterns. Assessment of rehabilitation techniques usually involves the following steps: 1. Assess the patient's motor function. 2. Evaluation of exercise mode. 3. Develop rehabilitation plan.
Full Outline of Unresponsiveness, FOUR
时间窗: At 0,2,4,6,8, and 10 days after treatment
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.
Coma Recovery Scale Revised, CRS-R
时间窗: At 0,2,4,6,8, and 10 days after treatment
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. Auditory function scale = for movement to commands. 4-Consistent Movement to Command 3-Reproducible Movement to Command 2-Localization to Sound 1-Auditory Startle 0-None
次要结局
未报告次要终点