Clinical trial NCT06469827: Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging
Official title: Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: severe traumatic brain injury
multimodal imaging
brain injury recovery
neuroregulation
disorder of consciousness
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Ankang Central Hospital
First posted: 2024-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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
3. Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder

Primary outcomes:
measure: Full Outline of Unresponsiveness, FOUR
timeFrame: At 0,2,4,6,8, and 10 days after treatment
measure: Sensory Modality Assessment and Rehabilitation Technique, SMART
timeFrame: At 0,2,4,6,8, and 10 days after treatment
measure: Coma Recovery Scale Revised, CRS-R
timeFrame: At 0,2,4,6,8, and 10 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References: