Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging

NCT ID: NCT06469827

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-07-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankang Central Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhuonan Wang

Role: CONTACT

wangzhuonan@xjtu.edu.cn

15332359525

Jiawen Hu

Role: CONTACT

hujiawen@stu.xjtu.edu.cn

15291910551

Facility Contacts

Zhuonan Wang, PHD

Role: primary

wangzhuonan@xjtu.edu.cn

15332359525

Other Identifiers

XJTU1AF2023LSK-567

Identifier Type: -

Identifier Source: org_study_id