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

NCT06469827 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-567
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

severe traumatic brain injury; multimodal imaging; brain injury recovery; neuroregulation; disorder of consciousness

Outcome Measures

Primary Outcomes (3)

• Full Outline of Unresponsiveness, FOUR

  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.

  At 0,2,4,6,8, and 10 days after treatment

• Sensory Modality Assessment and Rehabilitation Technique, SMART

  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.

  At 0,2,4,6,8, and 10 days after treatment

• Coma Recovery Scale Revised, CRS-R

  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

  At 0,2,4,6,8, and 10 days after treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• GCS 3-8 points
• Loss of consciousness greater than 6 hours or consciousness and coma greater than 6 hours within 24 hours after injury

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Ankang Central Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Zhuonan Wang

CONTACT

15332359525; wangzhuonan@xjtu.edu.cn

Jiawen Hu

CONTACT

15291910551; hujiawen@stu.xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)