Prognostic value of resting-state fMRI combined with brain injury biomarkers in coma patients with traumatic brain injury

Prognostic value of resting-state fMRI combined with brain injury biomarkers in coma patients with traumatic brain injury and Nomogram prediction model establishment

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000034043

Enrollment

Unknown

Registered

2020-06-21

Start date

2020-06-21

Completion date

Unknown

Last updated

2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury

Interventions

Gold Standard:Clinical outcomes

Index test:resting-state&#32

fMRI&#32

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injury&#32

biomarkers&#32

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with TBI (clear injury history, clinical manifestations, CT, MRI, etc.); 2. GCS score 2t-8, that is, patients with severe craniocerebral injury and coma; 3. Patients with unlimited education; 4. Patients aged 18-75 years; 5. Gender unlimited; 6. Patients whose close relatives agree to conduct the study and sign the informed consent; 7. Patients with spontaneous respiration and stable vital signs; 8. Patients who are allowed to lie flat; 9. The patients with complete limbs and right handedness before injury; 10. Patients who can work normally and communicate with others before injury (fluent in Mandarin).

Exclusion criteria

Exclusion criteria: 1. Comatose patients caused by other reasons (caused by taking drugs by mistake, cerebrovascular disease, hepatic coma, carbon dioxide coma, sedation and / or analgesia and / or sleeping pills, etc.); 2. Patients with severe multiple injuries (except skull fracture, hemopneumothorax, rupture of liver, spleen, pancreas and kidney, etc.); 3. Patients with serious systemic diseases (septicemia, diabetic ketoacidosis, adrenal crisis, etc.); 4. Patients with other nervous and or mental system diseases (intracranial infection, epilepsy, Parkinson's disease, dementia in the brain, mad cow disease, cerebral infarction, multiple sclerosis, depression, schizophrenia, ADHD, etc.); 5. Patients with contraindications of MRI (history of ferromagnetic metal implantation, claustrophobia syndrome); 6. Patients with a history of alcohol and drug abuse.

Design outcomes

Primary

Measure	Time frame
Coma, awake, GCS, GOS-E;SEN, SPE, ACC, AUC of ROC;	—

Countries

China

Contacts

Public ContactJun Zhang, Lun Dong

Clinical Medical College of Yangzhou University, Dalian Medical University

doctorzhang_0221@163.com+86 19962602706

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026