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Clinical significance of cerebellar function in assessing consciousness and prognosis in patients with traumatic brain injury– a proof of concept research

Clinical significance of cerebellar function in assessing consciousness and prognosis in patients with traumatic brain injury– a proof of concept research

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076526
Enrollment
Unknown
Registered
2023-10-11
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Traumatic brain injury

Interventions

Group TBI:NA

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age greater than 14 years old, with stable vital signs; 2. Confirmed as a new acute stage patient with primary brain injury within the scope of conservative treatment (injury time = 72 hours and = 24 hours), including brain contusion and laceration, diffuse axonal injury, excluding simple secondary brain injury (such as subdural hematoma and/or epidural hematoma); 3. Prior to admission to the hospital due to this illness, there was no old neurological injury (such as cerebral infarction or cerebral hemorrhage) and normal mental state, with no history of epileptic seizures; 4. At the time of inclusion, the GCS score was 5-14 points, and there were no life-threatening comorbidities; 5. The scalp and head structure are intact and can complete EEG collection; 6. Family members are willing to accept this EEG signal extraction and subsequent reconstruction analysis of EEG signals.

Exclusion criteria

Exclusion criteria: 1. Non primary craniocerebral injury, and damage to the brain or cerebellum exceeding 1/4 of its original volume; 2. The head is sunken or the structure is incomplete, and the scalp injury cannot be collected for EEG; 3. Patients and their families have poor medical compliance, cannot cooperate with EEG collection, or have no imaging results; 4. Those with combined injuries or severe intracranial injuries that endanger life, or those with minor injuries without obvious intracranial lesions; 5. Individuals with clear old intracranial lesions or severe extracranial system diseases that affect consciousness; 6. Pregnant or lactating women; 7. Children under the age of 14.

Design outcomes

Primary

MeasureTime frame
cerebellum EEG and neurological functional evaluation on the 90th day after TBI ;

Secondary

MeasureTime frame
cerebellum EEG and neurological functional evaluation on the first week and month after TBI ;cerebellum EEG and imaging examination on the first week and month after TBI ;

Countries

China

Contacts

Public ContactAn Shuo

Tianjin Medical University General Hospital

417163597@qq.com+86 137 5237 1400

Outcome results

None listed

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