Prognostic model for neurocritical patients using multimodal brain monitoring
Official title: Protocol for Developing and Validating a Multimodal Brain Monitoring-Based Prognostic Model for Neurocritical Patients: A Prospective, Observational, Multicenter Cohort Study
Run by Xiangya Hospital of Central South University · NCT07115459 · Data updated 2026-11-12
This study tests a model that uses EEG, TCD, and NIRS data to predict 90-day outcomes (awake, coma, or death) in adults with acute brain injuries in intensive care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | January 8, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07115459 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with acute brain injury requiring multimodal ICU monitoring and a likely ICU stay of at least 72 hours.
✕Probably not a fit
Patients with pre-existing severe neurological disorders or inadequate monitoring data may not benefit from the model.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter observational cohort conducted in China, enrolling adults with acute brain injury such as large stroke, intracranial hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury. Researchers will collect multimodal brain monitoring data (EEG, transcranial Doppler, and near-infrared spectroscopy) within 1–3 days of ICU admission and apply machine learning to develop a prognostic model for 90-day outcomes. The primary aim is to categorize patients as awake, comatose, or deceased to support personalized treatment decisions. No experimental interventions are involved; the study only observes and analyzes data from standard monitoring. Eligible patients are 18–80 years old and require at least 72 hours of ICU monitoring.
Why it matters
Potential benefit: If successful, the model could help clinicians anticipate patient outcomes earlier and tailor care plans accordingly.
How similar studies have gone: Previous work with multimodal monitoring and prognostic modeling in neurocritical care has shown promise, though external validation remains essential.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-80 years, no gender restrictions. 2. Diagnosed with acute brain injury (ABI), including one of the following: large cerebral infarction, supratentorial large-volume intracerebral hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury, with imaging evidence (CT or MRI) supporting the diagnosis. 3. On ICU admission, Glasgow Coma Scale (GCS) eye response = 1 (no eye opening) and motor score ≤ 5 (does not follow commands); or within 48 hours, neurological deterioration with no eye opening and motor score reduced to ≤ 5 (total GCS score ≤ 8). 4. Able to undergo continuous multimodal monitoring, with an expected ICU stay of ≥72 hours. 5. Informed consent signed by the family or legal representative. Exclusion Criteria: 1. Confirmed brain death on admission or imaging showing irreversible brain herniation. 2. Severe trauma unrelated to brain injury (e.g., multiple fractures, spinal cord injuries, or visceral rupture) that may interfere with brain function monitoring or outcome assessment. 3. Pre-existing severe neurological disorders such as epilepsy, severe encephalopathy, or chronic intracranial conditions (e.g., brain tumors or hydrocephalus). 4. Inability to perform multimodal monitoring due to technical issues (e.g., equipment failure or sensor installation problems). 5. Predicted survival time \<24 hours after admission, or family members choose to withdraw treatment. 6. Refusal to participate in the study by the patient or their legal representative.
Where it's running
-
XiangyaHospital of Central South University
Changsha, Hunan, China Recruiting
Study contacts
- Study coordinator: Zhang
- Email: zlzdzlzd@csu.edu.cn
- Phone: +86 731 8975 3999
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.