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Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring

Protocol for Developing and Validating a Multimodal Brain Monitoring-Based Prognostic Model for Neurocritical Patients: A Prospective, Observational, Multicenter Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07115459
Enrollment
200
Registered
2025-08-11
Start date
2024-01-08
Completion date
2027-12-31
Last updated
2026-09-17

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

Conditions

Acute Brain Injury Coma, Cerebral Infarction, Intracranial Hemorrhages, Neurocritical Care, Severe Traumatic Brain Injury, Subarachnoid Hemorrhage

Keywords

Multimodal Brain Monitoring, Prognostic Model

Brief summary

This study aims to develop and validate a prognostic model for neurocritical patients using multimodal brain monitoring data. By combining data from various monitoring techniques such as EEG, TCD, and NIRS, this model will help predict 90-day outcomes (awake, comatose, or deceased) and support personalized treatment decisions. The study is observational and involves no experimental interventions.

Detailed description

This study is a prospective, observational, multicenter cohort study conducted in China. It focuses on neurocritical patients with acute brain injury, including large cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury. The study will collect multimodal data from EEG, TCD, and NIRS monitoring within 1-3 days of ICU admission. Machine learning algorithms will be used to develop a model predicting 90-day outcomes, categorized as awake, comatose, or deceased. The study population includes patients aged 18-80 years. Exclusion criteria include pre-existing severe neurological disorders, incomplete monitoring data, or withdrawal during the study period.

Interventions

None listed

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER
Changsha Fourth Hospital
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
90-day Outcome Prediction90-dayThe primary outcome is the prediction of patient status at 90 days post-ICU admission, categorized as awake, comatose, or deceased.

Countries

China

Contacts

CONTACTZhang
zlzdzlzd@csu.edu.cn+86 731 8975 3999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026