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RecruitingNCT07115459Updated Sep 17, 2026

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

An observational study in Acute Brain Injury Coma, Neurocritical Care and Cerebral Infarction, sponsored by Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Xiangya Hospital of Central South University · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Multimodal Brain Monitoring
  • Prognostic Model
03

In context

Cerebral Infarction

219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.

This study's planned enrollment of 200 is below the median of 335 across 72 observational studies indexed under Cerebral Infarction.

Browse Cerebral Infarction studies →

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.

Browse Xiangya Hospital of Central South University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Neurocritical patients aged 18-80 years with acute brain injury admitted to the ICU.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. signed by the family or legal representative.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 90-day Outcome Prediction

    The primary outcome is the prediction of patient status at 90 days post-ICU admission, categorized as awake, comatose, or deceased.

    Time frame: 90-day

07

Study locations

1 of 1 sites recruiting
  • XiangyaHospital of Central South University
    Changsha, Hunan 410080, China
    Recruiting
    • Zhang · Contact
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data (IPD) due to privacy, ethical, or regulatory considerations

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.

Of 32 observational studies under Cerebral Infarction, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 167. This study's planned 35 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2025
First posted
Aug 11, 2025
StartActual
Jan 8, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07115459
Lead sponsor
Xiangya Hospital of Central South University
Collaborators
Changsha Fourth Hospital
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Jan 8, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Zhang
Contact
zlzdzlzd@csu.edu.cn
+86 731 8975 3999

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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