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NCT07115459Recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
3 Aug 2025
Start date
8 Jan 2024
Primary completion date
31 Dec 2026
Lead sponsor
Xiangya Hospital of Central South University
Diseases
Stroke
NCT number
NCT07115459

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 8 Jan 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Pre-existing severe neurological disorders such as epilepsy, severe encephalopathy, or chronic intracranial conditions (e.g., brain tumors or hydrocephalus).
  • Inability to perform multimodal monitoring due to technical issues (e.g., equipment failure or sensor installation problems).

Other

  • Confirmed brain death on admission or imaging showing irreversible brain herniation.
  • 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.
  • Predicted survival time \<24 hours after admission, or family members choose to withdraw treatment.
  • Refusal to participate in the study by the patient or their legal representative.

Who the study is looking for

  • Aged 18-80 years, no gender restrictions.
  • 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.
  • 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).
  • Able to undergo continuous multimodal monitoring, with an expected ICU stay of ≥72 hours.
  • Informed consent signed by the family or legal representative.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
XiangyaHospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.