Brain InjuriesCPM-BrainNCT07198490
Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring
An observational study of Brain Injuries, run by Xingui Dai.
Trial summary
This is a prospective, observational cohort study aimed at constructing a machine learning-based prognostic model for severe brain-injured patients. The study will synchronously collect continuous glucose monitoring (CGM), electroencephalography (EEG), near-infrared spectroscopy (fNIRS), transcranial Doppler (TCD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2026
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of adult patients (≥18 years old) admitted to the Intensive Care Unit (ICU) of Chenzhou First People's Hospital with a diagnosis of brain injury. This includes patients with:Severe Traumatic Brain Injury (TBI), Expected ICU stay >72 hours,Informed consent from legal surrogate.
Who may be able to join
- Diagnosis of severe TBI, large-volume stroke, or HIE
- Expected ICU stay >72 hours
- Informed consent from legal surrogate
Who cannot join
- Terminal organ failure
- Pre-existing severe neurological disease
- Skull defect preventing monitoring
- Pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring: A Prospective Observational Study
This is a prospective, observational cohort study aimed at constructing a machine learning-based prognostic model for severe brain-injured patients. The study will synchronously collect continuous glucose monitoring (CGM), electroencephalography (EEG), near-infrared spectroscopy (fNIRS), transcranial Doppler (TCD), and serum neuronal injury biomarkers (NSE, S100β) within 72 hours post-injury. The goal is to investigate the correlation between glycemic variability (GV) and neurological function and to develop an integrated model for early prediction of 3-6 month neurological outcomes (GOSE score).
Read the detailed description
This study intends to enroll 50 adult patients with brain injury admitted to the ICU. Multimodal monitoring data will be collected prospectively. Machine learning algorithms will be used to integrate the data and build a predictive model. The study will test whether integrated metabolic-neurological monitoring outperforms traditional single-parameter prognostic methods.
- Conditions
- Brain Injuries
- Keywords
- continuous glucose monitoring,Neurological Multimodal Monitoring,Brain Injury,Intensive Care Unit
- Medical subject headings
- Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale Extended (GOSE)
Neurological outcome at 3 and 6 months assessed by Glasgow Outcome Scale Extended (GOSE)
Measured: 3 and 6 months
Secondary outcomes (1)
28 days mortality
all cause mortality at days 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Xingui Dai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingui Dai, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198490
- Sponsor's protocol ID
- Chenzhou People's Hospital
- Acronym
- CPM-Brain
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jones S, Schwartzbauer G, Jia X. Brain Monitoring in Critically Neurologically Impaired Patients. Int J Mol Sci. 2016 Dec 27;18(1):43. doi: 10.3390/ijms18010043.
PubMed 28035993Miller C, Armonda R; Participants in the International Multi-disciplinary Consensus Conference on Multimodality Monitoring. Monitoring of cerebral blood flow and ischemia in the critically ill. Neurocrit Care. 2014 Dec;21 Suppl 2:S121-8. doi: 10.1007/s12028-014-0021-9.
PubMed 25208667Gandee R, Miller C. Multimodality Monitoring: Toward Improved Outcomes. Semin Respir Crit Care Med. 2017 Dec;38(6):785-792. doi: 10.1055/s-0037-1608774. Epub 2017 Dec 20.
PubMed 29262436
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07198490
- Acronym / sponsor ID
- CPM-Brain / Chenzhou People's Hospital
- Conditions
- Brain Injuries
- Keywords
- continuous glucose monitoring,Neurological Multimodal Monitoring,Brain Injury,Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xingui DaiUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, observational cohort study aimed at constructing a machine learning-based prognostic model for severe brain-injured patients. The study will synchronously collect continuous glucose monitoring (CGM), electroencephalography (EEG), near-infrared spectroscopy (fNIRS), transcranial Doppler (TCD), and serum neuronal injury biomarkers (NSE, S100β) within 72 hours post-injury. The goal is to investigate the correlation between glycemic variability (GV) and neurological function and to develop an integrated model for early prediction of 3-6 month neurological outcomes (GOSE score).
Detailed description
This study intends to enroll 50 adult patients with brain injury admitted to the ICU. Multimodal monitoring data will be collected prospectively. Machine learning algorithms will be used to integrate the data and build a predictive model. The study will test whether integrated metabolic-neurological monitoring outperforms traditional single-parameter prognostic methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (≥18 years old) admitted to the Intensive Care Unit (ICU) of Chenzhou First People's Hospital with a diagnosis of brain injury. This includes patients with:Severe Traumatic Brain Injury (TBI), Expected ICU stay >72 hours,Informed consent from legal surrogate.
Key inclusion criteria (3 listed)
- Diagnosis of severe TBI, large-volume stroke, or HIE
- Expected ICU stay >72 hours
- Informed consent from legal surrogate
Key exclusion criteria (4 listed)
- Terminal organ failure
- Pre-existing severe neurological disease
- Skull defect preventing monitoring
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glasgow Outcome Scale Extended (GOSE)
Time frame: 3 and 6 months
Neurological outcome at 3 and 6 months assessed by Glasgow Outcome Scale Extended (GOSE)
1 secondary outcome
28 days mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 28035993Jones S, Schwartzbauer G, Jia X. Brain Monitoring in Critically Neurologically Impaired Patients. Int J Mol Sci. 2016 Dec 27;18(1):43. doi: 10.3390/ijms18010043.
- Background: PubMed 25208667Miller C, Armonda R; Participants in the International Multi-disciplinary Consensus Conference on Multimodality Monitoring. Monitoring of cerebral blood flow and ischemia in the critically ill. Neurocrit Care. 2014 Dec;21 Suppl 2:S121-8. doi: 10.1007/s12028-014-0021-9.
- Results publication: PubMed 29262436Gandee R, Miller C. Multimodality Monitoring: Toward Improved Outcomes. Semin Respir Crit Care Med. 2017 Dec;38(6):785-792. doi: 10.1055/s-0037-1608774. Epub 2017 Dec 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Xingui Dai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingui Dai (18175708210, 20685562@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale Extended (GOSE) (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07198490, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.