Traumatic Brain InjuryNCT06958406
Neural Mechanism of Cerebrocardiac Syndrome Following Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Cerebrocardiac Syndrome, run by Shanghai 6th People's Hospital at 2 sites in China.
Trial summary
Cerebrocardiac syndrome (CCS), including myocardial injury, arrhythmia or heart failure is one of serious complications of traumatic brain injury (TBI), mostly occurs within seven days after TBI, which directly aggravates the brain damage and affects the prognosis of TBI patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Cerebrocardiac Syndrome
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 10 Aug 2025to 31 Jul 2027
- How long will I take part?
- 6 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Traumatic brain injury patients and healthy volunteers.
Who may be able to join
- Patients with isolated closed head trauma
- Age 18-80 years old
- Admitted to hospital within 24 hours of injury
- Mild or moderate TBI (Glasgow Coma Scale score of 9-15)
- Signed consent form
Who cannot join
- Severe TBI (Glasgow Coma Scale score of 3-8)
- A history of stroke, TBI, intracranial tumor or surgery in the past 1 year
- A history of coronary heart disease, structural heart disease and other primary heart diseases or suspected cardiac symptoms prior to injury
- Causes of abnormal cardiac biomarkers such as renal insufficiency, severe anemia, sepsis, cardiotoxic drugs and so on
- Not suitable for MRI examinations, such as pregnant women and those with metal implants in the body
- Undergo surgery prior to MRI examinations or cardiac testing
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai 6th People's Hospital
Shanghai, 200233
Hao Chen, M.D., Ph.D., 8602164369181 ext. 8405, hao.chen@shsmu.edu.cn
- Recruiting
Shanghai Sixth People's Hospital
Shanghai
About this study
Official title: Lesion-Network Mapping Analysis With Brain Connectomics to Reveal the Neural Mechanisms of Cerebrocardiac Syndrome Following Traumatic Brain Injury
Cerebrocardiac syndrome (CCS), including myocardial injury, arrhythmia or heart failure is one of serious complications of traumatic brain injury (TBI), mostly occurs within seven days after TBI, which directly aggravates the brain damage and affects the prognosis of TBI patients. Accumulative evidences suggest that autonomic nervous system disorder is a key initiation point for CCS, but how TBI affects the specific action patterns is not yet clear. Therefore, elucidating the neural mechanisms of TBI-induced CCS, maintaining the central sympathetic-parasympathetic balance through novel interventions such as noninvasive brain stimulation, may fundamentally block the downstream peripheral mechanism, thus achieving effective prevention and treatment for CCS. Based on the current emerging research in brain connectomics and lesion-symptom mapping, we speculate that cerebral contusions can cause structural or functional disconnection of key nodes in the central autonomic nervous system regulatory network, thereby mediating the occurrence of TBI-induced CCS.
In this study, magnetic resonance imaging (MRI) or functional MRI (fMRI) examinations were performed in patients with mild or moderate TBI with aim to explore the association between structural and functional disconnection caused by cerebral contusion and TBI-induced CCS, and to screen out the neural anatomical structures to predict CCS following TBI, providing therapy targets for prevention and treatment of CCS.
- Conditions
- Traumatic Brain Injury, Cerebrocardiac Syndrome
- Keywords
- traumatic brain injury, cerebrocardiac syndrome, brain connectomics
- Medical subject headings
- Brain Injuries, Traumatic, Neurocirculatory Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TBI-CCS | Patients with TBI-induced CCS, including myocardial injury, arrhythmia or heart failure. | |
| Non TBI-CCS | Patients with non TBI-induced CCS. | |
| Normal control | Normal healthy people. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain network evaluation by MRI
MRI data of all participants are acquired within 3 days after enrollment, and the MRI scans include one or more of the following contents：
- 3D T1-weighted images, which were acquired with a magnetization prepared rapid-acquisition gradient-echo sequence.
- The resting state-fMRI data, acquired with an interleaved T2-weighted axial gradient-echo echoplanar imaging sequence.
- DTI datasets, acquired using a fully-sampled spin-echo EPI sequence.
Measured: Within 3 days after enrollment
Cardiac evaluation by ECG
ECG data of all participants are acquired within 3 days after enrollment, and include resting and ambulatory ECG to detect arrhythmias, heart rate variability or myocardial ischemia. Specifically, arrhythmias include atrial fibrillation (irregular R-R intervals, absent P waves, fibrillatory waves), ventricular tachycardia (QRS >120 ms, rapid rate, often no discernible P waves), heart blocks (1st degree: PR interval >200 ms; 2nd degree: progressive PR prolongation until a QRS drops; 3rd degree: complete AV dissociation and atrial rate > ventricular rate) and premature contractions (early beats with wide or narrow QRS). Heart rate variability is analyzed via R-R interval variability over time (24-hour Holter), and the indicators include Time-Domain (SDNN and RMSSD) and Frequency-Domain (LF/HF ratio). Myocardial ischemia indicators include ST segment depression ≥0.5 mm in ≥2 contiguous leads, ST elevation ≥1 mm in ≥2 contiguous leads, and inversion or hyperacute T waves.
Measured: Within 3 days after enrollment
Cardiac evaluation by echocardiography
Echocardiography data of all participants are acquired within 3 days after enrollment, in order to assess heart pumping function. Specifically, the key parameters assessed include ventricular function (ejection fraction: % of blood ejected per beat) and cardiac output quantification. The decline in the above indicators suggests heart ischemia or heart failure.
Measured: Within 3 days after enrollment
Cardiac evaluation by blood testing-1
Blood testing data of all participants are acquired within 3 days after enrollment and include several key cardiac biomarkers: myoglobin (normal: 14.3-65.8 μg/L), cardiac troponin I (cTnI, normal: 0-0.03 μg/L), cardiac troponin T (cTnT, normal: 0-0.1 μg/L), B-type natriuretic peptide (BNP, normal: 0-0.1 μg/L) and NT-proBNP (normal: <0.3 μg/L). Specifically, elevated myoglobin is useful for early detection of myocardial infarction (MI); elevated cTnI and cTnT, especially with a rising/falling pattern, are gold standard for diagnosing MI; elevated BNP and NT-proBNP suggest heart failure (HF), especially BNP >0.4 μg/L indicates severe HF.
Measured: Within 3 days after enrollment
Cardiac evaluation by blood testing-2
Blood testing data of all participants are acquired within 3 days after enrollment and include the following cardiac biomarkers: creatine kinase (CK, normal: 21-190 U/L ), CK-MB (normal: 0-25 U/L) and lactate dehydrogenase (LDH, normal: 114-240 U/L). Specifically, elevated CK and CK-MB suggest cardiac muscle injury; elevated LDH are useful for early detection of MI.
Measured: Within 3 days after enrollment
Secondary outcomes (2)
Clinical prognosis assessed by GOS score
Glasgow Outcome Scale (GOS) score (1 = death; 2 = persistent vegetative state; 3 = severe disability; 4 = moderate disability; 5 = good but not necessarily complete recovery; unfavorable outcome was defined as score of ≤3, and favorable outcome was defined as a score of >3)
Measured: One month, three and six months after trauma
Neurological function assessed by mRS score
Modified Rankin Scale (mRS) score (0 = no symptoms; 1 = no significant disability; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = dead; favorable outcome was defined as score of 0-2, and unfavorable outcome was defined as score of 3-6)
Measured: One month, three and six months after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start10 Aug 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Chen, MD, PhD, Shanghai 6th People's Hospital
- Investigators
- Hao Chen, M.D., Ph.D., Study director, Shanghai 6th Peoples' HospitalLai Wei, M.D., Principal investigator, Shanghai 6th Peoples' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958406
- Sponsor's protocol ID
- 2024-KY-136（K）
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesion-Network Mapping Analysis With Brain Connectomics to Reveal the Neural Mechanisms of Cerebrocardiac Syndrome Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06958406
- Acronym / sponsor ID
- 2024-KY-136（K）
- Conditions
- Traumatic Brain Injury, Cerebrocardiac Syndrome
- Keywords
- traumatic brain injury, cerebrocardiac syndrome, brain connectomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 May 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.
Cerebrocardiac syndrome (CCS), including myocardial injury, arrhythmia or heart failure is one of serious complications of traumatic brain injury (TBI), mostly occurs within seven days after TBI, which directly aggravates the brain damage and affects the prognosis of TBI patients. Accumulative evidences suggest that autonomic nervous system disorder is a key initiation point for CCS, but how TBI affects the specific action patterns is not yet clear. Therefore, elucidating the neural mechanisms of TBI-induced CCS, maintaining the central sympathetic-parasympathetic balance through novel interventions such as noninvasive brain stimulation, may fundamentally block the downstream peripheral mechanism, thus achieving effective prevention and treatment for CCS. Based on the current emerging research in brain connectomics and lesion-symptom mapping, we speculate that cerebral contusions can cause structural or functional disconnection of key nodes in the central autonomic nervous system regulatory network, thereby mediating the occurrence of TBI-induced CCS.
In this study, magnetic resonance imaging (MRI) or functional MRI (fMRI) examinations were performed in patients with mild or moderate TBI with aim to explore the association between structural and functional disconnection caused by cerebral contusion and TBI-induced CCS, and to screen out the neural anatomical structures to predict CCS following TBI, providing therapy targets for prevention and treatment of CCS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBI-CCS | – | –Patients with TBI-induced CCS, including myocardial injury, arrhythmia or heart failure. |
| Non TBI-CCS | – | –Patients with non TBI-induced CCS. |
| Normal control | – | –Normal healthy people. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Traumatic brain injury patients and healthy volunteers.
Key inclusion criteria (5 listed)
- Patients with isolated closed head trauma
- Age 18-80 years old
- Admitted to hospital within 24 hours of injury
- Mild or moderate TBI (Glasgow Coma Scale score of 9-15)
- Signed consent form
Key exclusion criteria (6 listed)
- Severe TBI (Glasgow Coma Scale score of 3-8)
- A history of stroke, TBI, intracranial tumor or surgery in the past 1 year
- A history of coronary heart disease, structural heart disease and other primary heart diseases or suspected cardiac symptoms prior to injury
- Causes of abnormal cardiac biomarkers such as renal insufficiency, severe anemia, sepsis, cardiotoxic drugs and so on
- Not suitable for MRI examinations, such as pregnant women and those with metal implants in the body
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
Brain network evaluation by MRI
Time frame: Within 3 days after enrollment
MRI data of all participants are acquired within 3 days after enrollment, and the MRI scans include one or more of the following contents： 1. 3D T1-weighted images, which were acquired with a magnetization prepared rapid-acquisition gradient-echo sequence. 2. The resting state-fMRI data, acquired with an interleaved T2-weighted axial gradient-echo echoplanar imaging sequence. 3. DTI datasets, acquired using a fully-sampled spin-echo EPI sequence.
Cardiac evaluation by ECG
Time frame: Within 3 days after enrollment
ECG data of all participants are acquired within 3 days after enrollment, and include resting and ambulatory ECG to detect arrhythmias, heart rate variability or myocardial ischemia. Specifically, arrhythmias include atrial fibrillation (irregular R-R intervals, absent P waves, fibrillatory waves), ventricular tachycardia (QRS >120 ms, rapid rate, often no discernible P waves), heart blocks (1st degree: PR interval >200 ms; 2nd degree: progressive PR prolongation until a QRS drops; 3rd degree: complete AV dissociation and atrial rate > ventricular rate) and premature contractions (early beats with wide or narrow QRS). Heart rate variability is analyzed via R-R interval variability over time (24-hour Holter), and the indicators include Time-Domain (SDNN and RMSSD) and Frequency-Domain (LF/HF ratio). Myocardial ischemia indicators include ST segment depression ≥0.5 mm in ≥2 contiguous leads, ST elevation ≥1 mm in ≥2 contiguous leads, and inversion or hyperacute T waves.
Cardiac evaluation by echocardiography
Time frame: Within 3 days after enrollment
Echocardiography data of all participants are acquired within 3 days after enrollment, in order to assess heart pumping function. Specifically, the key parameters assessed include ventricular function (ejection fraction: % of blood ejected per beat) and cardiac output quantification. The decline in the above indicators suggests heart ischemia or heart failure.
Cardiac evaluation by blood testing-1
Time frame: Within 3 days after enrollment
Blood testing data of all participants are acquired within 3 days after enrollment and include several key cardiac biomarkers: myoglobin (normal: 14.3-65.8 μg/L), cardiac troponin I (cTnI, normal: 0-0.03 μg/L), cardiac troponin T (cTnT, normal: 0-0.1 μg/L), B-type natriuretic peptide (BNP, normal: 0-0.1 μg/L) and NT-proBNP (normal: <0.3 μg/L). Specifically, elevated myoglobin is useful for early detection of myocardial infarction (MI); elevated cTnI and cTnT, especially with a rising/falling pattern, are gold standard for diagnosing MI; elevated BNP and NT-proBNP suggest heart failure (HF), especially BNP >0.4 μg/L indicates severe HF.
Cardiac evaluation by blood testing-2
Time frame: Within 3 days after enrollment
Blood testing data of all participants are acquired within 3 days after enrollment and include the following cardiac biomarkers: creatine kinase (CK, normal: 21-190 U/L ), CK-MB (normal: 0-25 U/L) and lactate dehydrogenase (LDH, normal: 114-240 U/L). Specifically, elevated CK and CK-MB suggest cardiac muscle injury; elevated LDH are useful for early detection of MI.
2 secondary outcomes
Clinical prognosis assessed by GOS score
Time frame: One month, three and six months after trauma
Neurological function assessed by mRS score
Time frame: One month, three and six months after trauma
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 23 Apr 2026.
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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.
Hao Chen, M.D., Ph.D. study director
Shanghai 6th Peoples' Hospital
Lai Wei, M.D. principal investigator
Shanghai 6th Peoples' Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Cerebrocardiac Syndrome, run by Shanghai 6th People's Hospital at 2 sites in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hao Chen, M.D., Ph.D. (8602164369181 ext. 8405, hao.chen@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain network evaluation by MRI (time frame: Within 3 days after enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.