Clinical trial NCT06958406: Neural Mechanism of Cerebrocardiac Syndrome Following Traumatic Brain Injury
Official title: Lesion-Network Mapping Analysis With Brain Connectomics to Reveal the Neural Mechanisms of Cerebrocardiac Syndrome Following Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Cerebrocardiac Syndrome
Keywords: traumatic brain injury
cerebrocardiac syndrome
brain connectomics
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic brain injury patients and healthy volunteers.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Brain network evaluation by MRI
timeFrame: Within 3 days after enrollment
measure: Cardiac evaluation by ECG
timeFrame: Within 3 days after enrollment
measure: Cardiac evaluation by echocardiography
timeFrame: Within 3 days after enrollment
measure: Cardiac evaluation by blood testing-1
timeFrame: Within 3 days after enrollment
measure: Cardiac evaluation by blood testing-2
timeFrame: Within 3 days after enrollment
Secondary outcomes:
measure: Clinical prognosis assessed by GOS score
timeFrame: One month, three and six months after trauma
measure: Neurological function assessed by mRS score
timeFrame: One month, three and six months after trauma
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th Peoples' Hospital
name: Hao Chen, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Shanghai 6th Peoples' Hospital
name: Lai Wei, M.D.
role: PRINCIPAL_INVESTIGATOR
References: