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Recruiting NCT06958406

Neural Mechanism of Cerebrocardiac Syndrome Following Traumatic Brain Injury

— Observational Traumatic Brain Injury Cerebrocardiac Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury, Cerebrocardiac Syndrome. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Lesion-Network Mapping Analysis With Brain Connectomics to Reveal the Neural Mechanisms of Cerebrocardiac Syndrome Following Traumatic Brain Injury

Overview

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.

Primary outcome measures

  • Brain network evaluation by MRI [Time frame: Within 3 days after enrollment]
  • Cardiac evaluation by ECG [Time frame: Within 3 days after enrollment]
  • Cardiac evaluation by echocardiography [Time frame: Within 3 days after enrollment]
  • Cardiac evaluation by blood testing-1 [Time frame: Within 3 days after enrollment]
  • Cardiac evaluation by blood testing-2 [Time frame: Within 3 days after enrollment]
Secondary outcome measures (2)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 2 centers
  • Shanghai 6th People's Hospital — Shanghai
  • Shanghai Sixth People's Hospital — Shanghai

Identifiers

NCT: NCT06958406 · 2024-KY-136（K）

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗