Neural Mechanism of Cerebrocardiac Syndrome Following Traumatic Brain Injury

NCT ID: NCT06958406

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-06

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury Cerebrocardiac Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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TBI-CCS

Patients with TBI-induced CCS, including myocardial injury, arrhythmia or heart failure.

No interventions assigned to this group

Non TBI-CCS

Patients with non TBI-induced CCS.

No interventions assigned to this group

Normal control

Normal healthy people.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hao Chen, MD, PhD

Associate Professor, Chief Physician, Graduate Supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hao Chen, M.D., Ph.D.

Role: STUDY_DIRECTOR

Shanghai 6th Peoples' Hospital

Lai Wei, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th Peoples' Hospital

Locations

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Shanghai 6th People's Hospital

Shanghai, , China

Site Status RECRUITING

Shanghai Sixth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Chen, M.D., Ph.D.

Role: CONTACT

8602164369181 ext. 8405

Lai Wei, M.D.

Role: CONTACT

8602164369181 ext. 8405

Facility Contacts

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Hao Chen, M.D., Ph.D.

Role: primary

8602164369181 ext. 8405

Other Identifiers

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2024-KY-136(K)

Identifier Type: -

Identifier Source: org_study_id

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