An observational study in Coma and Brain Injuries, Traumatic, sponsored by RenJi Hospital. Not yet recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by RenJi Hospital · Observational
Development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. We aim to conduct multicenter prospective observational study and non-invasively collect EEG from patients with traumatic coma to analyze the sequential characteristics of EEG power spectrum, and explore their prognostic value for consciousness recovery.
Trauma brain injury is a leading cause of chronic disorders of consciousness (DoC), posing significant socioeconomic burdens due to the extensive resources required for long-term medical care. DoC patients are clinically categorized into coma, Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS), with the latter further subdivided into MCS- and MCS+. The Coma Recovery Scale-Revised (CRS-R) remains a cornerstone for diagnosis and assessment of DoC, despite its susceptibility to fluctuations caused by various factors such as comorbidities and medication. Given these challenges, the development of objective, reliable, and convenient assessment methods of DoC is crucial. Electroencephalography (EEG) stands out for its accessibility and is recommended by guidelines. The mesocircuit model underscores the role of central thalamic neurons and their frontostriatal connections in maintaining consciousness. Based on this mechanism, EEG power spectra were categorized into 4 patterns, i.e. the ABCD model, which can be used to understand the varying levels of structural or functional deafferentation that occur in patients with DoC. Preliminary studies have shown the potential of corticothalamic EEG classification in correlating with CRS-R scores and neurological outcomes, suggesting its value in monitoring treatment effects and predicting prognosis. This multicenter prospective observational study aims to enroll patients with traumatic coma, analyze the sequential characteristics of corticothalamic EEG power spectrum, and explore their prognostic value for consciousness recovery.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's planned enrollment of 210 is above the median of 100 across 58 observational studies indexed under Coma.
Browse Coma studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
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Patients with traumatic coma above 18 years old
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Exclusion Criteria:
Comatose TBI patients who underwent V-P shunt surgery
Comatose TBI patients who underwent cranioplasty surgery
Comatose TBI patients who underwent spinal cord stimulation
Comatose TBI patients who underwent right median nerve stimulation
Comatose TBI patients with diffuse axonal injury
EEG power spectrum
Sequential characteristics of spectral features for EEG in terms of frequency content (the 'ABCD' spectral categories)
Time frame: within 6 months after discharge
Coma Recovery Scale-Revised (CRS-R)
Coma Recovery Scale-Revised in patients with traumatic coma
Time frame: within 6 months after discharge
Plan to share: Yes — Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary. A Data Access Agreement is required, and all access must comply with regulatory restrictions imposed on the original study.
Supporting information: Study protocol
Time frame: After Publication
Access criteria: Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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