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Not Yet RecruitingNCT06321146

Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
210 (estimated)
Sponsor
RenJi Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2024-05-01
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2024-03-20
Last updated
2024-03-20

Locations

5 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06321146. Inclusion in this directory is not an endorsement.

Evaluation of EEG Power Spectrum in Patients With Traumatic Coma (NCT06321146) · Clinical Trials Directory