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Clinical Trials/NCT06321146
NCT06321146
Not yet recruiting
Not Applicable

Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

RenJi Hospital5 sites in 1 country210 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coma
Sponsor
RenJi Hospital
Enrollment
210
Locations
5
Primary Endpoint
EEG power spectrum
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
April 30, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Coma over 28 days due to closed traumatic brain injury
  • Age above 18 years old
  • Consented by legal representative

Exclusion Criteria

  • Unstable vital signs
  • History of mental disorder or neurodegenerative diseases
  • Uncontrolled epilepsy
  • Unable to record scalp EEG
  • Pregnancy

Outcomes

Primary Outcomes

EEG power spectrum

Time Frame: within 6 months after discharge

Sequential characteristics of spectral features for EEG in terms of frequency content (the 'ABCD' spectral categories)

Secondary Outcomes

  • Coma Recovery Scale-Revised (CRS-R)(within 6 months after discharge)

Study Sites (5)

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