Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06321146

Acronym

EPIC

Enrollment

210

Registered

2024-03-20

Start date

2024-05-01

Completion date

2026-04-30

Last updated

2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic, Coma

Keywords

Coma, Traumatic brain injury, EEG power spectrum

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
EEG power spectrum	within 6 months after discharge	Sequential characteristics of spectral features for EEG in terms of frequency content (the 'ABCD' spectral categories)

Secondary

Measure	Time frame	Description
Coma Recovery Scale-Revised (CRS-R)	within 6 months after discharge	Coma Recovery Scale-Revised in patients with traumatic coma

Countries

China

Contacts

Primary ContactJunfeng Feng, Dr.

fengjfmail@163.com13611860825

Outcome results