Evaluation of EEG Power Spectrum in Patients With Traumatic Coma (EPIC)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Coma; Brain Injuries, Traumatic

Study type: Observational

Funder types: Other

Identifiers

NCT06321146

LY2024-029-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

210 participants in 5 patient groups

V-P shunt group

Description:

Comatose TBI patients who underwent V-P shunt surgery

Cranioplasty group

Description:

Comatose TBI patients who underwent cranioplasty surgery

SCS group

Description:

Comatose TBI patients who underwent spinal cord stimulation

RMNS group

Description:

Comatose TBI patients who underwent right median nerve stimulation

DAI group

Description:

Comatose TBI patients with diffuse axonal injury