Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

Not yet recruiting

• Conditions: Brain Injuries, Traumatic; Coma

• Registration Number: NCT06321146
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-17
• Last Update Submitted: 2024-03-17
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Study Start: 2024-05-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (5)

Anhui No.2 Provincial People's Hospital; 🇨🇳 Hefei, Anhui, China

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The General Hospital of Eastern Theater Command; 🇨🇳 Nanjing, Jiangsu, China

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China