Clinical trial NCT06321146: Evaluation of EEG Power Spectrum in Patients With Traumatic Coma
Official title: Evaluation of EEG Power Spectrum in Patients With Traumatic Coma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coma
Brain Injuries, Traumatic
Keywords: Coma
Traumatic brain injury
EEG power spectrum
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Xiangya Hospital of Central South University
name: The General Hospital of Eastern Theater Command
name: Anhui No.2 Provincial People's Hospital
First posted: 2024-03-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with traumatic coma above 18 years old

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.

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

Primary outcomes:
measure: EEG power spectrum
timeFrame: within 6 months after discharge
Secondary outcomes:
measure: Coma Recovery Scale-Revised (CRS-R)
timeFrame: within 6 months after discharge
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui No.2 Provincial People's Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: The General Hospital of Eastern Theater Command
state: Jiangsu
city: Shanghai
country: China
facility: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Junfeng Feng, Dr.
role: STUDY_DIRECTOR
affiliation: Beijing Tiantan Hospital
name: Guoyi Gao, Dr.
role: STUDY_DIRECTOR
affiliation: Xiangya Hospital of Central South University
name: Jinfang Liu, Dr.
role: STUDY_DIRECTOR
affiliation: The General Hospital of Eastern Theater Command
name: Chiyuan Ma, Dr.
role: STUDY_DIRECTOR
affiliation: Anhui No.2 Provincial People's Hospital
name: Yongming Zhang, Dr.
role: STUDY_DIRECTOR
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