Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321146
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-10
Brief Title:
Evaluation of EEG Power Spectrum in Patients With Traumatic Coma
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Evaluation of EEG Power Spectrum in Patients With Traumatic Coma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None