Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

Brain Injuries, Traumatic Clinical Trial

— EPIC  

Official title:

Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06321146
• Other study ID #: LY2024-029-B
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: March 2024
• Source: RenJi Hospital
• Contact: Junfeng Feng, Dr.
• Phone: 13611860825
• Email: fengjfmail[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Coma

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	Anhui No.2 Provincial People's Hospital	Hefei	Anhui
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

Sponsors (5)

Lead Sponsor	Collaborator
RenJi Hospital	Anhui No.2 Provincial People's Hospital, Beijing Tiantan Hospital, The General Hospital of Eastern Theater Command, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (8)

Alkhachroum A, Eliseyev A, Der-Nigoghossian CA, Rubinos C, Kromm JA, Mathews E, Bauerschmidt A, Doyle K, Velasquez A, Egbebike JA, Calderon AR, Roh DJ, Park S, Agarwal S, Connolly ES, Claassen J. EEG to detect early recovery of consciousness in amantadine-treated acute brain injury patients. J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):675-676. doi: 10.1136/jnnp-2019-322645. Epub 2020 Apr 2. No abstract available. — View Citation

Comanducci A, Boly M, Claassen J, De Lucia M, Gibson RM, Juan E, Laureys S, Naccache L, Owen AM, Rosanova M, Rossetti AO, Schnakers C, Sitt JD, Schiff ND, Massimini M. Clinical and advanced neurophysiology in the prognostic and diagnostic evaluation of disorders of consciousness: review of an IFCN-endorsed expert group. Clin Neurophysiol. 2020 Nov;131(11):2736-2765. doi: 10.1016/j.clinph.2020.07.015. Epub 2020 Aug 14. — View Citation

Curley WH, Bodien YG, Zhou DW, Conte MM, Foulkes AS, Giacino JT, Victor JD, Schiff ND, Edlow BL. Electrophysiological correlates of thalamocortical function in acute severe traumatic brain injury. Cortex. 2022 Jul;152:136-152. doi: 10.1016/j.cortex.2022.04.007. Epub 2022 Apr 15. — View Citation

Edlow BL, Claassen J, Schiff ND, Greer DM. Recovery from disorders of consciousness: mechanisms, prognosis and emerging therapies. Nat Rev Neurol. 2021 Mar;17(3):135-156. doi: 10.1038/s41582-020-00428-x. Epub 2020 Dec 14. — View Citation

Forgacs PB, Frey HP, Velazquez A, Thompson S, Brodie D, Moitra V, Rabani L, Park S, Agarwal S, Falo MC, Schiff ND, Claassen J. Dynamic regimes of neocortical activity linked to corticothalamic integrity correlate with outcomes in acute anoxic brain injury after cardiac arrest. Ann Clin Transl Neurol. 2017 Jan 6;4(2):119-129. doi: 10.1002/acn3.385. eCollection 2017 Feb. — View Citation

Frohlich J, Crone JS, Johnson MA, Lutkenhoff ES, Spivak NM, Dell'Italia J, Hipp JF, Shrestha V, Ruiz Tejeda JE, Real C, Vespa PM, Monti MM. Neural oscillations track recovery of consciousness in acute traumatic brain injury patients. Hum Brain Mapp. 2022 Apr 15;43(6):1804-1820. doi: 10.1002/hbm.25725. Epub 2022 Jan 25. — View Citation

Schiff ND. Mesocircuit mechanisms in the diagnosis and treatment of disorders of consciousness. Presse Med. 2022 Dec 20;52(2):104161. doi: 10.1016/j.lpm.2022.104161. Online ahead of print. — View Citation

Thibaut A, Schiff N, Giacino J, Laureys S, Gosseries O. Therapeutic interventions in patients with prolonged disorders of consciousness. Lancet Neurol. 2019 Jun;18(6):600-614. doi: 10.1016/S1474-4422(19)30031-6. Epub 2019 Apr 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG power spectrum	Sequential characteristics of spectral features for EEG in terms of frequency content (the 'ABCD' spectral categories)	within 6 months after discharge
Secondary	Coma Recovery Scale-Revised (CRS-R)	Coma Recovery Scale-Revised in patients with traumatic coma	within 6 months after discharge