Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

NCT ID: NCT06321146

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coma Brain Injuries, Traumatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

V-P shunt group

Comatose TBI patients who underwent V-P shunt surgery

No interventions assigned to this group

Cranioplasty group

Comatose TBI patients who underwent cranioplasty surgery

No interventions assigned to this group

SCS group

Comatose TBI patients who underwent spinal cord stimulation

No interventions assigned to this group

RMNS group

Comatose TBI patients who underwent right median nerve stimulation

No interventions assigned to this group

DAI group

Comatose TBI patients with diffuse axonal injury

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

The General Hospital of Eastern Theater Command

OTHER

Sponsor Role collaborator

Anhui No.2 Provincial People's Hospital

UNKNOWN

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Junfeng Feng, Dr.

Role: STUDY_DIRECTOR

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Guoyi Gao, Dr.

Role: STUDY_DIRECTOR

Beijing Tiantan Hospital

Jinfang Liu, Dr.

Role: STUDY_DIRECTOR

Xiangya Hospital of Central South University

Chiyuan Ma, Dr.

Role: STUDY_DIRECTOR

The General Hospital of Eastern Theater Command

Yongming Zhang, Dr.

Role: STUDY_DIRECTOR

Anhui No.2 Provincial People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anhui No.2 Provincial People's Hospital

Hefei, Anhui, China

Site Status

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status

The General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Site Status

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Junfeng Feng, Dr.

Role: CONTACT

13611860825

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yongming Zhang, Dr.

Role: primary

Guoyi Gao, Dr.

Role: primary

Jinfang Liu, Dr.

Role: primary

Chiyuan Ma, Dr.

Role: primary

Junfeng Feng

Role: primary

+8613611860825

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33318675 (View on PubMed)

Schiff ND. Mesocircuit mechanisms in the diagnosis and treatment of disorders of consciousness. Presse Med. 2023 Jun;52(2):104161. doi: 10.1016/j.lpm.2022.104161. Epub 2022 Dec 20.

Reference Type BACKGROUND
PMID: 36563999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28168211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32917521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31003899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32241920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35569326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35076993 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LY2024-029-B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.