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ComaEPICNCT06321146

Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

An observational study of Coma and Brain Injuries, Traumatic, run by RenJi Hospital at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coma, Brain Injuries, Traumatic
How many people
210 participants
Where
5 sitesChina
Study dates
1 May 2024to 30 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with traumatic coma above 18 years old

Who may be able to join

  • Coma over 28 days due to closed traumatic brain injury
  • Age above 18 years old
  • Consented by legal representative

Who cannot join

  • Unstable vital signs
  • History of mental disorder or neurodegenerative diseases
  • Uncontrolled epilepsy
  • Unable to record scalp EEG
  • Pregnancy

Trial locations and contacts

5 sites in 1 country.

Junfeng Feng, Dr. contact

13611860825

fengjfmail@163.com

5 sites in 1 country

China5 sites

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Guoyi Gao, Dr.

  • Xiangya Hospital, Central South University

    Changsha, Hunan

    Jinfang Liu, Dr.

  • Anhui No.2 Provincial People's Hospital

    Hefei, Anhui

    Yongming Zhang, Dr.

  • The General Hospital of Eastern Theater Command

    Nanjing, Jiangsu

    Chiyuan Ma, Dr.

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

    Shanghai, Shanghai Municipality, 201114

    Junfeng Feng, +8613611860825, fengjfmail@163.com

Other trials in China

About this study

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.

Read the 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.

Keywords
Coma, Traumatic brain injury, EEG power spectrum
Medical subject headings
Coma, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06321146
Study groupRoleWhat they receive
V-P shunt groupComatose TBI patients who underwent V-P shunt surgery
Cranioplasty groupComatose TBI patients who underwent cranioplasty surgery
SCS groupComatose TBI patients who underwent spinal cord stimulation
RMNS groupComatose TBI patients who underwent right median nerve stimulation
DAI groupComatose TBI patients with diffuse axonal injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG power spectrum

    Sequential characteristics of spectral features for EEG in terms of frequency content (the 'ABCD' spectral categories)

    Measured: within 6 months after discharge

Secondary outcomes (1)

  1. Coma Recovery Scale-Revised (CRS-R)

    Coma Recovery Scale-Revised in patients with traumatic coma

    Measured: within 6 months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06321146
Sponsor's protocol ID
LY2024-029-B
Acronym
EPIC
Status last verified
Mar 2024
First submitted
10 Mar 2024
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary. A Data Access Agreement is required, and all access must comply with regulatory restrictions imposed on the original study.

Publications

  • 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.

    PubMed 33318675

  • 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.

    PubMed 36563999

  • 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.

    PubMed 28168211

  • 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.

    PubMed 32917521

  • 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.

    PubMed 31003899

  • 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.

    PubMed 32241920

  • 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.

    PubMed 35569326

  • 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.

    PubMed 35076993

Questions about this trial

What is this clinical trial studying?

An observational study of Coma and Brain Injuries, Traumatic, run by RenJi Hospital at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Junfeng Feng, Dr. (13611860825, fengjfmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG power spectrum (time frame: within 6 months after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06321146, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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