Evaluation of EEG Power Spectrum in Patients With Traumatic Coma (EPIC)

March 17, 2024 updated by: RenJi Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Anhui No.2 Provincial People's Hospital
        • Contact:
          • Yongming Zhang, Dr.
    • Beijing
      • Beijing, Beijing, China
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
          • Guoyi Gao, Dr.
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital, Central South University
        • Contact:
          • Jinfang Liu, Dr.
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The General Hospital of Eastern Theater Command
        • Contact:
          • Chiyuan Ma, Dr.
    • Shanghai
      • Shanghai, Shanghai, China, 201114
        • Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with traumatic coma above 18 years old

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
V-P shunt group
Comatose TBI patients who underwent V-P shunt surgery
Cranioplasty group
Comatose TBI patients who underwent cranioplasty surgery
SCS group
Comatose TBI patients who underwent spinal cord stimulation
RMNS group
Comatose TBI patients who underwent right median nerve stimulation
DAI group
Comatose TBI patients with diffuse axonal injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG power spectrum
Time Frame: within 6 months after discharge
Sequential characteristics of spectral features for EEG in terms of frequency content (the 'ABCD' spectral categories)
within 6 months after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale-Revised (CRS-R)
Time Frame: within 6 months after discharge
Coma Recovery Scale-Revised in patients with traumatic coma
within 6 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

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

Investigators

  • Study Director: Junfeng Feng, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University
  • Study Director: Guoyi Gao, Dr., Beijing Tiantan Hospital
  • Study Director: Jinfang Liu, Dr., Xiangya Hospital of Central South University
  • Study Director: Chiyuan Ma, Dr., The General Hospital of Eastern Theater Command
  • Study Director: Yongming Zhang, Dr., Anhui No.2 Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-029-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After Publication

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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