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RecruitingNCT06571032Updated Nov 15, 2024

Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries

An observational study in Brain Injuries, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational retrospective study is to evaluate the electroencephalography (EEG)'s poficiency in the treatment of neuroelectric stimulation in patients with severe traumatic brain injuries (TBI).

The main questions it aims to answer are:

  1. Whether EEG of patients with severe TBI will change after they receiving neuroelectrial stimulation? If yes, how does it change?
  2. How can EEG be used to evaluate the condition of patients with severe TBI?
02

Conditions studied

  • Brain Injuries

Keywords

  • Electroencephalography
  • Severe traumatic brain injuries
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients have severe TBI and receive neuroelectral stimulation.

Inclusion criteria

  • 7 days after severe traumatic brain injuries (GCS score 3-8);
  • Over 18 years old, regardless of gender;
  • The patient's legal representative is informed and voluntarily signs the consent form.

Exclusion criteria

Exclusion Criteria:

  • Unstable vital signs;
  • History of mental disorders or neurodegenerative diseases;
  • Uncontrolled epilepsy;
  • Severe arrhythmias or patients with implanted cardiac pacemakers;
  • Various conditions that interfere with scalp EEG collection;
  • Pregnant women.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Consicousness improved group

    After receiving neuroelectrial stimulation, the patients with severe TBI have the consciousness improvement (CRS-R score is higher than before).

  • Consicousness unimproved group

    After receiving neuroelectrial stimulation, the patients with severe TBI have no consciousness improvement (CRS-R score remains the same as before).

06

What researchers measure

Primary outcomes

  1. CRS-R scores 6 months after the patient's discharge

    Using the COMA RECOVERY SCALE-REVISED (CRS-R) to evaluate the condition of the patient 6 months after discharge and the effectiveness of neuroelectrial stimulation. The minimum and maximum values of CRS-R is 0 and 23 and higher scores mean a better outcome.

    Time frame: 6 months

Secondary outcomes

  1. CRS-R scores during hospitalization

    Using the COMA RECOVERY SCALE-REVISED (CRS-R) to evaluate the condition of the patient during hospitalization and the effectiveness of neuroelectrial stimulation. The minimum and maximum values of CRS-R is 0 and 23 and higher scores mean a better outcome.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai 201114, China
    • Junfeng Feng, Ph.D. · Contact · fengjfmail@163.com · +8613611860825
    • Junfeng Feng, Ph.D. · Principal investigator
    • Weiji Weng, Ph.D. · Sub investigator
    • Ru Gong, Ph.D. · Sub investigator
    • Zhenghui He, Ph.D. · Sub investigator
    • Zixuan Ma, Ph.D. · Sub investigator
    • Daiwen Zhang, Ph.D. · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06571032
Lead sponsor
RenJi Hospital
Responsible party
Junfeng Feng (Director of Brain Injury Center, RenJi Hospital) — Principal investigator
First posted
Aug 26, 2024
Start date
Aug 15, 2024
Primary completion
Aug 14, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 15, 2024

Study contacts

Weiji Weng, Ph.D.
Contact
zigzagweng@163.com
+8613916673435
Junfeng Feng, Ph.D.
principal investigator · RenJi Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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