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NCT Number: NCT06571032

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

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?

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Key information

Conditions

Brain Injuries Brain Diseases Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 201114, China

Location status: Recruiting

Location contact

Daiwen Zhang, Ph.D.

SUB_INVESTIGATOR

Junfeng Feng, Ph.D.

CONTACT

[email protected]

+8613611860825

Junfeng Feng, Ph.D.

PRINCIPAL_INVESTIGATOR

Ru Gong, Ph.D.

SUB_INVESTIGATOR

Weiji Weng, Ph.D.

SUB_INVESTIGATOR

Zhenghui He, Ph.D.

SUB_INVESTIGATOR

Zixuan Ma, Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

    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.

Secondary outcomes

  1. CRS-R scores during hospitalization

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Weiji Weng, Ph.D.

CONTACT

[email protected]

+8613916673435

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Evaluation of Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries: A Prospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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