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

Recruiting

• Conditions: Brain Injuries

• Registration Number: NCT06571032
• Lead Sponsor: RenJi Hospital

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-08-14
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRS-R scores 6 months after the patient's discharge	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 Outcome Measures

Name	Time	Method
CRS-R scores during hospitalization	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.

Trial Locations

Locations (1)

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China