Actively Recruiting
Evaluation of Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries: A Prospective Study
Led by RenJi Hospital · Updated on 2024-11-15
50
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how electroencephalography (EEG) can be used in managing neuroelectric stimulation treatment for patients with severe traumatic brain injuries (TBI). This observational retrospective study focuses on whether EEG changes after neuroelectric stimulation and how these changes relate to patient conditions. The study aims to improve understanding of EEG's role in assessing recovery in severe TBI cases. Participants in this study have severe TBI and receive neuroelectric stimulation. The study groups include patients whose consciousness improves after stimulation and those whose consciousness does not improve, as measured by the CRS-R score. The researchers compare EEG results before and after the treatment to assess changes related to patient recovery. Participants will be monitored during hospitalization and followed for six months after discharge. The main outcome is the CRS-R score measured six months post-discharge, with additional assessments during the three-month hospital stay. The study collects EEG data to evaluate brain activity and changes over time, helping to determine the effectiveness of neuroelectric stimulation in severe TBI patients.
CONDITIONS
Brief Title
Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 7 days after severe traumatic brain injury with a Glasgow Coma Scale score between 3 and 8
- 18 years of age or older
- Legal representative has been informed and voluntarily signed the consent form
You will not qualify if you...
- Unstable vital signs
- History of mental disorders or neurodegenerative diseases
- Uncontrolled epilepsy
- Severe arrhythmias or presence of implanted cardiac pacemakers
- Conditions interfering with scalp EEG collection
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months during hospitalization
Participants are observed while receiving neuroelectric stimulation and their consciousness levels are monitored.
Regular assessments during hospitalization
Duration - 6 months after discharge
Participants are followed up to assess consciousness recovery 6 months after discharge.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 201114
Actively Recruiting
Research Team
W
Weiji Weng, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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