Using EEG to assess neuroelectric stimulation in severe brain injuries
Evaluation of Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries: A Prospective Study
This study is testing if using EEG can help track how well neuroelectric stimulation treatment works for people with severe brain injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06571032 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of electroencephalography (EEG) in monitoring neuroelectric stimulation treatment for patients with severe traumatic brain injuries (TBI). It seeks to determine if EEG readings change following neuroelectric stimulation and how these changes can be used to assess patient conditions. The study will include patients who are at least 7 days post-injury and have a Glasgow Coma Scale score between 3 and 8. Data will be collected retrospectively to analyze the relationship between EEG patterns and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced severe traumatic brain injuries and are at least 7 days post-injury.
Not a fit: Patients with unstable vital signs, history of mental disorders, uncontrolled epilepsy, or other conditions that interfere with EEG collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of severe traumatic brain injuries through improved monitoring and treatment strategies.
How similar studies have performed: While there is ongoing research in the field of EEG and brain injury management, this specific approach appears to be novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Junfeng Feng, Ph.D. — RenJi Hospital
- Study coordinator: Weiji Weng, Ph.D.
- Email: zigzagweng@163.com
- Phone: +8613916673435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.