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

NCT06571032 | Recruiting

• 1 other identifier: LY2024-007
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Brain Injuries

Keywords

Electroencephalography; Severe traumatic brain injuries

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

• CRS-R scores during hospitalization

  3 months

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients have severe TBI and receive neuroelectral stimulation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 201114, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Junfeng Feng, Ph.D.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiji Weng, Ph.D.

CONTACT

+8613916673435; zigzagweng@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Brain Injury Center

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: August 15, 2024
• Primary Completion: August 14, 2025
• Study Completion: December 31, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

CN (1)