Brain InjuriesNCT06571032
Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries
An observational study of Brain Injuries, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients have severe TBI and receive neuroelectral stimulation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201114
Junfeng Feng, Ph.D., +8613611860825, fengjfmail@163.com
Junfeng Feng, Ph.D.
About this study
Official title: Evaluation of Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries: A Prospective Study
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:
- Whether EEG of patients with severe TBI will change after they receiving neuroelectrial stimulation? If yes, how does it change?
- How can EEG be used to evaluate the condition of patients with severe TBI?
- Conditions
- Brain Injuries
- Keywords
- Electroencephalography, Severe traumatic brain injuries
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
CRS-R scores during hospitalization
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start15 Aug 2024
- Primary completion14 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junfeng Feng, RenJi Hospital
- Investigators
- Junfeng Feng, Ph.D., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571032
- Sponsor's protocol ID
- LY2024-007
- Status last verified
- Nov 2024
- First submitted
- 22 Aug 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries: A Prospective Study
- ClinicalTrials.gov ID
- NCT06571032
- Acronym / sponsor ID
- LY2024-007
- Conditions
- Brain Injuries
- Keywords
- Electroencephalography, Severe traumatic brain injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 14 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether EEG of patients with severe TBI will change after they receiving neuroelectrial stimulation? If yes, how does it change?
- How can EEG be used to evaluate the condition of patients with severe TBI?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have severe TBI and receive neuroelectral stimulation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
CRS-R scores during hospitalization
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junfeng Feng, Ph.D. principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiji Weng, Ph.D. (+8613916673435, zigzagweng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRS-R scores 6 months after the patient's discharge (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.