Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
120 participants
OBSERVATIONAL
2021-05-01
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TRACK-TBI Longitudinal Biomarker Study
NCT05201833
Tau And Connectomics In TES Study
NCT05490576
The Value of Combined Detection of Different Blood Biomarkers in the Diagnosis and Treatments of Traumatic Brain Injury
NCT06854835
The DIAGNOSE-CTE Research Project
NCT02798185
Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury
NCT05778123
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Athletes with rmTBI history
50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau
Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
1. Blood tests (30-ml venous blood) for the following items. 1) Transcriptomics and proteomics high-throughput detection and quantitative verification; 2) Exosomal transcriptomics and proteomics high-throughput detection and quantitative verification; 3) Quantitative detection for classical biomarkers of traumatic brain injury, including S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181.
2. Cognitive function tests, including RPQ, MMSE and MoCA.
3. Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
Patients with rmTBI history
50 patients with multiple (≥2 times) exposure to brain trauma attending Tianjin Medical Insurance designated hospitals such as Tianjin Medical University General Hospital
Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
1. Blood tests (30-ml venous blood) for the following items. 1) Transcriptomics and proteomics high-throughput detection and quantitative verification; 2) Exosomal transcriptomics and proteomics high-throughput detection and quantitative verification; 3) Quantitative detection for classical biomarkers of traumatic brain injury, including S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181.
2. Cognitive function tests, including RPQ, MMSE and MoCA.
3. Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
Healthy volunteer
20 healthy volunteers
Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
1. Blood tests (30-ml venous blood) for the following items. 1) Transcriptomics and proteomics high-throughput detection and quantitative verification; 2) Exosomal transcriptomics and proteomics high-throughput detection and quantitative verification; 3) Quantitative detection for classical biomarkers of traumatic brain injury, including S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181.
2. Cognitive function tests, including RPQ, MMSE and MoCA.
3. Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
1. Blood tests (30-ml venous blood) for the following items. 1) Transcriptomics and proteomics high-throughput detection and quantitative verification; 2) Exosomal transcriptomics and proteomics high-throughput detection and quantitative verification; 3) Quantitative detection for classical biomarkers of traumatic brain injury, including S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181.
2. Cognitive function tests, including RPQ, MMSE and MoCA.
3. Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 and ≤ 80 years old with independent behavior ability or authorized legal representative.
* Have a clear history of repetitive mild TBI, concussion or subconcussion.
* The most recent head injury occurred 3 months ago.
2. Healthy Volunteers
* Age ≥ 18 and ≤ 80 years old with independent behavior ability.
* No history of repetitive mild TBI, concussion or subconcussion.
* Fully understands the nature of the study, and voluntarily participates and signs the informed consent.
Exclusion Criteria
* Pregnant or lactating women.
* History of other neurological diseases.
* History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.
* Have participated in clinical trials in the past four weeks.
* The investigator believes that not appropriate for inclusion.
2. Healthy Volunteers
* Pregnant or lactating women.
* History of TBI or other neurological diseases.
* History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.
* Have participated in clinical trials in the past four weeks.
* The investigator believe that not appropriate for inclusion.
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Medical University General Hospital
OTHER
Tianjin Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xintong Ge
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ping Lei, Doctor
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB2021-YX-056-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.