Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Chronic, Traumatic; Encephalopathy, Postcontusional
Conditions
Brief summary
In this study, high-throughput screening and multi-omics (transcriptomics and proteomics) joint analysis technology will be employed to explore potential CTE/TES biomarkers (RNA and protein) in blood and its exosomes. Thereafter, these biomarkers will be combined with the reported TBI biomarkers to create a novel set of CTE/TES molecular diagnostic signatures. The findings may open a new avenue for the clinical diagnosis of the disease and the future research on its therapeutic strategy.
Interventions
DIAGNOSTIC_TESTBlood 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
Sponsors
Tianjin Medical University General Hospital
Tianjin Medical University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Athletes and patients with traumatic brain injury * 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
1. Athletes and patients with traumatic brain injury * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood level of novel protein biomarkers for CTE/TES | Baseline | Novel protein biomarkers for CTE/TES will be screened out by transcriptomics + proteomics high-throughput detection and multi-omics bioinformatics analysis. Their levels will be further verified using ELISA assay. |
| Blood level of novel RNA biomarkers for CTE/TES | Baseline | Novel RNA biomarkers for CTE/TES will be screened out by transcriptomics + proteomics high-throughput detection and multi-omics bioinformatics analysis. Their levels will be further verified using RT-PCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Treg cell count and degree of senescence | 5 years post-enrollment | Percentage of serum regulatory T (Treg) cells relative to the total T cell count; Percentage of senescent Treg cells relative to the total Treg cell count |
| Cognitive function tests - RPQ-3 | 5 years post-enrollment | Rivermead post-concussion symptoms questionnaire - 3 (RPQ-3). Reference Range: 0-12. Higher scores mean a worse outcome. |
| Blood level of classical biomarkers for CTE/TES | Baseline | Blood S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181 level detected by ELISA assay |
| Cognitive function tests - MoCA | 5 years post-enrollment | Montreal cognitive assessment (MoCA). Reference Range: 0-30. Higher scores mean a better outcome. |
| Cognitive function tests - MMSE | 5 years post-enrollment | Description: mini-mental state examination (MMSE). Reference Range: 0-30. Higher scores mean a better outcome. |
| Cognitive function tests - RPQ-16 | 5 years post-enrollment | Rivermead post-concussion symptoms questionnaire - 16 (RPQ-16). Reference Range: 0-64. Higher scores mean a worse outcome. |
| Ultrasound examination of the carotid arteries and lower limb arteries | 5 years post-enrollment | Ultrasound examination of bilateral CCA, ICA, CFA, SFA, PA, DPA and ATA |
Countries
China
Outcome results
None listed