--- title: Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury nct_id: NCT05484921 overall_status: UNKNOWN sponsor: Affiliated Hospital of Nantong University study_type: OBSERVATIONAL primary_condition: TBI (Traumatic Brain Injury) countries: China canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05484921.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05484921" ct_last_update_post_date: 2022-08-05 last_seen_at: "2026-05-12T07:26:53.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury **Official Title:** The Specificity and Sensitivity of circMETTL9 Gene in Patients With Traumatic Brain Injury, Its Correlation With Cognitive Function and Disturbance of Consciousness, and Prognosis **NCT ID:** [NCT05484921](https://clinicaltrials.gov/study/NCT05484921) ## Key Facts - **Status:** UNKNOWN - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 150 - **Lead Sponsor:** Affiliated Hospital of Nantong University - **Conditions:** TBI (Traumatic Brain Injury) - **Start Date:** 2022-08-04 - **Completion Date:** 2023-12-30 - **CT.gov Last Update:** 2022-08-05 ## Brief Summary Objective: The relevance of circMETTL9 to the degree of injury, disturbance of consciousness, cognitive function and prognosis in patients with moderate to severe traumatic brain injury (TBI) remains unknown. The purpose of this study was to investigate the effect of circMETTL9 on the degree of injury, disturbance of consciousness, cognitive function and prognosis after TBI. ## Detailed Description 1. Collect blood samples from patients with moderate to severe TBI and healthy people, and detect the expression of circMETTL9 by Real-time Quantitative PCR Detecting System(qPCR).Receiver operating characteristic curve (ROC) was used to analyze the sensitivity and specificity of circMETTL9 in TBI patients. 2. Using the Glasgow coma scale (GCS) and the coma recovery scale-revised (CRS-R) to assess the patient's disturbance of consciousness at 1, 3, 7, 14, and 21 days after TBI, respectively, The cognitive function of patients was assessed with the revised Rachel los amigos scale-revised (RLAS-R), and the correlation of circMETTL9 with disturbance of consciousness and cognitive function in TBI patients was analyzed. 3. Six months after TBI, the disability rating scale (DRS) and Glasgow outcome scale-extended (GOSE) were used to evaluate the prognosis of patients six months after discharge, and the correlation between circMETTL9 and prognosis was analyzed. sex. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: 1. Age from 18 to 80 years old, gender is not limited; 2. Have a clear history of TBI and be diagnosed by head CT, and it is the first episode; 3. Glasgow Coma Scale (GCS) score less than or equal to 12; 4. The condition is relatively stable, and there is no serious chronic disease; 5. Obtain informed consent from patients and (or) their families. Exclusion Criteria: 1 Combined with severe underlying diseases such as respiratory failure, heart failure, liver and kidney insufficiency; previous stroke, intracranial tumor, intracranial infection, dementia, Alzheimer's disease, Parkinson's disease, endocrine disease, immune and blood system diseases. 2\. Patients with pelvic fractures, substantial organ damage, etc., which may seriously affect the treatment effect at the time of injury; ``` ## Arms - **traumatic brain injury group** — (1) age 18-80 years, (2) admission due to isolated head injury, (3) unconsciousness at the time of injury. Isolated head trauma was defined as CT scan-confirmed brain injury without other major extracranial injuries, such as pelvis fractures, femur fractures, and severe invasive abdominal or thoracic injuries. Other exclusion criteria for patients were infection within the most recent month, previous head trauma, neurological diseases including ischemic and hemorrhagic stroke, use of antiplatelet or anticoagulant medications, and other prior systemic diseases including uremia, liver cirrhosis, malignancy, chronic heart disease, and chronic lung disease. ## Primary Outcomes - **The sensitivity and specificity of circMETTL9 in TBI patients were analyzed.** _(time frame: 2022-01-2023-12)_ — rComparison of serum cirMETTL9 expression levels among the three groups. The results of qRT-PCR showed that, compared with the healthy control group, the serum cirMETTL9 expression levels in the moderate TBI group and the severe TBI group were significantly increased, and the serum cirMETTL9 expression level in the severe TBI group was significantly higher than that in the patients with severe TBI. In the moderate TBI group, the difference was statistically significant (P \< 0.05). ## Secondary Outcomes - **The correlation of circMETTL9 in blood samples of TBI patients with disturbance of consciousness and cognitive function in TBI patients was analyzed.** _(time frame: 2022-01-2023-12)_ ## Locations (1) - Affiliated Hospital of Nantong University, Nantong, Jiangsu, China — _RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.affiliated hospital of nantong university|nantong|jiangsu|china` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05484921.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05484921* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*