Development and Validation of a Machine Learning-Based Risk Prediction Model for Recurrence After Percutaneous Balloon Compression in Trigeminal Neuralgia Patients: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 主要终点
- Pain Recurrence After Percutaneous Balloon Compression in Patients with Primary Trigeminal Neuralgia
研究概览
简要总结
The goal of this observational study is to develop and validate a machine learning-based model for predicting pain recurrence risk after percutaneous balloon compression (PBC) in adult patients with primary trigeminal neuralgia (TN) who had their first PBC treatment. The main questions it aims to answer are:
Can the machine learning-based model accurately predict pain recurrence after PBC in these primary TN patients? What key factors (like patient baseline traits, imaging parameters, surgical operation data) affect PBC post-operative pain recurrence? Do machine learning algorithms perform better than traditional Cox proportional hazards regression in predicting such recurrence? Participants (with existing PBC treatment records) will have their past data-including clinical info from the hospital's electronic medical record system, imaging data from the image archiving system, surgical data from the surgical anesthesia system, and follow-up data from the outpatient system-collected and analyzed to build and validate the prediction model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years.
- •Meet the diagnostic criteria for primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3).
- •Undergo the first PBC treatment.
- •Have complete preoperative clinical data, imaging data, and intraoperative records.
- •Have at least one postoperative follow-up record available for determining the recurrence status.
排除标准
- •Secondary trigeminal neuralgia (e.g., caused by cerebellopontine angle tumors, multiple sclerosis, etc.).
- •Missing rate of key predictor variables (e.g., balloon shape) or outcome variables > 15%.
- •Postoperative loss to follow-up (defined as no follow-up records available).
结局指标
主要结局
Pain Recurrence After Percutaneous Balloon Compression in Patients with Primary Trigeminal Neuralgia
时间窗: through study completion, an average of 3 year
The primary outcome measure focuses on whether pain recurrence occurs in patients with primary TN after their first PBC treatment, defined as a dichotomous variable ("recurred" or "not recurred"). Recurrence Criteria: Postoperative pain intensity, as assessed by the Barrow Neurological Institute Pain Intensity Score, rebounds to Grade IV ("persistent pain controllable with medication") or Grade V ("severe pain uncontrollable with medication"), and this pain status persists for at least 1 week. Additionally, the recurrence must be accompanied by the need to increase the dose of pain medication or undergo reinterventional treatment (e.g., repeated PBC or other surgical procedures) to manage the pain.
次要结局
未报告次要终点
研究者
YaPing Wang
Professor
Second Xiangya Hospital of Central South University