Risk Factors for Recurrence of Trigeminal Neuralgia After Percutaneous Balloon Compression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous Balloon Compression.
- Who it may be relevant to
- Registry conditions: Trigeminal Neuralgia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Procedure Percutaneous Balloon Compression
The intervention studied is Percutaneous Balloon Compression (PBC). It is a minimally invasive surgical intervention used for the treatment of primary trigeminal neuralgia (TN), which involves percutaneously inserting a balloon to compress the trigeminal ganglion, aiming to relieve pain in patients with TN who are unresponsive to drug therapy or unable to tolerate drug adverse reactions.
Primary outcome measures
- Pain Recurrence After Percutaneous Balloon Compression in Patients with Primary Trigeminal Neuralgia [Time frame: through study completion, an average of 3 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07238244 · LYF2022139