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Not Yet RecruitingNCT07238244

Risk Factors for Recurrence of Trigeminal Neuralgia After Percutaneous Balloon Compression

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
700 (estimated)
Sponsor
Second Xiangya Hospital of Central South University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPercutaneous Balloon CompressionThe 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.

Timeline

Start date
2025-12-15
Primary completion
2026-02-15
Completion
2026-03-15
First posted
2025-11-20
Last updated
2025-11-20

Source: ClinicalTrials.gov record NCT07238244. Inclusion in this directory is not an endorsement.