Risk Factors for Recurrence of Trigeminal Neuralgia After Percutaneous Balloon Compression

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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Percutaneous Balloon Compression

Procedure

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 outcomes

Pain Recurrence After Percutaneous Balloon Compression in Patients with Primary Trigeminal Neuralgia

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Collaborators

Yueyang Hospital of Traditional Chinese Medicine

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Nov 20, 2025
Registry last updated: Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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