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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: Percutaneous Balloon Compression

• Study Type: Observational
• Enrollment (Estimated): 700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (aged ≥ 18 years) who underwent percutaneous balloon compression (PBC) with primary trigeminal neuralgia (TN) who had their first PBC treatment at the Department of Pain Medicine, the Second Xiangya Hospital of Central South University between January 2018 and June 2025, and were willing to participate in postoperative follow-up were selected as the study subjects

Description

Inclusion Criteria:

1. Aged ≥ 18 years.
2. Meet the diagnostic criteria for primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3).
3. Undergo the first PBC treatment.
4. Have complete preoperative clinical data, imaging data, and intraoperative records.
5. Have at least one postoperative follow-up record available for determining the recurrence status.

Exclusion Criteria:

1. Secondary trigeminal neuralgia (e.g., caused by cerebellopontine angle tumors, multiple sclerosis, etc.).
2. Missing rate of key predictor variables (e.g., balloon shape) or outcome variables > 15%.
3. Postoperative loss to follow-up (defined as no follow-up records available).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Recurrence After Percutaneous Balloon Compression in Patients with Primary Trigeminal Neuralgia	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.	through study completion, an average of 3 year

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Collaborators: Yueyang Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Trigeminal Neuralgia; Machine Learning Model; Percutaneous Balloon Compression; predication
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Trigeminal Neuralgia
• Other Study ID Numbers: LYF2022139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Individual Participant Data (IPD) to be shared in this study will be strictly de-identified (with all personal identifiers such as names, ID numbers, hospital admission numbers, and contact information removed and replaced with unique study serial numbers) and limited to data relevant to verifying the research objectives.Raw imaging files, full electronic medical records, and any sensitive data unrelated to the study's prediction model verification will not be included in the shared IPD to ensure participant privacy and data security.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No