Risk Factors for Recurrence of Trigeminal Neuralgia After Percutaneous Balloon Compression

NCT07238244 | Not Yet Recruiting DMC

• 1 other identifier: LYF2022139
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief 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

Trigeminal Neuralgia

Keywords

Trigeminal Neuralgia; Percutaneous Balloon Compression; predication; Machine Learning Model

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead
• Yueyang Hospital of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 20, 2025
• Study Start: December 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP