Risk Factors for Recurrence of Trigeminal Neuralgia After Percutaneous Balloon Compression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-03-15

Brief Summary

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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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Detailed Description

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Conditions

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Trigeminal Neuralgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No