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Developing a Clinical Prediction Model for Adverse Outcomes in Percutaneous Trigeminal Ganglion Balloon Compression

Completed
Conditions
Trigeminal Neuralgia (TN)
Registration Number
NCT06998420
Lead Sponsor
Affiliated Hospital of Nantong University
Brief Summary

This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is:

1. What factors are associated with adverse postoperative outcomes?

2. What is the occurrence probability of different types of adverse outcomes? The study will record patients' demographic and clinical characteristics, laboratory test results, and conduct follow-ups at 3, 6, and 12 months postoperatively.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
110
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain recurrence (BNI≥Ⅲ)Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints)

BNI Pain Intensity Scale Score:

I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief

Severe sensory impairment (facial numbness with BNI sensory score ≥ Grade III)3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).

BNI Pain Intensity Scale Score:

I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief

Masticatory dysfunction (bite force reduction ≥50% or subjective weakness)3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Secondary Outcome Measures
NameTimeMethod
Diplopia or hearing loss (rare complications to be recorded)3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Postoperative infection (puncture site/intracranial)3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Psychological status (change in HADS score)3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).

he HADS (Hospital Anxiety and Depression Scale) is a self-assessment questionnaire used to screen for anxiety (HADS-A) and depression (HADS-D) in patients, with each subscale ranging from 0 (no symptoms) to 21 (severe symptoms). A score ≥8 on either subscale suggests clinically significant symptoms.

Key features:

14 items (7 for anxiety, 7 for depression)

Simple \& fast (takes \~5 min)

Designed for non-psychiatric medical settings

Example scoring:

0-7: Normal

8-10: Mild

11-14: Moderate

15-21: Severe

Mild sensory abnormalities (BNI sensory score Grade II)3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).

BNI Pain Intensity Scale Score:

I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief

Trial Locations

Locations (1)

The Affiliated Hospital of Nantong University

🇨🇳

NanTong, Jiangsu, China

The Affiliated Hospital of Nantong University
🇨🇳NanTong, Jiangsu, China

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