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

Study Timeline

• Study Start: 2022-02-10
• Status Verified: 2025-02
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31

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

Name	Time	Method
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

Name	Time	Method
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