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

NCT06998420 | Completed

• 1 other identifier: 2024-K098-01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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. 1.What factors are associated with adverse postoperative outcomes?
2. 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.

Conditions

Trigeminal Neuralgia (TN)

Keywords

Trigeminal neuralgia; PCGG; poor prognosis; Clinical Prediction Model

Outcome Measures

Primary Outcomes (3)

• Pain recurrence (BNI≥Ⅲ)

  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

  Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints)

• Severe sensory impairment (facial numbness with BNI sensory score ≥ Grade III)

  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

  3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).

• Masticatory dysfunction (bite force reduction ≥50% or subjective weakness)

  3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).

Secondary Outcomes (4)

• Mild sensory abnormalities (BNI sensory score Grade II)

  3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).

• 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).

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

Patients who underwent PCGG surgery at the Pain Department of Affiliated Hospital of Nantong University between 2022 and 2024 and were willing to participate in postoperative follow-up were selected as the study subjects.

You may qualify if:

• Diagnosed with primary trigeminal neuralgia and underwent PBCG at the Pain Department of Affiliated Hospital of Nantong University
• Age ≥18 years
• Willing to complete postoperative follow-up

You may not qualify if:

• Secondary trigeminal neuralgia (e.g., tumor compression, multiple sclerosis)
• Previous interventional treatments for trigeminal neuralgia
• Incomplete follow-up data
• General anesthesia contraindications or significant dysfunction of major organs (cardiac, pulmonary, hepatic, renal) or severe neurological impairment

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, 211600, China

Location

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: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 31, 2025
• Study Start: February 10, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-02

Locations

CN (1)