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NCT Number: NCT06998420

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

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.

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Key information

Conditions

Trigeminal Neuralgia (TN) Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases Trigeminal Neuralgia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, 211600, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Pain recurrence (BNI≥Ⅲ)

    Time frame: 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

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

    Time frame: 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

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

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

Secondary outcomes

  1. Mild sensory abnormalities (BNI sensory score Grade II)

    Time frame: 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

  2. Diplopia or hearing loss (rare complications to be recorded)

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

  3. Postoperative infection (puncture site/intracranial)

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

  4. Psychological status (change in HADS score)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

Construction of a Clinical Prediction Model for Poor Prognosis Following Percutaneous Balloon Compression of the Trigeminal Ganglion

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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