ClinicalTrials.gg
CompletedNCT06998420Updated May 31, 2025

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

An observational study in Trigeminal Neuralgia (TN), sponsored by Affiliated Hospital of Nantong University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Affiliated Hospital of Nantong University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
110
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies in Trigeminal Neuralgia with a site in China — 6 open to participants now, 6 under way, none of them phase 3. Trigeminal Neuralgia · China.

Started
2022
the only one that year
Observational
4 of 17
1 open now
Registered
16th of 17
by date
Lead sponsor
1 of 17
Affiliated Hospital of Nantong University

Among the 17 studies in Trigeminal Neuralgia with a site in China, this one is the only one that started in 2022, is one of 4 observational ones, and was the 16th registered.

Trigeminal Neuralgia

140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.

Browse Trigeminal Neuralgia studies →

Open to participants now

6 of the 17 studies in Trigeminal Neuralgia with a site in China are open now. Recruiting first, the newest first:

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All 6 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 27 Trigeminal Neuralgia studies recruiting now, 18 (67%) set no upper age limit and 3 (11%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.
03

Conditions studied

  • Trigeminal Neuralgia (TN)

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Keywords

  • Trigeminal neuralgia
  • PCGG
  • poor prognosis
  • Clinical Prediction Model
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  1. Secondary trigeminal neuralgia (e.g., tumor compression, multiple sclerosis)
  2. Previous interventional treatments for trigeminal neuralgia
  3. Incomplete follow-up data
  4. General anesthesia or significant dysfunction of major organs (cardiac, pulmonary, hepatic, renal) or severe neurological impairment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
110 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  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)

    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

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

  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)

    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

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

07

Study locations

1 site
  • The Affiliated Hospital of Nantong University
    Nantong, Jiangsu 211600, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in Feb 2025, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2025
First posted
May 31, 2025
StartActual
Feb 10, 2022
Primary completionActual
Feb 28, 2025
CompletionActual
Feb 28, 2025
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06998420
Lead sponsor
Affiliated Hospital of Nantong University
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Feb 10, 2022
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
May 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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