Trigeminal NeuralgiaNCT07238244
Risk Factors for Recurrence of Trigeminal Neuralgia After Percutaneous Balloon Compression
An observational study of Trigeminal Neuralgia, run by Second Xiangya Hospital of Central South University.
Trial summary
The goal of this observational study is to develop and validate a machine learning-based model for predicting pain recurrence risk after percutaneous balloon compression (PBC) in adult patients with primary trigeminal neuralgia (TN) who had their first PBC treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Percutaneous Balloon Compression
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged ≥ 18 years) who underwent percutaneous balloon compression (PBC) with primary trigeminal neuralgia (TN) who had their first PBC treatment at the Department of Pain Medicine, the Second Xiangya Hospital of Central South University between January 2018 and June 2025, and were willing to participate in postoperative follow-up were selected as the study subjects
Who may be able to join
- Aged ≥ 18 years.
- Meet the diagnostic criteria for primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3).
- Undergo the first PBC treatment.
- Have complete preoperative clinical data, imaging data, and intraoperative records.
- Have at least one postoperative follow-up record available for determining the recurrence status.
Who cannot join
- Secondary trigeminal neuralgia (e.g., caused by cerebellopontine angle tumors, multiple sclerosis, etc.).
- Missing rate of key predictor variables (e.g., balloon shape) or outcome variables > 15%.
- Postoperative loss to follow-up (defined as no follow-up records available).
About this study
Official title: Development and Validation of a Machine Learning-Based Risk Prediction Model for Recurrence After Percutaneous Balloon Compression in Trigeminal Neuralgia Patients: A Retrospective Cohort Study
The goal of this observational study is to develop and validate a machine learning-based model for predicting pain recurrence risk after percutaneous balloon compression (PBC) in adult patients with primary trigeminal neuralgia (TN) who had their first PBC treatment. The main questions it aims to answer are:
Can the machine learning-based model accurately predict pain recurrence after PBC in these primary TN patients? What key factors (like patient baseline traits, imaging parameters, surgical operation data) affect PBC post-operative pain recurrence? Do machine learning algorithms perform better than traditional Cox proportional hazards regression in predicting such recurrence? Participants (with existing PBC treatment records) will have their past data-including clinical info from the hospital's electronic medical record system, imaging data from the image archiving system, surgical data from the surgical anesthesia system, and follow-up data from the outpatient system-collected and analyzed to build and validate the prediction model.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Percutaneous Balloon Compression
- Keywords
- Trigeminal Neuralgia, Percutaneous Balloon Compression, predication, Machine Learning Model
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Balloon CompressionProcedure or surgery
The intervention studied is Percutaneous Balloon Compression (PBC). It is a minimally invasive surgical intervention used for the treatment of primary trigeminal neuralgia (TN), which involves percutaneously inserting a balloon to compress the trigeminal ganglion, aiming to relieve pain in patients with TN who are unresponsive to drug therapy or unable to tolerate drug adverse reactions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Recurrence After Percutaneous Balloon Compression in Patients with Primary Trigeminal Neuralgia
The primary outcome measure focuses on whether pain recurrence occurs in patients with primary TN after their first PBC treatment, defined as a dichotomous variable ("recurred" or "not recurred").
Recurrence Criteria: Postoperative pain intensity, as assessed by the Barrow Neurological Institute Pain Intensity Score, rebounds to Grade IV ("persistent pain controllable with medication") or Grade V ("severe pain uncontrollable with medication"), and this pain status persists for at least 1 week. Additionally, the recurrence must be accompanied by the need to increase the dose of pain medication or undergo reinterventional treatment (e.g., repeated PBC or other surgical procedures) to manage the pain.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yueyang Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, YaPing Wang, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238244
- Sponsor's protocol ID
- LYF2022139
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Individual Participant Data (IPD) to be shared in this study will be strictly de-identified (with all personal identifiers such as names, ID numbers, hospital admission numbers, and contact information removed and replaced with unique study serial numbers) and limited to data relevant to verifying the research objectives.Raw imaging files, full electronic medical records, and any sensitive data unrelated to the study's prediction model verification will not be included in the shared IPD to ensure participant privacy and data security.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Machine Learning-Based Risk Prediction Model for Recurrence After Percutaneous Balloon Compression in Trigeminal Neuralgia Patients: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07238244
- Acronym / sponsor ID
- LYF2022139
- Conditions
- Trigeminal Neuralgia
- Keywords
- Trigeminal Neuralgia, Percutaneous Balloon Compression, predication, Machine Learning Model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Yueyang Hospital of Traditional Chinese Medicine
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to develop and validate a machine learning-based model for predicting pain recurrence risk after percutaneous balloon compression (PBC) in adult patients with primary trigeminal neuralgia (TN) who had their first PBC treatment. The main questions it aims to answer are:
Can the machine learning-based model accurately predict pain recurrence after PBC in these primary TN patients? What key factors (like patient baseline traits, imaging parameters, surgical operation data) affect PBC post-operative pain recurrence? Do machine learning algorithms perform better than traditional Cox proportional hazards regression in predicting such recurrence? Participants (with existing PBC treatment records) will have their past data-including clinical info from the hospital's electronic medical record system, imaging data from the image archiving system, surgical data from the surgical anesthesia system, and follow-up data from the outpatient system-collected and analyzed to build and validate the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged ≥ 18 years) who underwent percutaneous balloon compression (PBC) with primary trigeminal neuralgia (TN) who had their first PBC treatment at the Department of Pain Medicine, the Second Xiangya Hospital of Central South University between January 2018 and June 2025, and were willing to participate in postoperative follow-up were selected as the study subjects
Key inclusion criteria (5 listed)
- Aged ≥ 18 years.
- Meet the diagnostic criteria for primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3).
- Undergo the first PBC treatment.
- Have complete preoperative clinical data, imaging data, and intraoperative records.
- Have at least one postoperative follow-up record available for determining the recurrence status.
Key exclusion criteria (3 listed)
- Secondary trigeminal neuralgia (e.g., caused by cerebellopontine angle tumors, multiple sclerosis, etc.).
- Missing rate of key predictor variables (e.g., balloon shape) or outcome variables > 15%.
- Postoperative loss to follow-up (defined as no follow-up records available).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Balloon CompressionThe intervention studied is Percutaneous Balloon Compression (PBC). It is a minimally invasive surgical intervention used for the treatment of primary trigeminal neuralgia (TN), which involves percutaneously inserting a balloon to compress the trigeminal ganglion, aiming to relieve pain in patients with TN who are unresponsive to drug therapy or unable to tolerate drug adverse reactions. | Procedure or surgery | – |
Primary outcome
Pain Recurrence After Percutaneous Balloon Compression in Patients with Primary Trigeminal Neuralgia
Time frame: through study completion, an average of 3 year
The primary outcome measure focuses on whether pain recurrence occurs in patients with primary TN after their first PBC treatment, defined as a dichotomous variable ("recurred" or "not recurred"). Recurrence Criteria: Postoperative pain intensity, as assessed by the Barrow Neurological Institute Pain Intensity Score, rebounds to Grade IV ("persistent pain controllable with medication") or Grade V ("severe pain uncontrollable with medication"), and this pain status persists for at least 1 week. Additionally, the recurrence must be accompanied by the need to increase the dose of pain medication or undergo reinterventional treatment (e.g., repeated PBC or other surgical procedures) to manage the pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Yes. The Individual Participant Data (IPD) to be shared in this study will be strictly de-identified (with all personal identifiers such as names, ID numbers, hospital admission numbers, and contact information removed and replaced with unique study serial numbers) and limited to data relevant to verifying the research objectives.Raw imaging files, full electronic medical records, and any sensitive data unrelated to the study's prediction model verification will not be included in the shared IPD to ensure participant privacy and data security.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, run by Second Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Recurrence After Percutaneous Balloon Compression in Patients with Primary Trigeminal Neuralgia (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.