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Trigeminal Neuralgia Treated by RadiosurgeryTRITONNCT06863324

Impact of Individual Radiosensitivity on Late Toxicities of Radiosurgery in Essential Trigeminal Neuralgia

A study testing Radiation induced Lymphocyte Apoptosis diagnostic test in people with Trigeminal Neuralgia Treated by Radiosurgery, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Trigeminal neuralgia is intense, electric-shock-like facial pain, most often triggered by touch, chewing or speech. It results from dysfunction of the trigeminal nerve, the 5th cranial nerve. In most cases, no cause is found, and trigeminal neuralgia is termed "essential". Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiation induced Lymphocyte Apoptosis diagnostic test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
2 sitesin 2 countries
Study dates
1 Apr 2025to 27 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Patients ≥ 18 years of age
  • Patients treated for trigeminal neuralgia by radiosurgery at CHPG more than 12 months ago
  • Treatment of the nerve with a 4 or 5 mm cone
  • Patient affiliated to social security
  • Patient agreement: obtaining the patient's non-opposition (France) or consent (Monaco)

Who cannot join

  • Patients pre-treated for neuralgia by another invasive method: thermo coagulation, decompression surgery, radiosurgery...
  • Patients with multiple sclerosis (MS)
  • Secondary neuralgia
  • Hypoesthesia pre-existing treatment
  • Protected persons: persons deprived of their liberty, patients under guardianship or trusteeship

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

France1 site
  • Chu de Nice

    Nice, Alpes-maritimes, 06000

Other trials in France

Monaco1 site
  • Centre Hospitalier Princesse Grace

    Monaco, 98000

Other trials in Monaco

About this study

Trigeminal neuralgia is intense, electric-shock-like facial pain, most often triggered by touch, chewing or speech. It results from dysfunction of the trigeminal nerve, the 5th cranial nerve. In most cases, no cause is found, and trigeminal neuralgia is termed "essential". In the first instance, treatment is based on medication. In cases of drug resistance, radiosurgery is a possible treatment option. This involves performing neurolysis, delivering a very high dose of ionizing radiation to the trigeminal nerve. The immediate success rate of radiosurgery is 80-90%.

However, in the long term, around 30% of patients experience complications (mainly hypoesthesia of the face on the treated side, paresthesias, masticatory disorders, neuropathic pain) and 30% of patients experience a recurrence of neuralgic pain. Most of these complications are permanent, and there are very few effective treatments, either medical or physical. Recurrence and complications are correlated, i.e. patients with hypoesthesia have a lower risk of recurrence. Certain technical parameters are associated with the efficacy and toxicity of radiosurgery, notably the position of the point of impact of the rays on the nerve. However, for identical treatment techniques, there are currently no known prognostic criteria for the efficacy and toxicity of radiosurgery.

Read more

Numerous radiobiological studies have demonstrated that sensitivity to ionizing radiation differs from one individual to another, with each person having his or her own tolerance threshold. Indeed, 5-10% of patients are hypersensitive to ionizing radiation and are at very high risk of developing late complications [Bentzen et al. 2010]. There are currently commercial tests for individual radiosensitivity, based on a simple blood test, whose clinical value has been demonstrated in predicting complications in patients irradiated for breast or prostate cancer. These tests are based on the rate of radiation-induced lymphocyte apoptosis, known as the RILA (Radiation Induced Lymphocyte Apoptosis) score. Numerous teams have shown retrospectively and then prospectively that a high RILA score is significantly correlated with the absence of the development of radiation-induced late adverse events, with a negative predictive value of over 90% (level of evidence 1) [Azria et al. 2015; Mirjolet et al. 2016; Talbot et al. 2019]. In practical terms, the test gives a lymphocyte apoptosis score for each patient. A cut-off point is set below which the patient is considered "radiation hypersensitive".

In this study, the investigators propose to correlate the RILA score with the occurrence of severe late toxicity in patients treated by radiosurgery for trigeminal neuralgia.

In the event of a positive result, this would make it possible either to adapt the radiosurgery technique to minimize the risk of late complications, or to contraindicate radiosurgery and refer patients to other treatment methods.

Being tested
Radiation induced Lymphocyte Apoptosis diagnostic test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation induced Lymphocyte Apoptosis diagnostic testDiagnostic test

    Diagnostic test for estimation of individual radiosensitivity, based on blood test, whose clinical value has been demonstrated in predicting complications in patients irradiated for breast or prostate cancer. These tests are based on the rate of radiation-induced lymphocyte apoptosis, known as the RILA (Radiation Induced Lymphocyte Apoptosis) score

Study groups in NCT06863324
Study groupRoleWhat they receive
patients with trigeminal neuralgia treated by radiosurgeryExperimentalpatient with trigeminal neuralgia, treated by radiosurgery
Receives: Diagnostic Test: Radiation induced Lymphocyte Apoptosis diagnostic test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlate RILA score to the occurrence of severe hypoesthesia following radiosurgery for treatment of trigeminal neuralgia.

    Evaluation of the probability of occurrence of severe late toxicity, i.e. hypoesthesia grade BNI III or IV after 18 months, in patients with low-risk RILA score (score between 21 and 100% lymphocyte apoptosis) vs. high-risk RILA score (score between 0 and 20% lymphocyte apoptosis).

    Measured: 18 months after radiosurgery

Secondary outcomes (2)
  1. Correlate RILA score with radiosurgery efficacy

    Evaluation of the probability of radiosurgery failure (treatment failure or neuralgia recurrence) in patients with low-risk RILA score vs. high-risk RILA score

    Measured: 18 months after radiosurgery

  2. Correlate RILA score to trigeminal nerve hypersignal on postradiosurgery MRI

    Correlation between RILA score and presence of trigeminal nerve hypersignal on MRI performed 6 months after radiosurgery.

    Measured: 18 months after radiosurgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion27 Apr 2026
  4. Study completion27 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06863324
Sponsor's protocol ID
24-01
Acronym
TRITON
Status last verified
Nov 2026
First submitted
3 Mar 2025
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiation induced Lymphocyte Apoptosis diagnostic test in people with Trigeminal Neuralgia Treated by Radiosurgery, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.

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 5 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Correlate RILA score to the occurrence of severe hypoesthesia following radiosurgery for treatment of trigeminal neuralgia. (time frame: 18 months after radiosurgery). 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 4 Nov 2026.

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