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CompletedNCT06863324TRITONUpdated Nov 4, 2026

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

An interventional study of Radiation induced Lymphocyte Apoptosis diagnostic test in Trigeminal Neuralgia Treated by Radiosurgery, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention

Updated Nov 4, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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". 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.

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.

02

Conditions studied

  • Trigeminal Neuralgia Treated by Radiosurgery

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03

In context

Trigeminal Neuralgia

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

This study's enrollment of 74 is above the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.

Browse Trigeminal Neuralgia studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

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

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    patients with trigeminal neuralgia treated by radiosurgery

    patient with trigeminal neuralgia, treated by radiosurgery

    Diagnostic Test: Radiation induced Lymphocyte Apoptosis diagnostic test

Interventions

  • Diagnostic testRadiation induced Lymphocyte Apoptosis diagnostic 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

06

What researchers measure

Primary outcomes

  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).

    Time frame: 18 months after radiosurgery

Secondary outcomes

  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

    Time frame: 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.

    Time frame: 18 months after radiosurgery

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Study locations

2 sites
  • Chu de Nice
    Nice, Alpes-maritimes 06000, France
  • Centre Hospitalier Princesse Grace
    Monaco, 98000, Monaco
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in Apr 2026, 12 months.

Of 33 non-industry interventional studies with no phase under Trigeminal Neuralgia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 12 months is below that.

Counting every sponsor, half of 33 studies reached it within 27 months; a quarter within 11 and three quarters within 40.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Sep 2027 → Apr 2026 and completion Mar 2028 → Apr 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Mar 3, 2025
First posted
Mar 7, 2025
StartActual
Apr 1, 2025
Primary completionActual
Apr 27, 2026was Sep 2027
CompletionActual
Apr 27, 2026was Mar 2028
Last update
Nov 4, 2026
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.
Status
Recruiting→Completed
changed Nov 4, 2026
Primary completion
Sep 2027→Apr 27, 2026 (actual)
Nov 4, 2026
Study completion
Mar 2028→Apr 27, 2026 (actual)
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Recruiting→Completed
    Primary completion Sep 2027→Apr 27, 2026 (now actual)
    Study completion Mar 2028→Apr 27, 2026 (now actual)
    + 4 other changes: index terms, verification date, site details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06863324
Responsible party
Sponsor
First posted
Mar 7, 2025
Start date
Apr 1, 2025
Primary completion
Apr 27, 2026
Completion
Apr 27, 2026
Last update
Nov 4, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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