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RecruitingNCT05677243NATUREUpdated Feb 19, 2025

Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

An observational study in Trigeminal Neuralgia, sponsored by Centre Hospitalier Princesse Grace. Recruiting at 1 site in Monaco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Centre Hospitalier Princesse Grace · Observational

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia

Read the detailed description

This retrospective and prospective case-series hospital-based study will be conducted in all patients with trigeminal neuralgia treated by radiosurgery on LINAC at the Centre Hospitalier Princesse Grace from april 2018 to january 2028. Patients will be treated with frameless technic and receive 90 Gy delivered with high dose rate on the intra cisternal portion of the trigeminal nerve.

02

Conditions studied

  • Trigeminal Neuralgia

Keywords

  • Trigeminal Neuralgia
  • Radiosurgery
  • LINAC
  • Pain relief
  • Hypesthesia
03

In context

Trigeminal Neuralgia

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

This study's planned enrollment of 150 is above the median of 84 across 38 observational studies indexed under Trigeminal Neuralgia.

Browse Trigeminal Neuralgia studies →

Lead sponsor

Centre Hospitalier Princesse Grace is the lead sponsor of 19 studies on the registry; 4 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
Sampling method
Probability sample

Study population

all patients with trigeminal neuralgia treated by radiosurgery on LINAC

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

  • Classical trigeminal neuralgia according the International Classification of Headache Disorders
  • Trigeminal neuralgia resistant to the maximum tolerated medical therapy, with pain intensity according to the Barrow Neurological Institute (BNI) score IV or V.
  • Patients aged > 18

Exclusion criteria

Exclusion Criteria:

  • Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis)
  • Previous history of radiosurgery procedure
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Pain relief

    Barrow Neurological Institute pain intensity scale - score I to V - V is the worst Barrow Neurological Institute (BNI) pain intensity scale Barrow Neurological Institute (BNI) pain intensity scale

    Time frame: 24 months

Secondary outcomes

  1. Toxicity of radiosurgery

    Common Terminology Criteria for Adverse Events version 5.0 - grade 1 to 5 - 5 is the worst

    Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years

  2. Variation of quality of life

    Short Form 36 Health Survey - score 0 to 100 - 0 is the worst

    Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2021 (actual). Primary completion is estimated for Dec 2026, 60 months after the start.

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

Registered
Dec 15, 2022
First posted
Jan 10, 2023
StartActual
Dec 15, 2021
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2036
Last update
Feb 19, 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 Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05677243
Lead sponsor
Centre Hospitalier Princesse Grace
Responsible party
Sponsor
First posted
Jan 10, 2023
Start date
Dec 15, 2021
Primary completion
Dec 2026 (estimated)
Completion
Dec 2036 (estimated)
Last update
Feb 19, 2025

Study contacts

Cecile ORTHOLAN, MD
Contact
cecile.ortholan@chpg.mc
00 377 97 98 84 16

Oversight

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

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