Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05677243

Acronym

NATURE

Enrollment

150

Registered

2023-01-10

Start date

2021-12-15

Completion date

2036-12-31

Last updated

2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal Neuralgia, Radiosurgery, LINAC, Pain relief, Hypesthesia

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
Pain relief	24 months	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

Secondary

Measure	Time frame	Description
Toxicity of radiosurgery	1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years	Common Terminology Criteria for Adverse Events version 5.0 - grade 1 to 5 - 5 is the worst
Variation of quality of life	1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years	Short Form 36 Health Survey - score 0 to 100 - 0 is the worst

Countries

Monaco

Contacts

Primary ContactCecile ORTHOLAN, MD

cecile.ortholan@chpg.mc00 377 97 98 84 16

Outcome results