Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery (NATURE)

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

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Cecile ORTHOLAN, MD; Phone Number: 00 377 97 98 84 16; Email: cecile.ortholan@chpg.mc

Study Locations

• Monaco
  • Monaco, Monaco, 98000
    • Recruiting
    • Centre Hospitalier Princesse Grace
    • Contact: Celine DUGOURD; Phone Number: +377 97 98 84 29; Email: recherche.clinique@chpg.mc
    • Contact: Cécile ORTHOLAN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

all patients with trigeminal neuralgia treated by radiosurgery on LINAC

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Princesse Grace
• Collaborators: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pain relief; Radiosurgery; Trigeminal Neuralgia; LINAC; Hypesthesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: 21-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No