NATURE: Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Sponsor

Centre Hospitalier Princesse Grace (Other)

Overall Status

Recruiting

CT.gov ID

NCT05677243

Collaborator

Centre Hospitalier Universitaire de Nice (Other)

150

Enrollment

Location

179.5

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2036

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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