Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Recruiting

• Conditions: Trigeminal Neuralgia

• Registration Number: NCT05677243
• Lead Sponsor: Centre Hospitalier Princesse Grace

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.

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-12
• Study Completion: 2036-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco