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NCT05677243 Clinical Trial

Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Trigeminal Neuralgia Clinical Trial

— NATURE  

Official title:
Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05677243
Other study ID # 21-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2021
Est. completion date December 2036

Study information
Verified date December 2022
Source Centre Hospitalier Princesse Grace
Contact Cecile ORTHOLAN, MD
Phone 00 377 97 98 84 16
Email cecile.ortholan@chpg.mc
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 2036
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Monaco Centre Hospitalier Princesse Grace Monaco

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier Princesse Grace Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

Monaco, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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