Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery
ConditionTrigeminal Neuralgia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Princesse Grace
About this trial
This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis)
Previous history of radiosurgery procedure
Trial population
all patients with trigeminal neuralgia treated by radiosurgery on LINAC
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
24 monthsSecondary outcomes
1
Toxicity of radiosurgery
Common Terminology Criteria for Adverse Events version 5.0 - grade 1 to 5 - 5 is the worst
Time frame
1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years2
Variation of quality of life
Short Form 36 Health Survey - score 0 to 100 - 0 is the worst
Time frame
1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Princesse Grace
Lead sponsor
Centre Hospitalier Universitaire de Nice
Collaborator
Source ClinicalTrials.gov