Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Trigeminal Neuralgia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Monaco
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Pain relief [Time frame: 24 months]
Secondary outcome measures (2)
- Toxicity of radiosurgery [Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years]
- Variation of quality of life [Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Monaco · 1 center
- Centre Hospitalier Princesse Grace — Monaco
Identifiers
NCT: NCT05677243 · 21-19