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NCT Number: NCT05677243

Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

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

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Hypesthesia Mouth Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Princesse Grace

Monaco, 98000

Location status: Recruiting

Location contact

Cecile ORTHOLAN, MD

PRINCIPAL_INVESTIGATOR

Celine DUGOURD

CONTACT

[email protected]

+377 97 98 84 29

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pain relief

    Time frame: 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 outcomes

  1. Toxicity of radiosurgery

    Time frame: 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

  2. Variation of quality of life

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cecile ORTHOLAN, MD

CONTACT

[email protected]

00 377 97 98 84 16

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Princesse Grace

Other

Collaborators

  • Centre Hospitalier Universitaire de Nice

Registry information

Acronym: NATURE

Important dates

Study start
2021
Primary completion
2026
Study completion
2036
First posted
Jan 10, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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