Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

NCT ID: NCT05677243

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2036-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trigeminal Neuralgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role collaborator

Centre Hospitalier Princesse Grace

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Princesse Grace

Monaco, , Monaco

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Monaco

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cecile ORTHOLAN, MD

Role: CONTACT

00 377 97 98 84 16

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Celine DUGOURD

Role: primary

+377 97 98 84 29

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-19

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Urologic Lymphadenectomy in AMIGO
NCT05132283 RECRUITING NA