NCT05677243

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
129mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Dec 2021Dec 2036

Study Start

First participant enrolled

December 15, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 15, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

5 years

First QC Date

December 15, 2022

Last Update Submit

February 17, 2025

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal NeuralgiaRadiosurgeryLINACPain reliefHypesthesia

Outcome Measures

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

    24 months

Secondary Outcomes (2)

  • Toxicity of radiosurgery

    1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years

  • Variation of quality of life

    1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients with trigeminal neuralgia treated by radiosurgery on LINAC

You may qualify if:

  • 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

You may not qualify if:

  • Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis)
  • Previous history of radiosurgery procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

RECRUITING

MeSH Terms

Conditions

Trigeminal NeuralgiaHypesthesia

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesSomatosensory DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Cecile ORTHOLAN, MD

CONTACT

00 377 97 98 84 16cecile.ortholan@chpg.mc

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 10, 2023

Study Start

December 15, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2036

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

MO(1)