Observational Study on the Treatment of Trigeminal Neural... | NCT05677243

Studies
Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

NCT05677243

Sponsor

Centre Hospitalier Princesse Grace

Status

Recruiting

Last Update Posted

Feb 19, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Trigeminal Neuralgia

Interventions

Not provided

Countries

Monaco

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2021Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2036Estimated

First Submitted Date

Dec 15, 2022

First Submission Date that Met QC Criteria

Dec 22, 2022

First Posted Date

Jan 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2025

Last Update Posted Date

Feb 19, 2025Actual

Name	Class
Centre Hospitalier Universitaire de Nice	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Toxicity of radiosurgery	Common Terminology Criteria for Adverse Events version 5.0 - grade 1 to 5 - 5 is the worst	1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years
Variation of quality of life	Short Form 36 Health Survey - score 0 to 100 - 0 is the worst

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all patients with trigeminal neuralgia treated by radiosurgery on LINAC

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cecile ORTHOLAN, MD	Contact	00 377 97 98 84 16		cecile.ortholan@chpg.mc

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Princesse Grace	Recruiting	Monaco		98000	Monaco

Condition Browse Module

MeSH Terms

ID	Term
D014277	Trigeminal Neuralgia
D006987	Hypesthesia

Ancestor Terms

ID	Term
D020433	Trigeminal Nerve Diseases
D005156	Facial Neuralgia
D005155	Facial Nerve Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided