Trigeminal NeuralgiaNATURENCT05677243
Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery
An observational study of Trigeminal Neuralgia, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- How many people
- 150 participants
- Where
- 1 siteMonaco
- Study dates
- 15 Dec 2021to Dec 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with trigeminal neuralgia treated by radiosurgery on LINAC
Who may be able to join
- 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
Who cannot join
- Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis)
- Previous history of radiosurgery procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Monaco1 site, 1 recruiting
- Recruiting
Centre Hospitalier Princesse Grace
Monaco, 98000
Celine DUGOURD, +377 97 98 84 29, recherche.clinique@chpg.mc
Cecile ORTHOLAN, MD
About this study
This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia
Read the 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.
- Conditions
- Trigeminal Neuralgia
- Keywords
- Trigeminal Neuralgia, Radiosurgery, LINAC, Pain relief, Hypesthesia
- Medical subject headings
- Trigeminal Neuralgia, Hypesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (2)
Toxicity of radiosurgery
Common Terminology Criteria for Adverse Events version 5.0 - grade 1 to 5 - 5 is the worst
Measured: 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
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start15 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677243
- Sponsor's protocol ID
- 21-19
- Acronym
- NATURE
- Status last verified
- Feb 2025
- First submitted
- 15 Dec 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery
- ClinicalTrials.gov ID
- NCT05677243
- Acronym / sponsor ID
- NATURE / 21-19
- Conditions
- Trigeminal Neuralgia
- Keywords
- Trigeminal Neuralgia, Radiosurgery, LINAC, Pain relief, Hypesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with trigeminal neuralgia treated by radiosurgery on LINAC
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis)
- Previous history of radiosurgery procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecile ORTHOLAN, MD (00 377 97 98 84 16, cecile.ortholan@chpg.mc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.