Impact of individual radiosensitivity on complications from radiosurgery for trigeminal neuralgia
Impact of Individual Radiosensitivity on Late Toxicities of Radiosurgery in Essential Trigeminal Neuralgia
This study is trying to see how people's sensitivity to radiation affects the complications they experience after having radiosurgery for severe facial pain from trigeminal neuralgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Nice, Alpes-maritimes and 1 other locations) |
| Trial ID | NCT06863324 on ClinicalTrials.gov |
What this trial studies
This study investigates how individual radiosensitivity affects the late complications experienced by patients undergoing radiosurgery for essential trigeminal neuralgia. Trigeminal neuralgia is characterized by severe facial pain, and radiosurgery is a treatment option for patients who do not respond to medication. The study will assess patients who have undergone this treatment over a year ago and will utilize a diagnostic test to evaluate radiation-induced lymphocyte apoptosis. The goal is to better understand the relationship between radiosensitivity and the occurrence of complications following treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been treated for trigeminal neuralgia by radiosurgery more than 12 months ago.
Not a fit: Patients who have undergone other invasive treatments for neuralgia or those with conditions like multiple sclerosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for radiosurgery, minimizing complications and enhancing treatment outcomes.
How similar studies have performed: While the specific approach of assessing individual radiosensitivity is novel, similar studies have explored complications from radiosurgery, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years of age * Patients treated for trigeminal neuralgia by radiosurgery at CHPG more than 12 months ago * Treatment of the nerve with a 4 or 5 mm cone * Patient affiliated to social security * Patient agreement: obtaining the patient's non-opposition (France) or consent (Monaco) Exclusion Criteria: * Patients pre-treated for neuralgia by another invasive method: thermo coagulation, decompression surgery, radiosurgery... * Patients with multiple sclerosis (MS) * Secondary neuralgia * Hypoesthesia pre-existing treatment * Protected persons: persons deprived of their liberty, patients under guardianship or trusteeship
Where this trial is running
Nice, Alpes-maritimes and 1 other locations
- Chu de Nice — Nice, Alpes-maritimes, France (Recruiting)
- Centre Hospitalier Princesse Grace — Monaco, Monaco (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.