Not Yet RecruitingNot Applicable

Resting-State fMRI Study of Functional Connectivity After Gamma Knife Radiosurgery in Trigeminal Neuralgia

28 participantsStarted 2026-04-01

Plain-language summary

Trigeminal neuralgia is a severe chronic pain condition with a major impact on quality of life. Although Gamma Knife radiosurgery is an established treatment for pharmacoresistant trigeminal neuralgia, its mechanisms of action and the temporal dynamics of clinical response remain incompletely understood. This prospective longitudinal study aims to investigate changes in brain functional connectivity using resting-state functional magnetic resonance imaging (rs-fMRI) in patients with classical trigeminal neuralgia treated with Gamma Knife radiosurgery. Participants will undergo rs-fMRI examinations before treatment and at 1 month, 3 months, and 12 months after radiosurgery. Functional connectivity patterns will be analyzed over time and correlated with clinical outcomes, including pain intensity and treatment response. Imaging data will be compared with those from a cohort of age- and sex-matched healthy volunteers. The study does not modify standard clinical care; only additional non-invasive MRI examinations without contrast injection are performed for research purposes.

Who can participate

Age range

18 Years – 73 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 to 73 years * Diagnosis of classical trigeminal neuralgia confirmed by an experienced neurologist * Unilateral facial pain with a normal neurological examination * Pharmacoresistant trigeminal neuralgia, defined as failure of at least two appropriate medical treatments, intolerance to medication, or recurrence despite adequate treatment * Indication for Gamma Knife radiosurgery as part of standard clinical care * Affiliation to a social security or health insurance system * Ability to understand the study information and provide written informed consent Exclusion Criteria: * Diagnostic uncertainty or secondary/idiopathic trigeminal neuralgia * Previous surgical or radiosurgical treatment for trigeminal neuralgia * Participation in another interventional clinical study at the time of inclusion * Individuals belonging to protected populations as defined by applicable regulations (including minors, adults under legal protection, persons deprived of liberty, pregnant or breastfeeding women) * Inability to understand the French language * Contraindication to 3 Tesla MRI, including claustrophobia, presence of pacemaker, defibrillator, metallic prosthesis, or any MRI-incompatible device or foreign body * Residence distance incompatible with the required follow-up schedule

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Normalization of resting-state functional connectivity at 3 months

Timeframe: 3 months after radiosurgery

Trial details

NCT IDNCT07357025

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-01

Contact for this trial

Anne BALOSSIER, MD PHD

+334 91 38 65 65 anne.balossier@ap-hm.fr

View on ClinicalTrials.gov More Trigeminal Neuralgia trials