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Not Yet RecruitingNCT07357025

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

Longitudinal Resting-State fMRI Assessment of Brain Functional Connectivity in Patients With Trigeminal Neuralgia Treated by Gamma Knife Radiosurgery

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
28 (estimated)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
18 Years – 73 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREResting-State Functional MRIParticipants undergo non-invasive resting-state functional magnetic resonance imaging (rs-fMRI) examinations without contrast injection. Imaging sessions are performed before Gamma Knife radiosurgery and at 1 month, 3 months, and 12 months after treatment. These MRI procedures are conducted solely for research purposes and do not modify standard clinical care. The intervention aims to assess longitudinal changes in brain functional connectivity and their association with clinical outcomes.

Timeline

Start date
2026-04-01
Primary completion
2029-04-01
Completion
2029-04-01
First posted
2026-01-21
Last updated
2026-01-21

Source: ClinicalTrials.gov record NCT07357025. Inclusion in this directory is not an endorsement.