Resting-State fMRI Study of Functional Connectivity After Gamma Knife Radiosurgery in Trigeminal Neuralgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resting-State Functional MRI.
- Who it may be relevant to
- Registry conditions: Trigeminal Neuralgia. Basic parameters: 18 years — 73 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Longitudinal Resting-State fMRI Assessment of Brain Functional Connectivity in Patients With Trigeminal Neuralgia Treated by Gamma Knife Radiosurgery
Overview
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.
Interventions
- Procedure Resting-State Functional MRI
Participants 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.
Primary outcome measures
- Normalization of resting-state functional connectivity at 3 months [Time frame: 3 months after radiosurgery]
Secondary outcome measures (2)
- Longitudinal changes in resting-state functional connectivity [Time frame: Baseline, 1 month, 3 months, and 12 months after radiosurgery]
- Pain outcome assessed by Barrow Neurological Institute (BNI) Pain Intensity Scale [Time frame: Baseline, 1 month, 3 months, and 12 months after radiosurgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07357025 · RCAPHM25_0106_DOCTRINE