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

NCT07357025 | Not Yet Recruiting

• 1 other identifier: RCAPHM25_0106_DOCTRINE
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• Normalization of resting-state functional connectivity at 3 months

  Percentage of normalization of resting-state functional MRI (rs-fMRI) connectivity patterns at 3 months after Gamma Knife radiosurgery, compared with pre-treatment imaging and with age- and sex-matched healthy control data.

  3 months after radiosurgery

Secondary Outcomes (2)

• Longitudinal changes in resting-state functional connectivity

  Baseline, 1 month, 3 months, and 12 months after radiosurgery

• Pain outcome assessed by Barrow Neurological Institute (BNI) Pain Intensity Scale

  Baseline, 1 month, 3 months, and 12 months after radiosurgery

Study Arms (1)

Gamma Knife Radiosurgery - Longitudinal Imaging Follow-up

EXPERIMENTAL

Procedure: Resting-State Functional MRI

Interventions

Resting-State Functional MRI PROCEDURE

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.

Gamma Knife Radiosurgery - Longitudinal Imaging Follow-up

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnostic uncertainty or secondary/idiopathic trigeminal neuralgia
• Previous surgical or radiosurgical treatment for trigeminal neuralgia
• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• François CREMIEUX

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

Anne BALOSSIER, MD PHD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share