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

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.

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Key information

Conditions

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

Age range

18 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Normalization of resting-state functional connectivity at 3 months

Time frame: 3 months after radiosurgery

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.

Secondary outcomes

Longitudinal changes in resting-state functional connectivity

Time frame: Baseline, 1 month, 3 months, and 12 months after radiosurgery

Percentage of normalization of rs-fMRI connectivity patterns at 1 month, 3 months, and 12 months after Gamma Knife radiosurgery, compared with pre-treatment imaging.
Pain outcome assessed by Barrow Neurological Institute (BNI) Pain Intensity Scale

Time frame: Baseline, 1 month, 3 months, and 12 months after radiosurgery

Change in pain status assessed using the Barrow Neurological Institute Pain Intensity Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Anne BALOSSIER, MD PHD

CONTACT

[email protected]

+334 91 38 65 65

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: DOCTRINE

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jan 21, 2026
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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