Trigeminal NeuralgiaDOCTRINENCT07357025
Resting-State fMRI Study of Functional Connectivity After Gamma Knife Radiosurgery in Trigeminal Neuralgia
A study testing Resting-State Functional MRI in people with Trigeminal Neuralgia, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Resting-State Functional MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Longitudinal Resting-State fMRI Assessment of Brain Functional Connectivity in Patients With Trigeminal Neuralgia Treated by Gamma Knife Radiosurgery
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
- Being tested
- Resting-State Functional MRI
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting-State Functional MRIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Gamma Knife Radiosurgery - Longitudinal Imaging Follow-up | Experimental | Not described Receives: Procedure: Resting-State Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after radiosurgery
Secondary outcomes (2)
Longitudinal changes in resting-state functional connectivity
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.
Measured: Baseline, 1 month, 3 months, and 12 months after radiosurgery
Pain outcome assessed by Barrow Neurological Institute (BNI) Pain Intensity Scale
Change in pain status assessed using the Barrow Neurological Institute Pain Intensity Scale
Measured: Baseline, 1 month, 3 months, and 12 months after radiosurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357025
- Sponsor's protocol ID
- RCAPHM25_0106_DOCTRINE
- Acronym
- DOCTRINE
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Resting-State fMRI Assessment of Brain Functional Connectivity in Patients With Trigeminal Neuralgia Treated by Gamma Knife Radiosurgery
- ClinicalTrials.gov ID
- NCT07357025
- Acronym / sponsor ID
- DOCTRINE / RCAPHM25_0106_DOCTRINE
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gamma Knife Radiosurgery - Longitudinal Imaging Follow-up | Experimental | Procedure: Resting-State Functional MRI |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting-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. | Procedure or surgery | Gamma Knife Radiosurgery - Longitudinal Imaging Follow-up |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François CREMIEUX study director
Assistance Publique Hopitaux De Marseille
Questions about this trial
What is this clinical trial studying?
A study testing Resting-State Functional MRI in people with Trigeminal Neuralgia, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne BALOSSIER, MD PHD (+334 91 38 65 65, anne.balossier@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization of resting-state functional connectivity at 3 months (time frame: 3 months after radiosurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.