Trigeminal NeuralgiaSENSENCT05051072
Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in "Resting State"
A study testing Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia in people with Trigeminal Neuralgia and Microvascular Decompression Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Essential trigeminal neuralgia is the most common facial pain. In forms resistant to drug and disabling treatments, surgical treatment may be offered to the patient. The type of intervention will be conditioned by the presence or absence of a vasculo-nervous conflict objectified by MRI(Magnetic resonance imaging)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia, Microvascular Decompression Surgery, Diffusion Tensor Imaging
- What is being tested?
- Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2022to Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years and over);
- Supported in the neurosurgery department or at the assessment and treatment center for pain for unilateral essential trigeminal neuralgia with search for vasculo-nervous conflict;
Who cannot join
- Patient with neurodegenerative or inflammatory neurological pathology;
- Patient who has already been operated on for a DMV;
- Absolute contraindication to MRI
- Patient benefiting from a legal protection measure; with impaired judgment skills or unable to receive information;
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation Ophtalmologique de Rothschild
Paris, 75019
Caroline Le Guerinel, +33148036911, cleguerinel@for.paris
About this study
Essential trigeminal neuralgia is the most common facial pain. In forms resistant to drug and disabling treatments, surgical treatment may be offered to the patient. The type of intervention will be conditioned by the presence or absence of a vasculo-nervous conflict objectified by MRI(Magnetic resonance imaging) Morphological MRI with contrast injection does not always allow an accurate assessment of trigeminal nerve damage in patients with essential facial neuralgia. Despite advances in the anatomical definition of high-resolution MRI, the correlation between a vascular conflict visible on MRI and present during surgery and prolonged postoperative clinical improvement remains insufficient These data raise the question of additional imaging sequences to assess the distressing characteristics of NT in addition to the usual anatomical criteria for compression By performing during morphological MRI two additional sequences, one in diffusion tensor (DTI) and one in resting state (fMRI), we could better characterize the achievement of NT
The contribution of new imaging sequences in the context of essential trigeminal neuralgia treated with microvascular decompression (MVD) would:
Read more
1/improve the diagnostic criteria for suffering and compression of the NT (trigeminal nerve) 2 / define objective prognostic criteria for the effectiveness of surgery, particularly in the context of unusual clinical symptoms or moderate conflict on MRI (Magnetic resonance imaging) 3 / to analyze more precisely the causes of recurrence at a distance from surgery and help in the decision of re-intervention Our main hypothesis: the addition of a diffusion tensor sequence and sequences (allowing functional brain analysis) in addition to standard anatomical MRI in the assessment of a vasculo-nervous conflict would allow us to better characterize involvement of the trigeminal nerve in essential facial neuralgia. It also helps guide therapeutic management and surgical indications.
This is a prospective, monocentric cohort study. It will be offered to patients referred to neurosurgery or to the pain assessment and treatment center for assessment and management of a neuralgia of the essential trijumeau unilateral.
Read the detailed description
Name:
MRI in morphological sequence, diffusion tensor and resting functional
Description:
The MR exam will be performed on the Neuroradiology 3 Tesla (Philips) MR according to the following protocol:
- Standard anatomical sequences T1, FLAIR, TOF, DRIVE, sequence centered on the V after injection of gadolinated contrast product as part of standard care
- Diffusion tensor sequence (DTI) It allows the analysis of encephalic white matter beams in healthy subjects as well as in many pathologies
- resting state sequence (fMRI) This sequence is based on the spontaneous correlation of the BOLD signal (blood-oxygen level dependent) between different distant brain regions.
- The total duration of the exam will be about 45 minutes, including 15 minutes for the sequences added by the search.
- Being tested
- Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia
- Keywords
- Resting state
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgiaProcedure or surgery
Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia
| Study group | Role | What they receive |
|---|---|---|
| MRI in morphological sequence, diffusion tensor and resting functional | Other | * standard anatomical sequences T1, FLAIR (Fluid Attenuated Inversion Recovery), TOF(Time-of-flight MR angiography) , DRIVE, sequence centered on the V after injection of gadolinated contrast product as part of routine care,
* diffusion tensor sequence (DTI) Receives: Procedure: Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of micro-structural changes in the trigeminal nerve in essential neuralgia
Describe in patients with unilateral essential trigeminal neuralgia, the micro-structural modifications of the trigeminal nerve observed from data from the DTI sequence compared to the healthy contralateral side
Measured: Day 0 - inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start27 Apr 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051072
- Sponsor's protocol ID
- CLL_2020_37
- Acronym
- SENSE
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2021
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in "Resting State"
- ClinicalTrials.gov ID
- NCT05051072
- Acronym / sponsor ID
- SENSE / CLL_2020_37
- Keywords
- Resting state
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Sep 2021 (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.
Essential trigeminal neuralgia is the most common facial pain. In forms resistant to drug and disabling treatments, surgical treatment may be offered to the patient. The type of intervention will be conditioned by the presence or absence of a vasculo-nervous conflict objectified by MRI(Magnetic resonance imaging) Morphological MRI with contrast injection does not always allow an accurate assessment of trigeminal nerve damage in patients with essential facial neuralgia. Despite advances in the anatomical definition of high-resolution MRI, the correlation between a vascular conflict visible on MRI and present during surgery and prolonged postoperative clinical improvement remains insufficient These data raise the question of additional imaging sequences to assess the distressing characteristics of NT in addition to the usual anatomical criteria for compression By performing during morphological MRI two additional sequences, one in diffusion tensor (DTI) and one in resting state (fMRI), we could better characterize the achievement of NT
The contribution of new imaging sequences in the context of essential trigeminal neuralgia treated with microvascular decompression (MVD) would:
1/improve the diagnostic criteria for suffering and compression of the NT (trigeminal nerve) 2 / define objective prognostic criteria for the effectiveness of surgery, particularly in the context of unusual clinical symptoms or moderate conflict on MRI (Magnetic resonance imaging) 3 / to analyze more precisely the causes of recurrence at a distance from surgery and help in the decision of re-intervention Our main hypothesis: the addition of a diffusion tensor sequence and sequences (allowing functional brain analysis) in addition to standard anatomical MRI in the assessment of a vasculo-nervous conflict would allow us to better characterize involvement of the trigeminal nerve in essential facial neuralgia. It also helps guide therapeutic management and surgical indications.
This is a prospective, monocentric cohort study. It will be offered to patients referred to neurosurgery or to the pain assessment and treatment center for assessment and management of a neuralgia of the essential trijumeau unilateral.
Detailed description
Name:
MRI in morphological sequence, diffusion tensor and resting functional
Description:
The MR exam will be performed on the Neuroradiology 3 Tesla (Philips) MR according to the following protocol:
- Standard anatomical sequences T1, FLAIR, TOF, DRIVE, sequence centered on the V after injection of gadolinated contrast product as part of standard care
- Diffusion tensor sequence (DTI) It allows the analysis of encephalic white matter beams in healthy subjects as well as in many pathologies
- resting state sequence (fMRI) This sequence is based on the spontaneous correlation of the BOLD signal (blood-oxygen level dependent) between different distant brain regions.
- The total duration of the exam will be about 45 minutes, including 15 minutes for the sequences added by the search.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI in morphological sequence, diffusion tensor and resting functional | Other | Procedure: Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia* standard anatomical sequences T1, FLAIR (Fluid Attenuated Inversion Recovery), TOF(Time-of-flight MR angiography) , DRIVE, sequence centered on the V after injection of gadolinated contrast product as part of routine care, * diffusion tensor sequence (DTI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18 years and over);
- Supported in the neurosurgery department or at the assessment and treatment center for pain for unilateral essential trigeminal neuralgia with search for vasculo-nervous conflict;
Key exclusion criteria (5 listed)
- Patient with neurodegenerative or inflammatory neurological pathology;
- Patient who has already been operated on for a DMV;
- Absolute contraindication to MRI
- Patient benefiting from a legal protection measure; with impaired judgment skills or unable to receive information;
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgiaAssessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia | Procedure or surgery | MRI in morphological sequence, diffusion tensor and resting functional |
Primary outcome
Assessment of micro-structural changes in the trigeminal nerve in essential neuralgia
Time frame: Day 0 - inclusion
Describe in patients with unilateral essential trigeminal neuralgia, the micro-structural modifications of the trigeminal nerve observed from data from the DTI sequence compared to the healthy contralateral side
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 11 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia in people with Trigeminal Neuralgia and Microvascular Decompression Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of micro-structural changes in the trigeminal nerve in essential neuralgia (time frame: Day 0 - inclusion). 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 11 Jun 2025.