Trigeminal NeuralgiaPhase 1NCT05451251
Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion
A Phase 1 study testing Deep brain stimulation in people with Trigeminal Neuralgia, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2024to Oct 2026
- Phase
- Phase 1
- 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
- Adults of at least 18 years old
- Refractory trigeminal neuralgia : failure of at least 3 drugs and at least two lesioning surgical interventions (radiosurgery, percutaneous rhizotomy, or open rhizotomy).
- Pontine lesion proved by MRI in contact with trigeminal nerve tract
Who cannot join
- Absolute contraindication to MRI
- Medical contraindication to the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christian Iorio-Morin, MD, PhD, FRCS(C) contact
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5H3
Mélodie Grondin-Lavigne, MD MSc candidate, 819-346-1110 ext. 15130, melodie.grondin-lavigne@usherbrooke.ca
About this study
Official title: Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion: a Pilot Study
The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis.
These patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief.
Hoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Deep brain stimulation
- Keywords
- Multiple sclerosis, Deep brain stimulation, Pontine lesion
- Medical subject headings
- Trigeminal Neuralgia, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Implantation of deep brain stimulation lead within the pontine lesion
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation | Experimental | Implantation of deep brain stimulation lead within the pontine lesion Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrating the feasibility of the intervention by assessing protocol completion without deviation
Protocol completion defined by:
- Lead implantation with success
- Adjustment of stimulation parameters to minimize adverse effects
- Minimal follow-up of 6 months after intervention
Measured: 24 months
Secondary outcomes (7)
Lead implantation accuracy
Difference between target and actual lead position
Measured: 24 months
Pain evolution
Evolution of pain severity after the intervention according to the modified Barrow Neurological Institute (mBNI) grading scale.
Measured: 24 months
Facial numbness
Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol.
Measured: 24 months
Complications
Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale.
Measured: 24 months
Quality of life progression
Assessed by the Brief Pain Inventory-Facial (BPI-Facial)
Measured: 24 months
Patient acceptability of the procedure
Assessed by a Likert scale with a maximum score of 8. A low score on this scale indicates low acceptability of the surgical procedure, while a high score indicates high acceptability.
Measured: 24 months
Patient global impression of change
Assessed by The Patient Global Impression of Change (PGIC) questionnaire with a maximum score of 18. A low score indicates a low impression of change while a high score indicates a high impression of change.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start15 Oct 2024
- Primary completion15 Oct 2025 (estimated)
- Study completionOct 2026 (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 Université de SherbrookeThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451251
- Sponsor's protocol ID
- 2025-4672
- Status last verified
- Nov 2024
- First submitted
- 5 Jul 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Open on request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion: a Pilot Study
- ClinicalTrials.gov ID
- NCT05451251
- Acronym / sponsor ID
- 2025-4672
- Conditions
- Trigeminal Neuralgia
- Keywords
- Multiple sclerosis, Deep brain stimulation, Pontine lesion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 Jul 2022 (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.
The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis.
These patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief.
Hoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation | Experimental | Device: Deep brain stimulationImplantation of deep brain stimulation lead within the pontine lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of at least 18 years old
- Refractory trigeminal neuralgia : failure of at least 3 drugs and at least two lesioning surgical interventions (radiosurgery, percutaneous rhizotomy, or open rhizotomy).
- Pontine lesion proved by MRI in contact with trigeminal nerve tract
Key exclusion criteria (2 listed)
- Absolute contraindication to MRI
- Medical contraindication to the procedure
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 |
|---|---|---|
| Deep brain stimulationImplantation of deep brain stimulation lead within the pontine lesion | Device | Deep brain stimulation |
Primary outcome
Demonstrating the feasibility of the intervention by assessing protocol completion without deviation
Time frame: 24 months
Protocol completion defined by: * Lead implantation with success * Adjustment of stimulation parameters to minimize adverse effects * Minimal follow-up of 6 months after intervention
7 secondary outcomes
Lead implantation accuracy
Time frame: 24 months
Pain evolution
Time frame: 24 months
Facial numbness
Time frame: 24 months
Complications
Time frame: 24 months
Quality of life progression
Time frame: 24 months
Patient acceptability of the procedure
Time frame: 24 months
Patient global impression of change
Time frame: 24 months
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 12 Dec 2024.
- Individual participant dataSharing planned: Yes. Open on request.
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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.
Christian Iorio-Morin, MD, PhD, FRCS(C) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deep brain stimulation in people with Trigeminal Neuralgia, run by Université de Sherbrooke at 1 site in Canada.
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 3 inclusion and 2 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 12 Dec 2024. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christian Iorio-Morin, MD, PhD, FRCS(C) (819-346-1110 ext. 16365, Christian.Iorio-Morin@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrating the feasibility of the intervention by assessing protocol completion without deviation (time frame: 24 months). 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 12 Dec 2024.