Deep Brain Stimulation for Refractory Trigeminal Neuralgia With a Demyelinating Pontine Lesion

Study Overview
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Brief Summary
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The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine demyelinating 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.

Official Title
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Deep Brain Stimulation for Refractory Trigeminal Neuralgia With a Demyelinating Pontine Lesion: a Pilot Study

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Device: Deep brain stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults of at least 18 years old Refractory trigeminal neuralgia (failure of at least 3 drugs and at least one surgical intervention) Demyelinating pontine lesion proved by MRI in contact with trigeminal nerve tract Exclusion Criteria: Absolute contraindication to MRI Medical contraindication to the procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep brain stimulation<br>Implantation of deep brain stimulation lead within the pontine demyelinating lesion | Device: Deep brain stimulation<br>* Implantation of deep brain stimulation lead within the pontine demyelinating lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead implantation accuracy | Difference between target and actual lead position | 24 months | 
| Pain evolution | Evolution of pain severity after the intervention according to the modified Barrow Neurological Institute (mBNI) grading scale. | 24 months | 
| Complications | Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Deep brain stimulation