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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep brain stimulation | Experimental | Implantation of deep brain stimulation lead within the pontine lesion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | Implantation of deep brain stimulation lead within the pontine lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrating the feasibility of the intervention by assessing protocol completion without deviation | Protocol completion defined by:
| 24 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Iorio-Morin, MD, PhD, FRCS(C) | Contact | 819-346-1110 | 16365 | Christian.Iorio-Morin@usherbrooke.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Sherbrooke (CHUS) | Recruiting | Sherbrooke | Quebec | J1H 5H3 | Canada |
Open on request.
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 24 months |
| Facial numbness | Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol. | 24 months |
| Complications | Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale. | 24 months |
| Quality of life progression | Assessed by the Brief Pain Inventory-Facial (BPI-Facial) | 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. | 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. | 24 months |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |