A Phase 1 interventional study of Deep brain stimulation in Trigeminal Neuralgia, sponsored by Université de Sherbrooke. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Université de Sherbrooke · Phase 1, Interventional, and Treatment
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.
135 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's planned enrollment of 6 is below the median of 40 across 92 interventional studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implantation of deep brain stimulation lead within the pontine lesion
Device: Deep brain stimulation
Implantation of deep brain stimulation lead within the pontine lesion
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
Time frame: 24 months
Lead implantation accuracy
Difference between target and actual lead position
Time frame: 24 months
Pain evolution
Evolution of pain severity after the intervention according to the modified Barrow Neurological Institute (mBNI) grading scale.
Time frame: 24 months
Facial numbness
Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol.
Time frame: 24 months
Complications
Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale.
Time frame: 24 months
Quality of life progression
Assessed by the Brief Pain Inventory-Facial (BPI-Facial)
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Plan to share: Yes — Open on request.
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Université de Sherbrooke