Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

Phase 1

Recruiting

• Conditions: Trigeminal Neuralgia
• Interventions: Device: Deep brain stimulation

• Registration Number: NCT05451251
• Lead Sponsor: Université de Sherbrooke

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-11
• Study Start: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-10-15
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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

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Exclusion Criteria

• Absolute contraindication to MRI
• Medical contraindication to the procedure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep brain stimulation	Deep brain stimulation	Implantation of deep brain stimulation lead within the pontine demyelinating lesion

Primary Outcome Measures

Name	Time	Method
Demonstrating the feasibility of the intervention by assessing protocol completion without deviation	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

Secondary Outcome Measures

Name	Time	Method
Lead implantation accuracy	24 months	Difference between target and actual lead position
Pain evolution	24 months	Evolution of pain severity after the intervention according to the modified Barrow Neurological Institute (mBNI) grading scale.
Facial numbness	24 months	Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol.
Complications	24 months	Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale.
Quality of life progression	24 months	Assessed by the Brief Pain Inventory-Facial (BPI-Facial)
Patient acceptability of the procedure	24 months	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.
Patient global impression of change	24 months	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.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke (CHUS); 🇨🇦 Sherbrooke, Quebec, Canada