Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

Phase 1RecruitingNCT05451251

Université de Sherbrooke6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Trigeminal Neuralgia

Interventions

Deep brain stimulation

Implantation of deep brain stimulation lead within the pontine lesion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Absolute contraindication to MRI * Medical contraindication to the procedure

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Christian Iorio-Morin, MD, PhD, FRCS(C)

CONTACT

819-346-1110 Christian.Iorio-Morin@usherbrooke.ca

Data from ClinicalTrials.gov

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