Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion: a Pilot Study

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 Overview

• Status: Recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Device: Deep brain stimulation

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Christian Iorio-Morin, MD, PhD, FRCS(C); Phone Number: 16365 819-346-1110; Email: Christian.Iorio-Morin@usherbrooke.ca

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • Recruiting
      • Centre hospitalier universitaire de Sherbrooke (CHUS)
      • Contact: Mélodie Grondin-Lavigne, MD MSc candidate; Phone Number: 15130 819-346-1110; Email: melodie.grondin-lavigne@usherbrooke.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep brain stimulation; Implantation of deep brain stimulation lead within the pontine lesion	Device: Deep brain stimulation; Implantation of deep brain stimulation lead within the pontine lesion

What is the study measuring?

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
Facial numbness	Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol.	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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): October 15, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Deep brain stimulation; Pontine lesion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: 2025-4672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Open on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes