Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

NCT05451251 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 2025-4672
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia

Keywords

Multiple sclerosis; Deep brain stimulation; Pontine lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Lead implantation accuracy

  24 months

• Pain evolution

  24 months

• Facial numbness

  24 months

• Complications

  24 months

• Quality of life progression

  24 months

Study Arms (1)

Deep brain stimulation

EXPERIMENTAL

Implantation of deep brain stimulation lead within the pontine lesion

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

Implantation of deep brain stimulation lead within the pontine lesion

Deep brain stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Absolute contraindication to MRI
• Medical contraindication to the procedure

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5H3, Canada

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia; Multiple Sclerosis

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: October 15, 2024
• Primary Completion: October 15, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)