Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

NCT ID: NCT05451251

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Trigeminal Neuralgia

Keywords

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Multiple sclerosis Deep brain stimulation Pontine lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep brain stimulation

Implantation of deep brain stimulation lead within the pontine lesion

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type DEVICE

Implantation of deep brain stimulation lead within the pontine lesion

Interventions

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Deep brain stimulation

Implantation of deep brain stimulation lead within the pontine lesion

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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

Role: CONTACT

Phone: 819-346-1110

Email: [email protected]

Facility Contacts

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Mélodie Grondin-Lavigne, MD MSc candidate

Role: primary

Other Identifiers

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2025-4672

Identifier Type: -

Identifier Source: org_study_id