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Recruiting NCT05451251

Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

Phase I Interventional Trigeminal Neuralgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep brain stimulation.
Who it may be relevant to
Registry conditions: Trigeminal Neuralgia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device Deep brain stimulation
    Implantation of deep brain stimulation lead within the pontine lesion

Primary outcome measures

  • Demonstrating the feasibility of the intervention by assessing protocol completion without deviation [Time frame: 24 months]
Secondary outcome measures (7)
  • Lead implantation accuracy [Time frame: 24 months]
  • Pain evolution [Time frame: 24 months]
  • Facial numbness [Time frame: 24 months]
  • Complications [Time frame: 24 months]
  • Quality of life progression [Time frame: 24 months]
  • Patient acceptability of the procedure [Time frame: 24 months]
  • Patient global impression of change [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre Hospitalier Universitaire de Sherbrooke (CHUS) — Sherbrooke

Identifiers

NCT: NCT05451251 · 2025-4672

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗