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Neurostimulation Device

Deep Brain Stimulation for Trigeminal Neuralgia

Phase 1
Recruiting
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Medical contraindication to the procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new technique called deep brain stimulation to treat severe facial pain in patients with multiple sclerosis. The current treatments for this type of pain often don't work well, so researchers want

Who is the study for?
This trial is for adults over 18 with severe facial pain from trigeminal neuralgia that hasn't improved after trying at least three medications and one surgery. They must have an MRI showing a demyelinating lesion in the brainstem touching the trigeminal nerve.
What is being tested?
The study tests deep brain stimulation (DBS) as a new method to relieve intense facial pain caused by trigeminal neuralgia with a pontine lesion, often seen in multiple sclerosis patients where other treatments failed.
What are the potential side effects?
Potential side effects of DBS may include headache, infection at the implant site, bleeding in the brain, stroke-like symptoms, hardware complications like lead migration or device malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My facial pain hasn't improved despite trying 3 drugs and 2 surgeries.
Select...
My MRI shows a lesion in the brainstem touching the trigeminal nerve.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a health condition that makes the procedure unsafe for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Demonstrating the feasibility of the intervention by assessing protocol completion without deviation
Secondary study objectives
Complications
Facial numbness
Lead implantation accuracy
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep brain stimulationExperimental Treatment1 Intervention
Implantation of deep brain stimulation lead within the pontine lesion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep brain stimulation
2010
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
304 Previous Clinical Trials
76,723 Total Patients Enrolled
~4 spots leftby Oct 2025
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