Actively Recruiting
Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion: a Pilot Study
Led by Université de Sherbrooke · Updated on 2024-12-12
6
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach called deep brain stimulation for patients with refractory trigeminal neuralgia caused by a pontine lesion, often seen in multiple sclerosis. These patients suffer from severe facial pain that does not respond to current medical or surgical treatments. The goal is to explore if this novel technique can help control pain by targeting the lesion involved in pain signal generation. The study involves implanting a deep brain stimulation lead directly within the pontine lesion to modulate pain signals. This is a Phase 1 pilot trial where the intervention consists of this device implantation procedure. There is only one treatment group receiving the deep brain stimulation device. Participants will be followed for 24 months to assess whether the procedure can be completed as planned without deviations, the accuracy of lead placement, changes in pain levels, facial numbness, any complications, quality of life changes, patient acceptance of the procedure, and overall patient impression of improvement. The study aims to monitor safety and feasibility over this two-year period.
CONDITIONS
Brief Title
Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults of at least 18 years old
- Diagnosis of refractory trigeminal neuralgia with failure of at least 3 drugs and 2 lesioning surgeries (radiosurgery, percutaneous rhizotomy, or open rhizotomy)
- Presence of a pontine lesion shown by MRI in contact with the trigeminal nerve tract
You will not qualify if you...
- Absolute contraindication to MRI
- Medical contraindication to the deep brain stimulation procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of a deep brain stimulation lead within the pontine lesion.
1 visit (in-person)
Duration - Up to 24 months
Participants are monitored for complications, pain evolution, facial numbness, quality of life progression, and patient acceptability of the procedure.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada, J1H 5H3
Actively Recruiting
Research Team
C
Christian Iorio-Morin, MD, PhD, FRCS(C)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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