Pilot Study of Deep Brain Stimulation in Adults with Refractory Trigeminal Neuralgia and Pontine Lesions

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.

Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion