Clinical Trial

Pulvinar Stimulation in Epilepsy: a Pilot Study

Study acronym: PULSE
Completed
View on ClinicalTrials.gov →
Summary
Deep brain stimulation (DBS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated, and vagal nerve stimulation (VNS) demonstrated no efficacy. Benefits such as reduction of seizure frequency have been shown for thalamic stimulation of the anterior thalamic nucleus (ANT), however it has limited efficacy and non-optimal neurocognitive outcome, making the search for other targets crucial in this context. We propose a novel target for DBS stimulation in drug-resistant epilepsy namely the medial pulvinar thalamic nucleus (PuM). This target has been chosen based on previous retrospective studies demonstrating that PuM is involved during focal seizures and in loss of consciousness and seizure termination. PuM stimulation also showed potential encouraging results based on the feasibility and safetu studies recently published. The main objective is to obtain a significant percentage of seizure reduction after 12 months of PuM stimulation compared to baseline period. Quality of life and the relationship with psychiatric and cognitive comorbidities will also be assessed.
Protocol Amendment History 2 changes
critical Trial completed 2026-08-11
minor Completion moved earlier: 2026-10-23 -> 2026-07-08 2026-08-11
Trial Details
NCT Number NCT04692701
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Epilepsy
Enrollment 12 participants
Start Date 2021-01-15
Primary Completion 2023-10-23 (estimated)
Study Completion 2026-07-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-10