NCT04692701: PULSE

Pulvinar Stimulation in Epilepsy: a Pilot Study

Active, enrolled NA Last updated 10 February 2026

What this trial tests

NA trial testing Pulvinar deep brain stimulation in Epilepsy in 12 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 January 2021

Primary endpoint
23 October 2023

23 October 2026

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	15 January 2021
Primary completion	23 October 2023
Estimated completion	23 October 2026
Sites	1 location across France

Drugs / interventions tested

• Pulvinar deep brain stimulation

Conditions studied

• Epilepsy — all drugs for Epilepsy →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

Adults 18 to 60, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stimulation to probe, excite, and inhibit the epileptic brain.
   Frauscher B, Bartolomei F, Baud MO, Smith RJ, et al · · 2023 · cited 23× · PMID 37194746 · DOI 10.1111/epi.17640
2. Epilepsy Characteristics in Neurodevelopmental Disorders: Research from Patient Cohorts and Animal Models Focusing on Autism Spectrum Disorder.
   Chakraborty S, Parayil R, Mishra S, Nongthomba U, et al · · 2022 · cited 18× · PMID 36142719 · DOI 10.3390/ijms231810807
3. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
4. Medial Pulvinar Stimulation in Temporal Lobe Epilepsy: A Literature Review and a Hypothesis Based on Neuroanatomical Findings.
   Kalamatianos T, Mavrovounis G, Skouras P, Pandis D, et al · · 2023 · cited 12× · PMID 37025746 · DOI 10.7759/cureus.35772
5. Medial pulvinar stimulation for focal drug-resistant epilepsy: interim 12-month results of the PULSE study.
   Pizzo F, Carron R, Laguitton V, Clement A, et al · · 2024 · cited 11× · PMID 39719976 · DOI 10.3389/fneur.2024.1480819
6. Bilateral pulvinar responsive neurostimulation for bilateral multifocal posteriorly dominant drug resistant epilepsy.
   Wang R, Sacknovitz A, Vazquez S, Dominguez J, et al · · 2024 · cited 6× · PMID 39435755 · DOI 10.1002/epi4.13068
7. Advanced Temporally-Spatially Precise Technologies for On-Demand Neurological Disorder Intervention.
   Chen X, Gong Y, Chen W. · · 2023 · cited 4× · PMID 36929323 · DOI 10.1002/advs.202207436
8. Letter to Brain-responsive corticothalamic stimulation in the pulvinar nucleus for the treatment of regional neocortical epilepsy: A case series.
   Pizzo F, Carron R, Bartolomei F. · · 2022 · cited 1× · PMID 35917183 · DOI 10.1002/epi4.12611