Pulvinar Stimulation in Epilepsy: a Pilot Study

NCT04692701 | Active Not Recruiting

• 2 other identifiers: 2020-492020-A02119-30
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Keywords

epilepsy; pulvinar; seizures; deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Number of seizures

  Events will be recorded using a seizure diary

  Change from baseline to 12 months

Secondary Outcomes (4)

• Score of depression

  Change from baseline to 12 months

• Score of anxiety

  Change from baseline to 12 months

• Score of quality of life

  Change from baseline to 12 months

• Score of epilepsy severity

  Change from baseline to 12 months

Study Arms (1)

Pulvinar stimulation

EXPERIMENTAL

Medial pulvinar deep brain stimulation

Device: Pulvinar deep brain stimulation

Interventions

Pulvinar deep brain stimulation DEVICE

Stimulation of the medial pulvinar

Pulvinar stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: between 18 and 60 years old
• Focal or multifocal drug-resistant epilepsy not operable or failure of epilepsy surgery
• Vagal nerve stimulation failure (after at least 1 year of treatment or stopped early for worsening seizures)
• Either patients with epilepsy whose characteristics suggest that it may respond better to stimulation of the pulvinar than the anterior thalamic nucleus stimulation (i.e. posterior quadrant epilepsy, motor/premotor epilepsy, operculo-insular epilepsy, temporal plus epilepsy, lateral temporal epilepsy) or/and patients with previous anterior thalamic nucleus stimulation failure (after 2 years of treatment or stopped early for worsening seizures)
• Number of seizures \> 4 / month during the baseline (3 months) and before the V0 for at least 3 months
• Total IQ \> 55
• Give written consent to the study after receiving clear information
• Be a beneficiary or affiliated to a health insurance plan

You may not qualify if:

• Difficulty to read or understand the French language, or inability to understand the information regarding the study.
• Generalized epilepsy
• Presenting contraindication to MRI, a serious intercurrent pathology, a progressive brain tumor.
• Pregnancy or breastfeeding
• Present a surgical or anaesthetic contraindication.
• Require long-term anticoagulant or platelet aggregation therapy.
• Hereditary bleeding disorders of coagulation
• Non obliterated AVM
• History of Herpes virus brain infection
• Total IQ below 55.
• Patients with less than 4 seizures a month
• To be hospitalized under duress (HO / HDT)
• Major under guardianship or curatorship
• Person deprived of liberty by judicial decision

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service de Neurologie

Nice, France, 13385, France

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Olivier Arnaud

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: January 15, 2021
• Primary Completion: October 23, 2023
• Study Completion (Estimated): October 23, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)