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Completed

NCT Number: NCT04692701

Pulvinar Stimulation in Epilepsy: a Pilot Study

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie

Nice, 13385, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • For women of childbearing potential, a pregnancy test must be negative before inclusion.

Exclusion criteria

  • 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 history of attempted suicide in the 6 months prior to inclusion or a score ≥ 2 in item 10 of the Montgomery and Asberg Depression Scale (MADRS).
  • 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
  • Patient currently participating in another clinical trial or having participated in a clinical trial in the month prior to inclusion

Treatment and study plan

Pulvinar deep brain stimulation

Device

Stimulation of the medial pulvinar

Primary outcomes

  1. Number of seizures

    Time frame: Change from baseline to 12 months

    Events will be recorded using a seizure diary

Secondary outcomes

  1. Score of depression

    Time frame: Change from baseline to 12 months

    NDDI-E

  2. Score of anxiety

    Time frame: Change from baseline to 12 months

    GAD-7

  3. Score of quality of life

    Time frame: Change from baseline to 12 months

    QOLIE

  4. Score of epilepsy severity

    Time frame: Change from baseline to 12 months

    Chalfont

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: PULSE

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jan 5, 2021
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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