search
Back to results

Pulvinar Stimulation in Epilepsy: a Pilot Study (PULSE)

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pulvinar deep brain stimulation
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, pulvinar, seizures, deep brain stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de NeurologieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulvinar stimulation

Arm Description

Medial pulvinar deep brain stimulation

Outcomes

Primary Outcome Measures

Number of seizures
Events will be recorded using a seizure diary

Secondary Outcome Measures

Score of depression
NDDI-E
Score of anxiety
GAD-7
Score of quality of life
QOLIE
Score of epilepsy severity
Chalfont

Full Information

First Posted
December 30, 2020
Last Updated
July 19, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT04692701
Brief Title
Pulvinar Stimulation in Epilepsy: a Pilot Study
Acronym
PULSE
Official Title
Pulvinar Stimulation in Epilepsy: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, pulvinar, seizures, deep brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulvinar stimulation
Arm Type
Experimental
Arm Description
Medial pulvinar deep brain stimulation
Intervention Type
Device
Intervention Name(s)
Pulvinar deep brain stimulation
Intervention Description
Stimulation of the medial pulvinar
Primary Outcome Measure Information:
Title
Number of seizures
Description
Events will be recorded using a seizure diary
Time Frame
Change from baseline to 12 months
Secondary Outcome Measure Information:
Title
Score of depression
Description
NDDI-E
Time Frame
Change from baseline to 12 months
Title
Score of anxiety
Description
GAD-7
Time Frame
Change from baseline to 12 months
Title
Score of quality of life
Description
QOLIE
Time Frame
Change from baseline to 12 months
Title
Score of epilepsy severity
Description
Chalfont
Time Frame
Change from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Pizzo
Phone
753841613
Ext
33
Email
francesca.pizzo@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Bartolomei
Email
fabrice.bartolomei@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier Arnaud
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Service de Neurologie
City
Nice
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Thomas
Email
thomas.p@chu-nice.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pulvinar Stimulation in Epilepsy: a Pilot Study

We'll reach out to this number within 24 hrs