EpilepsyPULSENCT04692701
Pulvinar Stimulation in Epilepsy: a Pilot Study
A study testing Pulvinar deep brain stimulation in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Pulvinar deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2021to 8 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Epilepsy
- Being tested
- Pulvinar deep brain stimulation
- Keywords
- epilepsy, pulvinar, seizures, deep brain stimulation
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulvinar deep brain stimulationDevice
Stimulation of the medial pulvinar
| Study group | Role | What they receive |
|---|---|---|
| Pulvinar stimulation | Experimental | Medial pulvinar deep brain stimulation Receives: Device: Pulvinar deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seizures
Events will be recorded using a seizure diary
Measured: Change from baseline to 12 months
Secondary outcomes (4)
Score of depression
NDDI-E
Measured: Change from baseline to 12 months
Score of anxiety
GAD-7
Measured: Change from baseline to 12 months
Score of quality of life
QOLIE
Measured: Change from baseline to 12 months
Score of epilepsy severity
Chalfont
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Jan 2021
- Primary completion23 Oct 2023
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier Arnaud, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692701
- Sponsor's protocol ID
- 2020-49
- Other IDs
- 2020-A02119-30
- Acronym
- PULSE
- Status last verified
- Aug 2026
- First submitted
- 30 Dec 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulvinar Stimulation in Epilepsy: a Pilot Study
- ClinicalTrials.gov ID
- NCT04692701
- Acronym / sponsor ID
- PULSE / 2020-49
- Conditions
- Epilepsy
- Keywords
- epilepsy, pulvinar, seizures, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulvinar stimulation | Experimental | Device: Pulvinar deep brain stimulationMedial pulvinar deep brain stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulvinar deep brain stimulationStimulation of the medial pulvinar | Device | Pulvinar stimulation |
Primary outcome
Number of seizures
Time frame: Change from baseline to 12 months
Events will be recorded using a seizure diary
4 secondary outcomes
Score of depression
Time frame: Change from baseline to 12 months
Score of anxiety
Time frame: Change from baseline to 12 months
Score of quality of life
Time frame: Change from baseline to 12 months
Score of epilepsy severity
Time frame: Change from baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Olivier Arnaud study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulvinar deep brain stimulation in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of seizures (time frame: Change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.