Drug-Resistant Focal EpilepsyEASEE4USNCT07301346
EASEE® System Pivotal Study for the United States of America
A study testing Implantable minimaly invasive brain stimulator in people with Drug-Resistant Focal Epilepsy, run by Precisis US, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Drug-Resistant Focal Epilepsy
- What is being tested?
- Implantable minimaly invasive brain stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 1 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult between 18-75 years of age
- Diagnosis of drug-resistant focal epilepsy
- At least four (4) observable seizure manifestations per month
- Stable anti-seizure medication regimen
Who cannot join
- Diagnostic of non-epileptic seizures
- Active idiopathic generalized epilepsy
- Recent status epileptics (<12 months)
- Clinically significant or unstable medical condition
- Active psychosis, major depression, suicidal ideation (<6 months)
- Pregnancy
- Implanted with brain stimulation device or active Vagus Nerve Stimulation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Juan-Luis Alcala-Zemeno, MD, (212)342-8528, ja3908@cumc.columbia.edu
About this study
The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are:
- Is the percentage reduction of monthly seizure rate larger in the Intervention group than in the Control group at the end of the Blinded Phase?
- Is the use of EASEE(R) System safe after up to 28 and up to 84 days?
Read more
Participants will be asked to:
- Complete a seizure diary for the duration of the clinical trial
- Attend study visits for 20 months of their clinical trial participation
- Undergo EASEE(R) System implant
- Not be aware if neurostimulation is delivered during the Blinded Phase (6 months)
- Receive neurostimulation for at least 12 months
- Conditions
- Drug-Resistant Focal Epilepsy
- Being tested
- Implantable minimaly invasive brain stimulator
- Keywords
- EASEE System, Precisis, Neurostimulation, Epilepsy, Focal Cortex Stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable minimaly invasive brain stimulatorDevice
Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is activated (turned ON) for 18 months.
Implantable minimaly invasive brain stimulatorDevice
Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is not activated (turned OFF) for 6 months, than activated (turned ON) for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not. Receives: Device: Implantable minimaly invasive brain stimulator |
| Control group | Sham comparator | Participants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not. Receives: Device: Implantable minimaly invasive brain stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in the monthly seizure rate [Effectiveness]
Percentage reduction in the monthly seizure rate during months 5 and 6 post-randomization compared to 3 months pre-implant baseline in the Intervention group versus the Control group.
Measured: Baseline and months 5 and 6
Incidence of Serious Adverse Events [Safety and Tolerability]
- Acute Serious Adverse Event incidence in the study population
- Short term chronic Serious Adverse Event incidence in the study population
Measured: From implant to days 28 and 84 post-implant
Secondary outcomes (4)
Seizure Frequency Responder Rate
Comparison between study arms of the proportion of patients who reach at least 50 % of monthly seizure frequency reduction between the baseline and the follow-up months 5 and 6
Measured: from Baseline to 6 months
Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome]
Comparison of Beck Depression Inventory (BDI-II) changes form baseline to follow-up month 6 between the study arms. BDI-II scores from 0 (no or minimal depression) to 63 (severe depression).
Measured: Baseline to 6 months
Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome]
Evaluation of Beck Depression Inventory (BDI-II) changes form baseline to follow-up month 6 between in the Intervention group. BDI-II scores between 0 (no or minimal depression) to 63 (severe depression).
Measured: Baseline to 6 months
Quarterly Seizure Frequency Evaluation
Percentage change in the quarterly seizure frequency between baseline and one year after stimulation start
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start31 Oct 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Resistant Focal EpilepsyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precisis US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301346
- Sponsor's protocol ID
- CV08-048
- Acronym
- EASEE4US
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study results will be submitted for publication in peer-review journal(s) after completion of study endpoints. Research ideas can be shared with the Primary Investigators for analysis.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASEE® System Pivotal Study for the United States of America
- ClinicalTrials.gov ID
- NCT07301346
- Acronym / sponsor ID
- EASEE4US / CV08-048
- Conditions
- Drug-Resistant Focal Epilepsy
- Keywords
- EASEE System, Precisis, Neurostimulation, Epilepsy, Focal Cortex Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Precisis US, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 24 Dec 2025 (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.
The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are:
- Is the percentage reduction of monthly seizure rate larger in the Intervention group than in the Control group at the end of the Blinded Phase?
- Is the use of EASEE(R) System safe after up to 28 and up to 84 days?
Participants will be asked to:
- Complete a seizure diary for the duration of the clinical trial
- Attend study visits for 20 months of their clinical trial participation
- Undergo EASEE(R) System implant
- Not be aware if neurostimulation is delivered during the Blinded Phase (6 months)
- Receive neurostimulation for at least 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Implantable minimaly invasive brain stimulatorParticipants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not. |
| Control group | Sham comparator | Device: Implantable minimaly invasive brain stimulatorParticipants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult between 18-75 years of age
- Diagnosis of drug-resistant focal epilepsy
- At least four (4) observable seizure manifestations per month
- Stable anti-seizure medication regimen
Key exclusion criteria (7 listed)
- Diagnostic of non-epileptic seizures
- Active idiopathic generalized epilepsy
- Recent status epileptics (<12 months)
- Clinically significant or unstable medical condition
- Active psychosis, major depression, suicidal ideation (<6 months)
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 |
|---|---|---|
| Implantable minimaly invasive brain stimulatorParticipants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is activated (turned ON) for 18 months. | Device | Intervention group |
| Implantable minimaly invasive brain stimulatorParticipants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is not activated (turned OFF) for 6 months, than activated (turned ON) for 12 months. | Device | Control group |
Primary outcome
Percentage reduction in the monthly seizure rate [Effectiveness]
Time frame: Baseline and months 5 and 6
Percentage reduction in the monthly seizure rate during months 5 and 6 post-randomization compared to 3 months pre-implant baseline in the Intervention group versus the Control group.
Incidence of Serious Adverse Events [Safety and Tolerability]
Time frame: From implant to days 28 and 84 post-implant
* Acute Serious Adverse Event incidence in the study population * Short term chronic Serious Adverse Event incidence in the study population
4 secondary outcomes
Seizure Frequency Responder Rate
Time frame: from Baseline to 6 months
Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome]
Time frame: Baseline to 6 months
Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome]
Time frame: Baseline to 6 months
Quarterly Seizure Frequency Evaluation
Time frame: Baseline to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No. The study results will be submitted for publication in peer-review journal(s) after completion of study endpoints. Research ideas can be shared with the Primary Investigators for analysis.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable minimaly invasive brain stimulator in people with Drug-Resistant Focal Epilepsy, run by Precisis US, Inc. at 1 site in United States.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 28 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perry Rice (+49 6221 6559321, p.rice@precisis.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in the monthly seizure rate [Effectiveness] (time frame: Baseline and months 5 and 6). The study lists 2 primary outcomes in all. 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 28 Aug 2026.