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NCT Number: NCT07301346

EASEE® System Pivotal Study for the United States of America

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. 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? 2. 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

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Key information

Conditions

Drug-Resistant Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Implantable minimaly invasive brain stimulator

Device

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Seizure Frequency Responder Rate

    Time frame: from Baseline to 6 months

    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

  2. Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome]

    Time frame: Baseline to 6 months

    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).

  3. Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome]

    Time frame: Baseline to 6 months

    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).

  4. Quarterly Seizure Frequency Evaluation

    Time frame: Baseline to 18 months

    Percentage change in the quarterly seizure frequency between baseline and one year after stimulation start

Study contacts

Contact information is provided by the study sponsor or research team.

Aude Yulzari

CONTACT

[email protected]

+49 6221 6559321

Perry Rice

CONTACT

[email protected]

+49 6221 6559321

Sponsors and collaborators

Lead sponsor

Precisis US, Inc.

Industry

Registry information

Acronym: EASEE4US

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Dec 24, 2025
Registry last updated
May 1, 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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