EASEE® System Pivotal Study for the United States of America (EASEE4US)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Drug-Resistant Focal Epilepsy
• Intervention / Treatment: Device: Implantable minimaly invasive brain stimulator; Device: Implantable minimaly invasive brain stimulator

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Perry Rice; Phone Number: +49 6221 6559321; Email: p.rice@precisis.de
• Study Contact Backup: Name: Aude Yulzari; Phone Number: +49 6221 6559321; Email: a.yulzari@precisis.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not.	Device: Implantable minimaly invasive brain stimulator; 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.; Device: Implantable minimaly invasive brain stimulator; 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.
Sham Comparator: Control group; Participants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not.	Device: Implantable minimaly invasive brain stimulator; 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.; Device: Implantable minimaly invasive brain stimulator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	From implant to days 28 and 84 post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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).	Baseline to 6 months
Quarterly Seizure Frequency Evaluation	Percentage change in the quarterly seizure frequency between baseline and one year after stimulation start	Baseline to 18 months

Collaborators and Investigators

• Sponsor: Precisis US, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Epilepsy; Neurostimulation; EASEE System; Precisis; Focal Cortex Stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: CV08-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes