EASEE® System Pivotal Study for the United States of America

N/ANot Yet RecruitingNCT07301346

Precisis US, Inc.200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Drug-Resistant Focal Epilepsy

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: From implant to days 28 and 84 post-implant

Secondary Outcomes

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

Time frame: 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).

Time frame: 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).

Time frame: Baseline to 6 months

Quarterly Seizure Frequency Evaluation

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

Time frame: Baseline to 18 months