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Not yet recruiting NCT07301346

EASEE® System Pivotal Study for the United States of America

No phase Interventional Drug-Resistant Focal Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implantable minimaly invasive brain stimulator, Implantable minimaly invasive brain stimulator.
Who it may be relevant to
Registry conditions: Drug-Resistant Focal Epilepsy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Interventions

  • 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.

Primary outcome measures

  • Percentage reduction in the monthly seizure rate [Effectiveness] [Time frame: Baseline and months 5 and 6]
  • Incidence of Serious Adverse Events [Safety and Tolerability] [Time frame: From implant to days 28 and 84 post-implant]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07301346 · CV08-048

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗