EASEE® System Pivotal Study for the United States of America
ConditionDrug-Resistant Focal Epilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPrecisis US, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Diagnostic of non-epileptic seizures
Active idiopathic generalized epilepsy
Recent status epileptics (<12 months)
Clinically significant or unstable medical condition
Trial design
Treatments tested in this trial
- Implantable minimaly invasive brain stimulator
- Implantable minimaly invasive brain stimulator
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov