Tests a brain stimulator device in adults with hard-to-control focal epilepsy
Tests a brain stimulator implant in adults whose focal epilepsy is not controlled by medicines.
Plain-language title generated from the registry record
Registry title: EASEE® System Pivotal Study for the United States of America
Key facts
- Where
- New York, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07301346, who can take part
Where in United States
- Columbia University Irving Medical Center/New York Presbyterian HospitalNew York, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Precisis US, Inc.
- Trial code
- NCT07301346
- Record updated
- 28 August 2026
- Original description
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:Read full original descriptionShow less
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
Inclusion: 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: Diagnostic of non-epileptic seizures; Active idiopathic generalized epilepsy; Clinically significant or unstable medical condition; Recent status epileptics (<12 months); Active psychosis, major depression, suicidal ideation (<6 months); Pregnancy; Implanted with brain stimulation device or active Vagus Nerve Stimulation.