Drug-Resistant Focal Epilepsy
Conditions
Keywords
EASEE System, Precisis, Neurostimulation, Epilepsy, Focal Cortex Stimulation
Brief summary
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
DEVICEImplantable 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.
Sponsors
Precisis US, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage reduction in the monthly seizure rate [Effectiveness] | Baseline and months 5 and 6 | 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. |
| Incidence of Serious Adverse Events [Safety and Tolerability] | From implant to days 28 and 84 post-implant | * Acute Serious Adverse Event incidence in the study population * Short term chronic Serious Adverse Event incidence in the study population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure Frequency Responder Rate | from Baseline to 6 months | 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 |
| Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome] | Baseline to 6 months | 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). |
| Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome] | Baseline to 6 months | 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). |
| Quarterly Seizure Frequency Evaluation | Baseline to 18 months | Percentage change in the quarterly seizure frequency between baseline and one year after stimulation start |
Countries
United States
Contacts
CONTACTPerry Rice
CONTACTAude Yulzari
Outcome results
None listed