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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Implantable minimaly invasive brain stimulator

    Device

    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 stimulator

    Device

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Precisis US, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: