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[Forsøg med enhed, der ikke er godkendt eller godkendt af den amerikanske FDA] (EASEE4US)

27. april 2026 opdateret af: Precisis US, Inc.

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention group
Participants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not.
Enhed: 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.
Enhed: 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.
Sham-komparator: Control group
Participants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not.
Enhed: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage reduction in the monthly seizure rate [Effectiveness]
Tidsramme: 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.
Baseline and months 5 and 6
Incidence of Serious Adverse Events [Safety and Tolerability]
Tidsramme: 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
From implant to days 28 and 84 post-implant

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Seizure Frequency Responder Rate
Tidsramme: 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
from Baseline to 6 months
Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome]
Tidsramme: 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).
Baseline to 6 months
Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome]
Tidsramme: 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).
Baseline to 6 months
Quarterly Seizure Frequency Evaluation
Tidsramme: Baseline to 18 months
Percentage change in the quarterly seizure frequency between baseline and one year after stimulation start
Baseline to 18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Precisis US, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. juli 2030

Datoer for studieregistrering

Først indsendt

27. november 2025

Først indsendt, der opfyldte QC-kriterier

22. december 2025

Først opslået (Faktiske)

24. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CV08-048

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The study results will be submitted for publication in peer-review journal(s) after completion of study endpoints. Research ideas can be shared with the Primary Investigators for analysis.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Drug-Resistant Focal Epilepsy

Kliniske forsøg med Implantable minimaly invasive brain stimulator

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