iVEAcare — Biomedical Watch V2

Traitements2programmes

Essais1liés

Publications1liées

SourceDBlocale

Traitements

2

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
iVEAcare Neuromodulation SystemThe purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy. The main questions it aims to answer are: What medical problems do participants have when being implanted with and using the iVEAcare system? Does the iVEAcare neurostimulator reduce seizure frequency and severity in patients with drug-resistant epilepsy? Does the iVEAcare neurostimulator improve quality of life in patients with drug-resistant epilepsy? All participants will be implanted with an iVEAcare neurostimulator, and researchers will look at whether any medical problems are caused by the implant procedure or device, and how stimulation changes seizure frequency and severity and participant quality of life compared to when the participant enrolled. Participants will: Be implanted with an iVEAcare device. Visit the clinic 1-month, 3-months, 6-months, 1-year, 18-months and then annually through 5 years where they will be asked to answer questionnaires about their seizures and quality of life. Keep a diary of the number of seizures they have each day.	Épilepsie	Non applicable	À vérifier	Australia	À vérifier
iVEAcare Neuromodulation SystemThe purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy. The main questions it aims to answer are: What medical problems do participants have when being implanted with and using the iVEAcare system? Does the iVEAcare neurostimulator reduce seizure frequency and severity in patients with drug-resistant epilepsy? Does the iVEAcare neurostimulator improve quality of life in patients with drug-resistant epilepsy? All participants will be implanted with an iVEAcare neurostimulator, and researchers will look at whether any medical problems are caused by the implant procedure or device, and how stimulation changes seizure frequency and severity and participant quality of life compared to when the participant enrolled. Participants will: Be implanted with an iVEAcare device. Visit the clinic 1-month, 3-months, 6-months, 1-year, 18-months and then annually through 5 years where they will be asked to answer questionnaires about their seizures and quality of life. Keep a diary of the number of seizures they have each day.	Épilepsie	Non applicable	À vérifier	Australia	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
iVEAcare Neuromodulation System	Épilepsie	Non applicable	NCT07640191	iVEAcare-FS — Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy	RECRUITING

Publications

1

Molécule	Indication / population	Titre	Journal	Date
iVEAcare Neuromodulation System		Application of kilohertz-frequency block to mitigate off-target motor effects of vagus nerve stimulation in swine.	Nature communications