NeuroPace — Biomedical Watch V2

Traitements6programmes

Essais3liés

Publications5liées

SourceDBlocale

Traitements

6

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
NeuroPace RNS SystemThe NeuroPace RNS System is FDA-approved for adults with drug-resistant focal epilepsy but is not yet approved for adolescents. This study uses real-world data to evaluate the RNS System's safety and effectiveness in adolescents aged 12 through 17 who have already received the device in routine clinical practice. Data will come from patient-authorized electronic health records and patient-reported outcomes collected through a central study site, not a traditional trial infrastructure. Up to 100 evaluable patients across the United States sites will be enrolled, with results intended to support expansion of the RNS System's approved indication to include this adolescent population.	Épilepsie	À vérifier	À vérifier	United States	À vérifier
RNS SystemTo generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS.	Épilepsie	Phase 2	À vérifier	United States	À vérifier
RNS® SystemThe RNS® System LTT study is designed to assess the ongoing safety and to evaluate the long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.	Épilepsie	Phase 4	À vérifier	United States	À vérifier
RNS® SystemThe RNS® System LTT study is designed to assess the ongoing safety and to evaluate the long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.	Épilepsie	Phase 4	À vérifier	United States	À vérifier
NeuroPace RNS SystemThe NeuroPace RNS System is FDA-approved for adults with drug-resistant focal epilepsy but is not yet approved for adolescents. This study uses real-world data to evaluate the RNS System's safety and effectiveness in adolescents aged 12 through 17 who have already received the device in routine clinical practice. Data will come from patient-authorized electronic health records and patient-reported outcomes collected through a central study site, not a traditional trial infrastructure. Up to 100 evaluable patients across the United States sites will be enrolled, with results intended to support expansion of the RNS System's approved indication to include this adolescent population.	Épilepsie	À vérifier	À vérifier	United States	À vérifier
RNS SystemTo generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS.	Épilepsie	Phase 2	À vérifier	United States	À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
RNS System	Épilepsie	Phase 2	NCT05339126	RNS System LGS Feasibility Study	ACTIVE_NOT_RECRUITING
NeuroPace RNS System	Épilepsie	À vérifier	NCT07823465	AURORA — RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study	ENROLLING_BY_INVITATION
RNS® System	Épilepsie	Phase 4	NCT00572195	RNS® System LTT Study	COMPLETED

Publications

5

Molécule	Indication / population	Titre	Journal	Date
RNS® System		Clusters in Thalamic iEEG Spectral Features Reveal Sleep/Wake Differences Over Time.	Journal of clinical neurophysiology : official publication of the American Electroencephalographic Society
RNS® System		Numerical investigations around the Gallavotti-Cohen fluctuation theorem on log-lattices.	Philosophical transactions. Series A, Mathematical, physical, and engineering sciences
RNS® System		Responsive neurostimulation in pediatric drug-resistant epilepsy: A systematic review and meta-analysis of seizure and non-seizure outcomes, safety, and predictors of response.	Seizure
RNS® System		Responsive stimulation of the thalamus for idiopathic generalized epilepsy: Results of the randomized controlled NAUTILUS trial through 18 months.	Epilepsia
RNS® System		Thalamocortical seizure onset patterns in drug-resistant focal epilepsy.	Brain communications