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1 Hypercapnic challenge while participant is awake

Hospices Civils de Lyon Épilepsie

Suivi actif Non applicable

Résumé

1 Hypercapnic challenge while participant is awake est développé par Hospices Civils de Lyon. Le traitement est actuellement en Non applicable. Il est associé à Épilepsie. Son objectif thérapeutique principal est À vérifier. Le statut actuel est : suivi actif.

À vérifier

À vérifier
Non applicable
Hospices Civils de Lyon
France
Despite the continuous development of new antiseizure medications over the past 25 years, 30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, like cognitive dysfunctions, sleep-disordered breathing or Sudden and Unexpected Death in Epilepsy (SUDEP). SUDEP typically occurs during sleep, after a nocturnal seizure, and primarily results from a postictal central respiratory dysfunction in patients with generalized convulsive seizure (GCS), suggesting that interaction between respiratory dysfunction and sleep state may play a role in its pathophysiology. Post-mortem data in SUDEP patients showed alteration of neuronal populations involved in respiratory control in the medulla. Accordingly, pharmacologic strategies aimed at reducing the severity of postictal respiratory dysfunction has appeared as one of the most promising way to prevent SUDEP. However, no encouraging result has hitherto been reported. Interconnections between the complex network that regulates arousal and sleep and the respiratory network are numerous. They primarily include the relation between chemosensitive regulation and arousal system to ensure asphyxia-induced arousal (i.e. arousal to elevated CO2), especially through serotonin (5HT)-dependent connections in brain stem. The link between alterations of the brainstem networks involved in arousal regulation and respiratory dysfunction has not been characterized in patients with epilepsy yet. Like 5HT, adenosine is deeply implicated in the regulation of sleep and central respiratory control. Seizures transiently increase adenosine extracellular levels. Adenosine physiological effects in the brain are mediated through the activation of two types of Adenosine receptors (ARs), A1Rs and A2ARs. Extracellular adenosine promotes sleep via A1R-dependant inhibition of glutamatergic neurons in the basal forebrain, but also via A2AR-dependant activation of neurons in the nucleus accumbens. Respiration is also inhibited by A1R and A2AR. Most importantly, it has been shown that drug-resistant epilepsy is associated with long-term alterations of ARs cortical expression. However, whether or not a similar epilepsy-related plasticity of ARs occurs in the brainstem and may participate to chronic arousal and respiratory dysfunction in epilepsy has never been investigated. Considering the tight interplay between central respiratory control, arousal regulation and brainstem adenosine, the main hypothesis of the BRAVE study is that epilepsy might result in alterations of the distribution of A1Rs in the brainstem structures involved in respiratory regulation and/or arousal control, especially in the brainstem structures involved in respiratory regulation under hypercapnic condition. The study combines clinical respiratory characterization, morphological, functional and metabolic imaging, using the hybrid simultaneous 3T MRI-PET scanner (Siemens Biograph mMR) of the CERMEP. Combining PET with anatomical and functional MR imaging enables non-invasively in vivo mapping of receptor binding and functional neuronal assessment of a physiological task in the entire brain with high spatial resolution. Investigators already performed fMRI study of respiratory centers, showing number of functional changes in brainstem regions participating to the central control of respiration, including reduced activation during breath-holding fMRI, in patients with epilepsy. The BRAVE study will use the same respiratory paradigm as the one used in this past study. PET imaging will be focused on A1R, using \[18F\]CPFPX, a selective A1R antagonist.
2026-08-07

Début phase actuelle
Non disponible dans les sources synchronisées
Timeline clinique

Non applicable
Préclinique
Phase 1
Phase 2
Phase 3
Approuvé

Objectif scientifique de l’étude

classification automatique vérifiable
À vérifier Confiance automatique : 0%

Description affichée depuis l’essai compatible NCT07249034, afin d’éviter le mélange entre plusieurs indications d’une même molécule.

Contrôle de cohérence : 85/100

L’objectif est absent ou classé « Autre » et doit être recalculé à partir du protocole.

Transparence et qualité de la fiche

données vérifiables
ClassificationÀ vérifier
Confiance de la fiche85 %
Source principaleSource officielle ou publication indexée
Dernière vérification2026-08-07
Anomalies détectées1
Validation humaineValidation humaine non effectuée
Donnée issue d’une source Donnée normalisée automatiquement Interprétation algorithmique

Classification scientifique multi-axes

ne pas confondre statut et résultat
État de l’étudeRecrutement en cours
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable

Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.

Indicateurs factuels

sans score subjectif
Phase enregistréeNon applicable
Études associées1
Publications associées2
Statut consolidéSuivi actif

Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.

Historique factuel de la molécule

6 événement(s) daté(s)

Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.

DateÉvénementSource
2026-08-07Début de l’étudeNCT07249034Registre d’essai clinique
2026-08-07Dernière mise à jour des données1 Hypercapnic challenge while participant is awakeBiomedical Watch
2026-08-13Création de l’enregistrementNCT07249034Registre d’essai clinique
2026-08-16PublicationUpper airway resistance during progressive hypercapnia and progressive hypoxia in normal awake subjects.Respiration physiology
2026-08-16PublicationCatecholaminergic neurons projecting to the paraventricular nucleus of the hypothalamus are essential for cardiorespiratory adjustments to hypoxia.American journal of physiology. Regulatory, integrative and comparative physiology
2028-10-07Fin de l’étude prévue / enregistréeNCT07249034Registre d’essai clinique

Début phase actuelle
Non disponible dans les sources synchronisées
Essais cliniques liés

1 essai(s)
NCT Titre Phase Statut administratif Pays Sponsor
NCT07249034 BRAVE — Impact of Epilepsy on the Brainstem Adenosine Pathway and Its Relation With Arousal and Respiratory Reactivity Non applicable NOT_YET_RECRUITING France Hospices Civils de Lyon

Publications liées

2 publication(s)

Publications liées

2 publication(s)
Titre PMID DOI Journal Date
Upper airway resistance during progressive hypercapnia and progressive hypoxia in normal awake subjects. Voir source 11084201 10.1016/s0034-5687(00)00189-4 Respiration physiology
Catecholaminergic neurons projecting to the paraventricular nucleus of the hypothalamus are essential for cardiorespiratory adjustments to hypoxia. Voir source 26157062 10.1152/ajpregu.00540.2014 American journal of physiology. Regulatory, integrative and comparative physiology

Sources officielles

liens de recherche

Dernière mise à jour des données : 2026-08-07

Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.