CLOSEDLOOPEstimulación Magnética Transcraneal en Bucle Cerrado para Terapia Cerebral Personalizada
Colección de datos
Recopilados desde hoy en adelante - ProspectivoCohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 1 de octubre de 2024
Fecha en la que se inscribió al primer participante.Transcranial magnetic stimulation (TMS) is a widely used tool for exploring brain function in humans (Siebner et al. et al., 2022), which has led to new therapeutics for various psychiatric and neurological disorders (Lefaucheur et al., 2020). However, the open-loop use of this technique has raised questions about its operating principle, due to the high degree of heterogeneity of results and the small to medium observed effect sizes (Zrenner and Ziemann, 2023). To increase the response rate, it has been suggested to individualize stimulation, by adapting the TMS parameters (i.e. delivered dose, target dose, targeting, timing, etc.) to instantaneous estimates of brain brain state. Such an approach, known as closed-loop closed-loop stimulation, is currently one of the main challenges challenges in this field (closed-loop brain state-dependent stimulation). To this end, we are focusing on the combination of robotic TMS and electroencephalography (EEG) (Hernandez-Pavon et al. al., 2023). The closed-loop stimulations using this combination developed to date have two limitations: (i) they are not adaptive and focus focus mainly on calculating the phase of brain oscillations to trigger stimulation and (ii) are limited to central cortical (sensorimotor) areas, where the EEG signal-to-noise ratio is optimal. This project aims to develop closed-loop TMS-EEG protocols that overcome these two limitations: (i) by incorporating adaptive decision modeling (AutoHS model, Harquel et al. 2017) to optimize several parameters in parallel (coil location, orientation, intensity) while using a wider range of EEG markers (evoked potentials, oscillatory activity strength, connectivity, etc.), and (ii) by integrating real-time EEG pre-processing to access any cortical target (including frontal, temporal and occipital lobes).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 40 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Inclusion Criteria: * Signed informed consent * Having undergone a medical examination prior to participation in research * Affiliation with or beneficiary of a social security scheme Exclusion Criteria: * Contraindications (CI) to MRI, EEG, TMS practice * Existence of a severe general medical condition: cardiac, respiratory, hematological, renal, hepatic, cancerous, * Regular use of anxiolytics, sedatives, antidepressants, neuroleptics, * Characterized psychiatric pathology, * Suspicion of alcohol ingestion prior to the examination, * Participation in other interventional research protocols in progress with exclusion period or in the preceding week. * Persons covered by articles L1121-5 to L1121-8 of the CSP (French Public Health Code) (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons under legal protection or unable to express their consent). \- Personnel with a hierarchical link to the principal investigator
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios