4 documents found, page 1 of 1
The consequences of the new European reclassification of non-invasive brain sti...
Antal, Andrea; Ganho-Ávila, Ana; Assecondi, Sara; Barbour, Traci; Bjekić, Bjekić; Blumberger, Daniel M.; Bolognini, Nadia; Brunelin, JeromeA significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), including transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems a...
Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates o...
Bikson, Marom; Ganho-Ávila, Ana; Datta, Abhishek; Gillick, Bernadette; Joensson, Morten Goertz; Kim, Sungjin; Kim, Jinuk; Kirton, Adam; Lee, KiwonThe objective and scope of this Limited Output Transcranial Electrical Stimulation 2023 (LOTES-2023) guidance is to update the previous LOTES-2017 guidance. These documents should therefore be considered together. The LOTES provides a clearly articulated and transparent framework for the design of devices providing limited output (specified low-intensity range) transcranial electrical stimulation for a variety ...
Digitalized transcranial electrical stimulation: a consensus statement
Brunoni, André R.; Ekhtiari, Hamed; Antal, Andrea; Auvichayapat, Paradee; Baeken, Chris; Benseñor, Isabela M; Bikson, Marom; Boggio, PauloObjective: Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. The study aim...
Digitalized transcranial electrical stimulation: a consensus statement
Brunoni, Andre R; Ekhtiari, Hamed; Antal, Andrea; Auvichayapat, Paradee; Baeken, Chris; Benseñor, Isabela M; Bikson, Marom; Boggio, PauloObjective: Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. The study aim...