Verbal Communication using Intracortical Signals in a Completely Locked In-Patient

Patients with amyotrophic lateral sclerosis (ALS) can lose all muscle-based routes of communication as motor neuron degeneration progresses, and ultimately, they may be left without any means of communication. While others have evaluated communication in people with remaining muscle control, to the best of our knowledge, it is not known whether neural-based communication remains possible in a completely locked-in state (CLIS). With consent and approval of the participant, family, and legal authority for this study, two 64 microelectrode arrays were implanted in the supplementary and primary motor cortex of a CLIS patient with ALS. The patient modulated neural firing rates based on auditory feedback, and he used this strategy to select letters one at a time to form words and phrases to communicate his needs and experiences. This case study provides novel evidence that brain-based volitional communication is possible even in a completely locked-in state. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial The medical procedure was approved by the Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM, The German Federal Institute for Drugs and Medical Devices). The study was declared as a Single Case Study and has received a special authorization (Sonderzulassung) by BfArM, according to 11 of the German Medical Device Law (Medizin-Produkte-Gesetz) on December 20, 2018, with Case Nr. 5640-S-036/18. The Ethical Committee of the Medical Faculty of the Technische Universitaet Muenchen Rechts der Isar provided support to the study on 19 Jan 2019, along with the explicit permission to publish on 17 February 2020. Since it is not a clinical trial it was not registered. ### Funding Statement This research was supported by the Wyss Center for Bio and Neuroengineering, Geneva, Deutsche Forschungsgemeinschaft (DFG BI 195/77-1); German Ministry of Education and Research (BMBF) 16SV7701; CoMiCon, LUMINOUS-H2020-FETOPEN-2014-2015-RIA (686764), Bogenhausen Staedtische Klinik, Munich. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The medical procedure was approved by the Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM, The German Federal Institute for Drugs and Medical Devices). The study was declared as a Single Case Study and has received a special authorization (Sonderzulassung) by BfArM, according to 11 of the German Medical Device Law (Medizin-Produkte-Gesetz) on December 20, 2018, with Case Nr. 5640-S-036/18. The Ethical Committee of the Medical Faculty of the Technische Universitaet Muenchen Rechts der Isar provided support to the study on 19 Jan 2019, along with the explicit permission to publish on 17 February 2020. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Firing rate data recorded in this period as well as log files are available upon request and freely after peer-reviewed publication.