{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T21:29:44Z","timestamp":1775597384874,"version":"3.50.1"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,2,10]],"date-time":"2023-02-10T00:00:00Z","timestamp":1675987200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,2,10]],"date-time":"2023-02-10T00:00:00Z","timestamp":1675987200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["npj Digit. Med."],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered on <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> for four chronic neurological disorders: epilepsy, multiple sclerosis, Alzheimer\u2019s, and Parkinson\u2019s disease. We document growth in the collection of both more established digital measures (e.g., motor function) and more novel digital measures (e.g., speech) over recent years, highlighting contexts of use and key trends.<\/jats:p>","DOI":"10.1038\/s41746-023-00767-1","type":"journal-article","created":{"date-parts":[[2023,2,10]],"date-time":"2023-02-10T05:45:16Z","timestamp":1676007916000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":85,"title":["Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials"],"prefix":"10.1038","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2496-1415","authenticated-orcid":false,"given":"Lars","family":"Masanneck","sequence":"first","affiliation":[]},{"given":"Pauline","family":"Gieseler","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6975-3225","authenticated-orcid":false,"given":"William J.","family":"Gordon","sequence":"additional","affiliation":[]},{"given":"Sven G.","family":"Meuth","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3586-1041","authenticated-orcid":false,"given":"Ariel D.","family":"Stern","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2023,2,10]]},"reference":[{"key":"767_CR1","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1016\/S1474-4422(19)30411-9","volume":"19","author":"VL Feigin","year":"2020","unstructured":"Feigin, V. L. et al. The global burden of neurological disorders: translating evidence into policy. Lancet Neurol. 19, 255\u2013265 (2020).","journal-title":"Lancet Neurol."},{"key":"767_CR2","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1002\/ana.24897","volume":"81","author":"CL Gooch","year":"2017","unstructured":"Gooch, C. L., Pracht, E. & Borenstein, A. R. The burden of neurological disease in the United States: A summary report and call to action. Ann. Neurol. 81, 479\u2013484 (2017).","journal-title":"Ann. Neurol."},{"key":"767_CR3","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1111\/j.1468-1331.2011.03590.x","volume":"19","author":"J Olesen","year":"2012","unstructured":"Olesen, J. et al. The economic cost of brain disorders in Europe. Eur. J. Neurol. 19, 155\u2013162 (2012).","journal-title":"Eur. J. Neurol."},{"key":"767_CR4","doi-asserted-by":"publisher","first-page":"e1347","DOI":"10.1212\/WNL.0000000000005295","volume":"90","author":"DA Hall","year":"2018","unstructured":"Hall, D. A. et al. The state of clinical research in neurology. Neurology 90, e1347\u2013e1354 (2018).","journal-title":"Neurology"},{"key":"767_CR5","doi-asserted-by":"publisher","first-page":"844","DOI":"10.1001\/jama.2020.1166","volume":"323","author":"OJ Wouters","year":"2020","unstructured":"Wouters, O. J., McKee, M. & Luyten, J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA 323, 844\u2013853 (2020).","journal-title":"JAMA"},{"key":"767_CR6","doi-asserted-by":"publisher","first-page":"1446","DOI":"10.1111\/ene.14763","volume":"28","author":"L Lohmann","year":"2021","unstructured":"Lohmann, L. et al. Status of clinical research in neurology in Germany-A national survey. Eur. J. Neurol. 28, 1446\u20131452 (2021).","journal-title":"Eur. J. Neurol."},{"key":"767_CR7","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-019-1476-5","volume":"18","author":"N Naidoo","year":"2020","unstructured":"Naidoo, N. et al. The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Med. 18, 6 (2020).","journal-title":"BMC Med"},{"key":"767_CR8","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41746-019-0123-z","volume":"2","author":"C Stroud","year":"2019","unstructured":"Stroud, C., Onnela, J.-P. & Manji, H. Harnessing digital technology to predict, diagnose, monitor, and develop treatments for brain disorders. npj Digit. Med. 2, 1\u20134 (2019).","journal-title":"npj Digit. Med."},{"key":"767_CR9","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41746-020-0259-x","volume":"3","author":"C Marra","year":"2020","unstructured":"Marra, C., Chen, J. L., Coravos, A. & Stern, A. D. Quantifying the use of connected digital products in clinical research. npj Digit. Med. 3, 1\u20135 (2020).","journal-title":"npj Digit. Med."},{"key":"767_CR10","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41746-022-00583-z","volume":"5","author":"S Vasudevan","year":"2022","unstructured":"Vasudevan, S., Saha, A., Tarver, M. E. & Patel, B. Digital biomarkers: Convergence of digital health technologies and biomarkers. npj Digit. Med. 5, 1\u20133 (2022).","journal-title":"npj Digit. Med."},{"key":"767_CR11","unstructured":"Center for Drug Evaluation and Research. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. U.S. Food and Drug Administration https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/digital-health-technologies-remote-data-acquisition-clinical-investigations (2022). (accessed June 10, 2022)"},{"key":"767_CR12","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1038\/s41746-022-00607-8","volume":"5","author":"M Burq","year":"2022","unstructured":"Burq, M. et al. Virtual exam for Parkinson\u2019s disease enables frequent and reliable remote measurements of motor function. npj Digit. Med. 5, 65 (2022).","journal-title":"npj Digit. Med."},{"key":"767_CR13","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41746-019-0217-7","volume":"3","author":"N Mahadevan","year":"2020","unstructured":"Mahadevan, N. et al. Development of digital biomarkers for resting tremor and bradykinesia using a wrist-worn wearable device. npj Digit. Med. 3, 1\u201312 (2020).","journal-title":"npj Digit. Med."},{"key":"767_CR14","doi-asserted-by":"publisher","first-page":"e0138095","DOI":"10.1371\/journal.pone.0138095","volume":"10","author":"HH Dodge","year":"2015","unstructured":"Dodge, H. H. et al. Use of High-Frequency In-Home Monitoring Data May Reduce Sample Sizes Needed in Clinical Trials. PLOS ONE 10, e0138095 (2015).","journal-title":"PLOS ONE"},{"key":"767_CR15","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1038\/s41746-020-00334-y","volume":"3","author":"MD Czech","year":"2020","unstructured":"Czech, M. D. et al. Age and environment-related differences in gait in healthy adults using wearables. npj Digit. Med. 3, 127 (2020).","journal-title":"npj Digit. Med."},{"key":"767_CR16","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41746-021-00473-w","volume":"4","author":"W De Brouwer","year":"2021","unstructured":"De Brouwer, W., Patel, C. J., Manrai, A. K., Rodriguez-Chavez, I. R. & Shah, N. R. Empowering clinical research in a decentralized world. npj Digit. Med. 4, 1\u20135 (2021).","journal-title":"npj Digit. Med."},{"key":"767_CR17","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41746-019-0206-x","volume":"3","author":"SP Rowland","year":"2020","unstructured":"Rowland, S. P., Fitzgerald, J. E., Holme, T., Powell, J. & McGregor, A. What is the clinical value of mHealth for patients? npj Digit. Med. 3, 1\u20136 (2020).","journal-title":"npj Digit. Med."},{"key":"767_CR18","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41746-021-00470-z","volume":"4","author":"IB Meier","year":"2021","unstructured":"Meier, I. B. et al. Using a Digital Neuro Signature to measure longitudinal individual-level change in Alzheimer\u2019s disease: the Altoida large cohort study. npj Digit. Med. 4, 1\u20139 (2021).","journal-title":"npj Digit. Med."},{"key":"767_CR19","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41746-019-0084-2","volume":"2","author":"LC Kourtis","year":"2019","unstructured":"Kourtis, L. C., Regele, O. B., Wright, J. M. & Jones, G. B. Digital biomarkers for Alzheimer\u2019s disease: the mobile\/wearable devices opportunity. npj Digit. Med. 2, 1\u20139 (2019).","journal-title":"npj Digit. Med."},{"key":"767_CR20","unstructured":"Beats Medical. A Randomized, Cross-Over, Placebo-Controlled Pilot Study to Evaluate the Self-Management of Gait, Speech and Dexterity in Patients With Parkinson\u2019s Disease Using a Novel Digital Therapeutic Approach. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05120609 (2021)."},{"key":"767_CR21","unstructured":"Goalspal LLC. A Study to Analyze Features of Dysphonia and Tremor in PD Patients to Aid in the Development of an Accurate Diagnostic Tool for Early-Detection of PD. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04288804 (2022)."},{"key":"767_CR22","unstructured":"University Hospital, Lille. A Prospective Study on Markers of Disease Progression and Gait Within the Parkinsonian Population. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04653688 (2022)."},{"key":"767_CR23","unstructured":"Xu, S. (Steve). Novel Sensor for Swallowing in Patients With Parkinson\u2019s Disease. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04664634 (2022)."},{"key":"767_CR24","doi-asserted-by":"publisher","first-page":"654","DOI":"10.1177\/13524585211028561","volume":"28","author":"X Montalban","year":"2022","unstructured":"Montalban, X. et al. A smartphone sensor-based digital outcome assessment of multiple sclerosis. Mult. Scler. J. 28, 654\u2013664 (2022).","journal-title":"Mult. Scler. J."},{"key":"767_CR25","doi-asserted-by":"publisher","first-page":"e14863","DOI":"10.2196\/14863","volume":"21","author":"L Midaglia","year":"2019","unstructured":"Midaglia, L. et al. Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study. J. Med. Internet Res. 21, e14863 (2019).","journal-title":"J. Med. Internet Res."},{"key":"767_CR26","doi-asserted-by":"publisher","first-page":"e31972","DOI":"10.2196\/31972","volume":"6","author":"V Limmroth","year":"2022","unstructured":"Limmroth, V., Bayer-Gersmann, K., Mueller, C. & Sch\u00fcrks, M. Ascertaining Medication Use and Patient-Reported Outcomes via an App and Exploring Gamification in Patients With Multiple Sclerosis Treated With Interferon \u03b2-1b: Observational Study. JMIR Form. Res. 6, e31972 (2022).","journal-title":"JMIR Form. Res."},{"key":"767_CR27","unstructured":"Stichting Epilepsie Instellingen Nederland. Using Day-to-day Behavior on Smartphones to Improve Epilepsy Management. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04617418 (2021)."},{"key":"767_CR28","unstructured":"Dawson, W. Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology: Living and Learning With Advancing AD. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04335110 (2022)."},{"key":"767_CR29","unstructured":"Rose, K. Collaborative Research: Learning and Improving Alzheimer\u2019s Patient-Caregiver Relationships Via Smart Healthcare Technology. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04536701 (2021)."},{"key":"767_CR30","doi-asserted-by":"publisher","first-page":"e37614","DOI":"10.2196\/37614","volume":"24","author":"K-H Lam","year":"2022","unstructured":"Lam, K.-H. et al. The Use of Smartphone Keystroke Dynamics to Passively Monitor Upper Limb and Cognitive Function in Multiple Sclerosis: Longitudinal Analysis. J. Med. Internet Res. 24, e37614 (2022).","journal-title":"J. Med. Internet Res."},{"key":"767_CR31","unstructured":"Altoida. Precision Medicine Initiative Against Alzheimer\u2019s Disease (PMIAAD): Digitally-enhanced, Decentralized, Multi-omics, Observational Cohort. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04701177 (2022)."},{"key":"767_CR32","unstructured":"Novoic Limited. A Study to Evaluate the Ability of Speech- and Language-based Digital Biomarkers to Detect and Characterise Prodromal and Preclinical Alzheimer\u2019s Disease in a Clinical Setting - FUTURE Extension Study. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04846426 (2021)."},{"key":"767_CR33","unstructured":"Washington University School of Medicine. Cerebrospinal Fluid-biomarkers-based Diagnostic and Prognostic Models for Multiple Sclerosis. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04496830 (2022)."},{"key":"767_CR34","doi-asserted-by":"publisher","first-page":"183","DOI":"10.1159\/000517411","volume":"5","author":"L Servais","year":"2021","unstructured":"Servais, L. et al. First Regulatory Qualification of a Novel Digital Endpoint in Duchenne Muscular Dystrophy: A Multi-Stakeholder Perspective on the Impact for Patients and for Drug Development in Neuromuscular Diseases. Digit. Biomark. 5, 183\u2013190 (2021).","journal-title":"Digit. Biomark."},{"key":"767_CR35","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1038\/s41746-020-0260-4","volume":"3","author":"JC Goldsack","year":"2020","unstructured":"Goldsack, J. C. et al. Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs). npj Digit. Med. 3, 55 (2020).","journal-title":"npj Digit. Med."},{"key":"767_CR36","unstructured":"Plotly Technologies Inc. Collaborative data science. (2015)."},{"key":"767_CR37","unstructured":"Esmukov, K. & others. geopy. (2022)."}],"container-title":["npj Digital Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41746-023-00767-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41746-023-00767-1","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41746-023-00767-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,13]],"date-time":"2023-02-13T16:15:52Z","timestamp":1676304952000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41746-023-00767-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,10]]},"references-count":37,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["767"],"URL":"https:\/\/doi.org\/10.1038\/s41746-023-00767-1","relation":{},"ISSN":["2398-6352"],"issn-type":[{"value":"2398-6352","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,10]]},"assertion":[{"value":"5 August 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 January 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 February 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"LM reports personal fees from Biogen and Merck, both outside the scope of this study, PG reports personal fees for activities as a patient consultant from Novartis, WJG reports consulting income from Novocardia Inc., and Great Point Ventures, outside the scope of this work, SGM reports no conflict of interest related to this study, ADS declares that she serves as a member of the Scientific Advisory Board of the German Society for Digital Medicine and the Strategic Advisory Board of HumanFirst.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"23"}}