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In paediatric DOC, there is a critical need to develop evidence-based interventions to promote recovery of basic responses to improve rehabilitation and aid decision-making for medical teams and caregivers. The purpose of this investigation is to examine the safety, tolerability and feasibility of transcranial direct current stimulation (tDCS) in children with DOC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>This study is an open-label dose escalation trial evaluating the safety, tolerability and feasibility of tDCS in 10 children (5\u201317 years) receiving inpatient rehabilitation for DOC. This study will follow a modified rule-based design, allowing for intrapatient escalation, where a cohort of patients will be assigned to an initial tDCS current of 0.5 or 1 mA based on participant\u2019s head circumference and according to the safety data available in other paediatric populations. The subsequent assignment of increased current (1 or 2 mA) according to the prespecified rules will be based on the clinical observation of adverse events in the patients. The study will include up to three, 20\u2009min sessions of anodal tDCS (sham, 0.5 or 1 mA, 1 or 2 mA) applied over the dorsolateral prefrontal cortex. The primary outcomes are adverse events, pain associated with tDCS and intolerable disruption of inpatient care. Secondary outcomes are changes in electroencephalography (EEG) phase-locking and event-related potential components and the Coma Recovery Scale-Revised total score from prestimulation to poststimulation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>The Johns Hopkins IRB (#IRB00174966) approved this study. Trial results will be disseminated through journals and conferences.<\/jats:p><\/jats:sec><jats:sec><jats:title>Registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03618849\">NCT03618849<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2019-029967","type":"journal-article","created":{"date-parts":[[2019,8,10]],"date-time":"2019-08-10T17:09:27Z","timestamp":1565456967000},"page":"e029967","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":12,"title":["Single-arm, open-label, dose escalation phase I study to evaluate the safety and feasibility of transcranial direct current stimulation with electroencephalography biomarkers in paediatric disorders of consciousness: a study protocol"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03618849","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Ghazala T","family":"Saleem","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua Benjamin","family":"Ewen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jewel E","family":"Crasta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beth S","family":"Slomine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriela Lucila","family":"Cantarero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stacy J","family":"Suskauer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,8,10]]},"reference":[{"key":"2024052014001021000_9.8.e029967.1","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1007\/s40141-019-0214-4","article-title":"Rehabilitation in children with disorder of consciousness","volume":"7","author":"Yeh","year":"2019","journal-title":"Curr Phys Med Rehabil Rep"},{"key":"2024052014001021000_9.8.e029967.2","doi-asserted-by":"crossref","first-page":"1699","DOI":"10.1016\/j.apmr.2018.07.001","article-title":"Practice guideline update recommendations summary: disorders of consciousness: report of the Guideline development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; 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