NDLI: Remotely monitored transcranial direct current stimulation in pediatric cerebral palsy: open label trial protocol

Content Provider	Springer Nature : BioMed Central
Author	Simpson, Emma A. Saiote, Catarina Sutter, Ellen Lench, Daniel H. Ikonomidou, Chrysanthy Villegas, Melissa A. Gillick, Bernadette T.
Abstract	Background Pediatric applications of non-invasive brain stimulation using transcranial direct current stimulation (tDCS) have demonstrated its safety with few adverse events reported. Remotely monitored tDCS, as an adjuvant intervention to rehabilitation, may improve quality of life for children with cerebral palsy (CP) through motor function improvements, reduced treatment costs, and increased access to tDCS therapies. Our group previously evaluated the feasibility of a remotely monitored mock tDCS setup in which families and children successfully demonstrated the ability to follow tDCS instructional guidance. Methods and design Here, we designed a protocol to investigate the feasibility, safety, and tolerability of at-home active transcranial direct current stimulation in children with CP with synchronous supervision from laboratory investigators. Ten participants will be recruited to participate in the study for 5 consecutive days with the following sessions: tDCS setup practice on day 1, sham tDCS on day 2, and active tDCS on days 3-5. Sham stimulation will consist of an initial 30-second ramp up to 1.5 mA stimulation followed by a 30-second ramp down. Active stimulation will be delivered at 1.0 - 1.5 mA for 20 minutes and adjusted based on child tolerance. Feasibility will be evaluated via photographs of montage setup and the quality of stimulation delivery. Safety and tolerability will be assessed through an adverse events survey, the Box and Blocks Test (BBT) motor assessment, and a setup ease/comfort survey. Discussion We expect synchronous supervision of at-home teleneuromodulation to be tolerable and safe with increasing stimulation quality over repeated sessions when following a tDCS setup previously determined to be feasible. The findings will provide opportunity for larger clinical trials exploring efficacy and illuminate the potential of remotely monitored tDCS in combination with rehabilitation interventions as a means of pediatric neurorehabilitation. This will demonstrate the value of greater accessibility of non-invasive brain stimulation interventions and ultimately offer the potential to improve care and quality of life for children and families with CP. Trial Registration October 8, 2021( https://clinicaltrials.gov/ct2/show/NCT05071586 )
Related Links	https://bmcpediatr.biomedcentral.com/counter/pdf/10.1186/s12887-022-03612-8.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	14712431
DOI	10.1186/s12887-022-03612-8
Journal	BMC Pediatrics
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2022-09-29
Access Restriction	Open
Subject Keyword	Pediatrics Internal Medicine Cerebral palsy Transcranial direct current stimulation (tDCS) Remotely supervised tDCS Non-invasive brain stimulation Children Motor function
Content Type	Text
Resource Type	Article
Subject	Pediatrics, Perinatology and Child Health
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.4/2023

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