Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial
<b>Background/Objectives:</b> Chronic attention problems occur in approximately 25% of children after acquired brain injury (ABI). When delivered daily, transcranial direct current stimulation (tDCS) may improve attention; however, access to daily in-clinic tDCS treatment can be limited...
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2025-05-01
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| author | Athena Stein Justin Riddle Kevin A. Caulfield Paul E. Dux Maximilian A. Friehs Philipp A. Schroeder Michael P. Craven Madeleine J. Groom Kartik K. Iyer Karen M. Barlow |
| author_facet | Athena Stein Justin Riddle Kevin A. Caulfield Paul E. Dux Maximilian A. Friehs Philipp A. Schroeder Michael P. Craven Madeleine J. Groom Kartik K. Iyer Karen M. Barlow |
| author_sort | Athena Stein |
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| description | <b>Background/Objectives:</b> Chronic attention problems occur in approximately 25% of children after acquired brain injury (ABI). When delivered daily, transcranial direct current stimulation (tDCS) may improve attention; however, access to daily in-clinic tDCS treatment can be limited by other commitments, including concurrent therapy, school commitments, and caregiver schedules. Treatment access can be improved through home-based interventions, though these require several practical and safety considerations in a pediatric ABI population. This study evaluated the safety, feasibility, and tolerability of remotely monitored at-home tDCS during online gamified attention training in pediatric ABI. <b>Methods</b>: We conducted a randomized, single-blind, dose-controlled clinical trial of at home tDCS in Brisbane, Australia (10 tDCS sessions; 20 min; 1 mA or 2 mA; bilateral dorsolateral prefrontal cortex). Participants attended our clinic at baseline for clinical assessments, fitting of the personalized tDCS headband, and training in how to use tDCS at home. All sessions were remotely supervised using live videoconferencing. We assessed the feasibility and tolerability of at-home tDCS and our customized, personalized at-home tDCS headband as primary outcomes. As secondary outcomes, we evaluated changes in functional connectivity (fc) and reaction time (RT). <b>Results:</b> Seventy-three participants were contacted over six months (January-June 2023) and ten were enrolled (5 males; mean age: 12.10 y [SD: 2.9]), satisfying a priori recruitment timelines (CONSORT reporting). All families successfully set up tDCS and completed attention training with excellent protocol adherence. There were no serious adverse events over the 100 total sessions. Nine participants completed all stimulation sessions (1 mA: <i>n</i> = 5, 2 mA: <i>n</i> = 4). Participants in the 2 mA group reported greater tingling, itching, and discomfort (all <i>p</i> < 0.05). One participant in the 1 mA group was unable to complete all sessions due to tolerability challenges; however, these challenges were resolved in the second half of the intervention by gradually increasing the stimulation duration across the 10 days alongside additional coaching and support. <b>Conclusions</b>: Overall, daily remotely supervised at-home tDCS in patients with pediatric ABI is safe, feasible, and tolerable. Our results support larger, sham-controlled efficacy trials and provide a foundation for the development of safe and effective at-home stimulation therapeutics that may offer targeted improvement of neurocognitive symptoms in children. |
| format | Article |
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| institution | Kabale University |
| issn | 2076-3425 |
| language | English |
| publishDate | 2025-05-01 |
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| spelling | doaj-art-b62f895b703a4c2fbff85675afe735c12025-08-20T03:27:17ZengMDPI AGBrain Sciences2076-34252025-05-0115656110.3390/brainsci15060561Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot TrialAthena Stein0Justin Riddle1Kevin A. Caulfield2Paul E. Dux3Maximilian A. Friehs4Philipp A. Schroeder5Michael P. Craven6Madeleine J. Groom7Kartik K. Iyer8Karen M. Barlow9Acquired Brain Injury in Children Research Program, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, QLD 4101, AustraliaDepartment of Psychology, Florida State University, Tallahassee, FL 32306, USABrain Stimulation Division, Medical University of South Carolina, Charleston, SC 29425, USASchool of Psychology, The University of Queensland, Brisbane, QLD 4072, AustraliaPsychology of Conflict Risk and Safety, University of Twente, 7500 AE Enschede, The NetherlandsDepartment of Psychology, University of Tübingen, 72076 Tübingen, GermanyNIHR MindTech MedTech Co-Operative, Institute of Mental Health, University of Nottingham, Nottingham NG7 2TU, UKNIHR MindTech MedTech Co-Operative, Institute of Mental Health, University of Nottingham, Nottingham NG7 2TU, UKAcquired Brain Injury in Children Research Program, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, QLD 4101, AustraliaAcquired Brain Injury in Children Research Program, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, QLD 4101, Australia<b>Background/Objectives:</b> Chronic attention problems occur in approximately 25% of children after acquired brain injury (ABI). When delivered daily, transcranial direct current stimulation (tDCS) may improve attention; however, access to daily in-clinic tDCS treatment can be limited by other commitments, including concurrent therapy, school commitments, and caregiver schedules. Treatment access can be improved through home-based interventions, though these require several practical and safety considerations in a pediatric ABI population. This study evaluated the safety, feasibility, and tolerability of remotely monitored at-home tDCS during online gamified attention training in pediatric ABI. <b>Methods</b>: We conducted a randomized, single-blind, dose-controlled clinical trial of at home tDCS in Brisbane, Australia (10 tDCS sessions; 20 min; 1 mA or 2 mA; bilateral dorsolateral prefrontal cortex). Participants attended our clinic at baseline for clinical assessments, fitting of the personalized tDCS headband, and training in how to use tDCS at home. All sessions were remotely supervised using live videoconferencing. We assessed the feasibility and tolerability of at-home tDCS and our customized, personalized at-home tDCS headband as primary outcomes. As secondary outcomes, we evaluated changes in functional connectivity (fc) and reaction time (RT). <b>Results:</b> Seventy-three participants were contacted over six months (January-June 2023) and ten were enrolled (5 males; mean age: 12.10 y [SD: 2.9]), satisfying a priori recruitment timelines (CONSORT reporting). All families successfully set up tDCS and completed attention training with excellent protocol adherence. There were no serious adverse events over the 100 total sessions. Nine participants completed all stimulation sessions (1 mA: <i>n</i> = 5, 2 mA: <i>n</i> = 4). Participants in the 2 mA group reported greater tingling, itching, and discomfort (all <i>p</i> < 0.05). One participant in the 1 mA group was unable to complete all sessions due to tolerability challenges; however, these challenges were resolved in the second half of the intervention by gradually increasing the stimulation duration across the 10 days alongside additional coaching and support. <b>Conclusions</b>: Overall, daily remotely supervised at-home tDCS in patients with pediatric ABI is safe, feasible, and tolerable. Our results support larger, sham-controlled efficacy trials and provide a foundation for the development of safe and effective at-home stimulation therapeutics that may offer targeted improvement of neurocognitive symptoms in children.https://www.mdpi.com/2076-3425/15/6/561neuromodulationTBIpediatricconnectivityHD-EEGtDCS |
| spellingShingle | Athena Stein Justin Riddle Kevin A. Caulfield Paul E. Dux Maximilian A. Friehs Philipp A. Schroeder Michael P. Craven Madeleine J. Groom Kartik K. Iyer Karen M. Barlow Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial Brain Sciences neuromodulation TBI pediatric connectivity HD-EEG tDCS |
| title | Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial |
| title_full | Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial |
| title_fullStr | Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial |
| title_full_unstemmed | Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial |
| title_short | Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial |
| title_sort | safety feasibility and tolerability of ten days of at home remotely supervised tdcs during gamified attention training in children with acquired brain injury an open label dose controlled pilot trial |
| topic | neuromodulation TBI pediatric connectivity HD-EEG tDCS |
| url | https://www.mdpi.com/2076-3425/15/6/561 |
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