Data for: "Brain activity and upper limb movement analysis in children with Down syndrome undergoing transcranial direct current stimulation combined with virtual reality training: study protocol for a randomized controlled trial"

  • Jamile Benite Palma Lopes (Creator)
  • I. Miziara (Creator)
  • Danial Kahani (Creator)
  • Rodolfo Borges Parreira (Creator)
  • Natalia de Almeida Carvalho Duarte (Creator)
  • R. Lazzari (Creator)
  • Lucas Villalta Santos (Creator)
  • Carlos Bandeira de Mello Monteiro (Creator)
  • Deborah Carvalho da Silva Cardoso (Creator)
  • Juliana de Oliveira Hassel Mendes (Creator)
  • Vera Lucia dos Santos Alves (Creator)
  • Iransé Oliveira Silva (Creator)
  • Luis Vicente Oliveira (Creator)
  • Bernard A Conway (Creator)
  • Manuela Galli (Creator)
  • Veronica Cimolin (Creator)
  • Claudia Santos Oliveira (Creator)



Abstract Background Children with Down syndrome have poorer functional and sensory skills compared to children with typical development. Virtual reality (VR) training could help improve these skills. Moreover, transcranial direct current stimulation (tDCS) has achieved promising results in terms of enhancing the effects of physical and sensory therapy by modulating cortical excitability. Methods/design Two investigations are proposed: (1) an observational study with a convenience sample consisting of children with Down syndrome (group 1—cognitive age of 6 to 12 years according to the Wechsler Abbreviated Scale of Intelligence) and children with typical development 6 to 12 years of age (group 2). Both groups will undergo evaluations on a single day involving a three-dimensional analysis of upper limb movements, an analysis of muscle activity of the biceps and brachial triceps muscles and an analysis of visuospatial and cognitive-motor variables. (2) Analysis of clinical intervention: a pilot study and clinical trial will be conducted involving individuals with Down syndrome (cognitive age of 6 to 12 years according to the Wechsler Abbreviated Scale of Intelligence). The sample will be defined after conducting a pilot study with the same methodology as that to be used in the main study. The participants will be randomly allocated to two groups: An experimental group submitted to anodal tDCS combined with a VR game and a manual motor task and a control group submitted to sham tDCS combined with a VR game and a manual motor task. The training protocol will involve 10 sessions of active or sham tDCS during memory and motor task games. Three 20-min sessions will be held per week for a total of 10 sessions. Evaluations will be performed on three different occasions: pre-intervention, post-intervention (after 10 sessions) and follow-up (1 month after the intervention). Evaluations will consist of analyses of electroencephalographic signals, electromyographic signals of the biceps and triceps brachii, and the three-dimensional reconstruction of the reaching movement. The results will be analyzed statistically with the significance level set at 5% (p ≤ 0.05). Discussion The optimization of the results obtained with virtual reality training is believed to be related to the interactive experience with a wide range of activities and scenarios involving multiple sensory channels and the creation of exercises, the intensity of which can be adjusted to the needs of children. Therefore, the proposed study aims to complement the literature with further information on tDCS and VR training considering different variables to provide the scientific community with clinical data on this combination of interventions. Trial registration Brazilian Clinical Trials Registry (REBEC) protocol number RBR-43pk59 registered on 2019 March 27 and Human Research Ethics Committee number 3.608.521 approved on 2019 September 30. Protocol version 2021 October 20. Any changes to the protocol will be reported to the committees and approved. Informed consent will be obtained from all participants by the clinical research coordinator and principal investigator.

Dataset includes:

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Additional file 2. Appendix A: Consent form for participation in clinical research. 10.6084/m9.figshare.19090671.v1

Additional file 3. Appendix B: Minor consent form. 10.6084/m9.figshare.19090674.v1

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Date made available6 Feb 2023
Date of data production2022

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