Abstract
Transcranial Direct Current Stimulation (tDCS) has been the target of research in the search to understand its therapeutic effects on human health and the mechanisms by which these effects are mediated. The lack of standardization and the high cost of tDCS devices for clinical trials are some of the bottlenecks in the progress of tDCS research. The development of low-cost open-source devices, adaptable to research questions and that encourage innovation in the area are important. These devices can contribute to the understanding of tDCS mechanisms and effectiveness. Thus, this project presents a development of a tDCS prototype for clinical trials, consisting of hardware for electric stimulation, and a mobile app as a human–machine interface. The hardware is based on a direct current source and a microcontroller (ESP32), which communicates via Bluetooth® with the app. The mobile app was developed collaboratively with researchers. The built prototype had its performance evaluated through bench testing, showing a current production accuracy of 96.53%. It is expected that this project will facilitate access to tDCS devices to research groups that want to explore their effectiveness in most health conditions, following the methodological rigor of clinical trials.
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References
Nitsche MA, Paulus W (2000) Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol 633–639. https://doi.org/10.1111/j.1469-7793.2000.t01-1-00633.x
Priori A (2003) Brain polarization in humans: a reappraisal of an old tool for prolonged non-invasive modulation of brain excitability. Clin Neurophysiol 114(4):589–595. https://doi.org/10.1016/S1388-2457(02)00437-6
Bikson M, Inoue M, Akiyama H, Deans JK, Fox JE, Miyakawa H, Jefferys JGR (2004) Effect of uniform extracellular DC electric fields on excitability in rat hippocampal slices in vitro. J Physiol 557(1):175–190. https://doi.org/10.1113/jphysiol.2003.055772
Radman T, Su Y, Je HA, Parra LC, Bikson M (2007) Spike timing amplifies the effect of electric fields on neurons: implications for endogenous field effects. J Neurosci 27(11):3030–3036. https://doi.org/10.1523/JNEUROSCI.0095-07.2007
Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, Ridder D De, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W (2017) Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clinical Neurophysiol 128(1). https://doi.org/10.1016/j.clinph.2016.10.087
Chase HW, Boudewyn MA, Carter CS, Phillips ML (2020) Transcranial direct current stimulation: a roadmap for research, from mechanism of action to clinical implementation. Molecular Psyc 25(2):397–407. https://doi.org/10.1038/s41380-019-0499-9
Spieth PM, Kubasch AS, Isabel Penzlin A, Min-Woo Illigens B, Barlinn K, Siepmann T, Carl H, Carus G (2016) Randomized controlled trials—a matter of design. Neuropsychiatric Disease Treatment 12:1341–1349. https://doi.org/10.2147/NDT.S101938
Gandiga PC, Hummel FC, Cohen LG (2006) Transcranial DC stimulation (tDCS): A tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol 117(4):845–850. https://doi.org/10.1016/j.clinph.2005.12.003
Fonteneau C, Mondino M, Arns M, Baeken C, Bikson M, Brunoni AR, Burke MJ, Neuvonen T, Padberg F, Pascual-Leone A, Poulet E, Ruffini G, Santarnecchi E, Sauvaget A, Schellhorn K, Suaud-Chagny MF, Palm U, Brunelin J (2019) Sham tDCS: a hidden source of variability? Reflections for further blinded, controlled trials. Brain Stimulation 12(3):668–673. https://doi.org/10.1016/j.brs.2018.12.977
Alonzo A, Aaronson S, Bikson M, Husain M, Lisanby S, Martin D, McClintock SM, McDonald WM, O’Reardon J, Esmailpoor Z, Loo C (2016) Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression. Contemp Clinical Trials 51:65–71. https://doi.org/10.1016/j.cct.2016.10.002
Kouzani AZ, Jaberzadeh S, Zoghi M, Usma C, Parastarfeizabadi M (2016) Development and validation of a miniature programmable tDCS device. IEEE Trans Neural Syst Rehabil Eng 24(1):192–198. https://doi.org/10.1109/TNSRE.2015.2468579
Maier A, Sharp A, Vagapov Y (2017) Comparative analysis and practical implementation of the ESP32 microcontroller module for the internet of things. Internet Technol Appl (ITA), Wrexham 4(2):143–148. https://doi.org/10.1109/ITECHA.2017.8101926
Flutter. flutter.dev
DaSilva AF, Volz MS, Bikson M, Fregni F (2011) Electrode positioning and montage in transcranial direct current stimulation. J Visualized Experi (51). https://doi.org/10.3791/2744
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A (2008) Transcranial direct current stimulation: state of the art 2008. Brain Stimulation 1(3):206–223. https://doi.org/10.1016/j.brs.2008.06.004
Bikson M, Datta A, Elwassif M (2009) Establishing safety limits for transcranial direct current stimulation. Clin Neurophysiol 120(6):1033–1034. https://doi.org/10.1016/j.clinph.2009.03.018.Establishing
Dun K van, Bodranghien FCAA, Mariën P, Manto MU (2016) TDCS of the cerebellum: where do we stand in 2016? Technical issues and critical review of the literature. Front Hum Neurosci. https://doi.org/10.3389/fnhum.2016.00199
Palm U, Reisinger E, Keeser D, Kuo MF, Pogarell O, Leicht G, Mulert C, Nitsche MA, Padberg F (2013) Evaluation of sham transcranial direct current stimulation for randomized, placebo-controlled clinical trials. Brain Stimulation 6(4):690–695. https://doi.org/10.1016/j.brs.2013.01.005
Ezquerro F, Moffa AH, Bikson M, Khadka N, Aparicio LVM, de Sampaio-Junior B, Fregni F, Bensenor IM, Lotufo PA, Pereira AC, Brunoni AR (2017) The influence of skin redness on blinding in transcranial direct current stimulation studies: a crossover trial. Neuromodulation 20(3):248–255. https://doi.org/10.1111/ner.12527
Lefaucheur JP (2016) A comprehensive database of published tDCS clinical trials (2005–2016). Neurophysiologie Clinique 46(6). https://doi.org/10.1016/j.neucli.2016.10.002
Renjith V (2017) Blinding in randomized controlled trials: what researchers need to know ? Manipal J Nursing Health Sci 3(1):45–50
Niezen G, Eslambolchilar P, Thimbleby H (2016) Open-source hardware for medical devices. BMJ Innov 2(2):78–83. https://doi.org/10.1136/bmjinnov-2015-000080
White SR, Amarante LM, Kravitz A V., Laubach M (2019) The future is open: Open-source tools for behavioral neuroscience research. eNeuro 6(4):1–5. https://doi.org/10.1523/ENEURO.0223-19.2019
Cucca A, Sharma K, Agarwal S, Feigin AS, Biagioni MC (2019) Tele-monitored tDCS rehabilitation: feasibility, challenges and future perspectives in Parkinson’s disease 11 Medical and Health Sciences 1117 Public Health and Health Services 11 Medical and Health Sciences 1109 Neurosciences. J Neuro Eng Rehabilit 16(1):1–10. https://doi.org/10.1186/s12984-019-0481-4
Carvalho F, Brietzke AP, Gasparin A, Dos SFP, Vercelino R, Ballester RF, Sanches PRS, da Silva DP, Torres ILS, Fregni F, Caumo W (2018) Home-based transcranial direct current stimulation device development: an updated protocol used at home in healthy subjects and fibromyalgia patients. J Visualized Experi 137:1–9. https://doi.org/10.3791/57614
Hahn C, Rice J, Macuff S, Minhas P, Rahman A, Bikson M (2013) Methods for extra-low voltage transcranial direct current stimulation: Current and time dependent impedance decreases. Clin Neurophysiol 124(3):551–556. https://doi.org/10.1016/j.clinph.2012.07.028
Acknowledgements
The authors thank Coordenação de Aperfeiçoamento de Pessoal do Ensino Superior (CAPES) for the award of fellowships during the period of this work.
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The authors declares that there is no conflict of interest regarding the publication of this article.
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Teixeira-Neto, N.C., Azevedo-Cavalcanti, R.T., Monte-da-Silva, M.G.N., Da-Gama, A.E.F. (2022). Development of a Low-Cost, Open-Source Transcranial Direct-Current Stimulation Device (tDCS) for Clinical Trials. In: Bastos-Filho, T.F., de Oliveira Caldeira, E.M., Frizera-Neto, A. (eds) XXVII Brazilian Congress on Biomedical Engineering. CBEB 2020. IFMBE Proceedings, vol 83. Springer, Cham. https://doi.org/10.1007/978-3-030-70601-2_125
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