The Development and Clinical Application of a Miniature Transcranial Direct Current Stimulator in Rehabilitation Therapy (II)

Transcranial direct current stimulation (tDCS) is contemporarily important issues in the advanced rehabilitation medicine. tDCS can selectively change the excitability of regional cortex with non-invansive and safety properties. Some studies reported the motor re-learning effect of upper extremities in stroke patients by applying tDCS. However, the study regarding the optimal tDCS model for the rehabilitation of lower extremities is still rare. Therefore, the aim of this study is to develop a set of tDCS system for using in clinical rehabilitation of lower extremities. We hope the tDCS combined with the rehabilitation of lower extremities can shorten the duration of rehabilitative periods, improve patients’ activity of daily living, reduce the care burden of patients’ family, and subsequently decrease the cost of health care insurance. In the original version of our research plan, we arranged a three-year project. In first year, we will manufacture a set of tDCS system, and apply intellect patent for the system. In the second year, the developed device will be test in animal experiment for examinations of the biological safety and electrical damage, as well as the electrical performance of the device will be verified in an authorized institute. In addition, the optimal parameter of tDCS will be established in animal experiments. In the final year, on the basis of the results from animal experiments, we will run clinic trials with our developed t-DCS device in Taipei Medical University Hospital. Our team is currently implementing the first year plan, which is in the case that the whole project is dramatically ahead of the schedule. We have established the ISO13485 file system, developed a prototype tDCS system and signed contacts with National Applied Research Laboratories (NARL) and Electronics Testing Center (ETC) for manufacturing a tDCS system (close to premarket product specifications) and applying safety certification (safety certification was required to be done in the second year of the original plan). In addition, our laboratory prototype system has been used in animal experiments to verify the effectiveness and safety (the matters should be done in second year of the original plan). In addition, we have submitted Taiwan and U.S. patent applications to Dept. R & D at Taipei Medical University. Overall, we have reached all first-year KPI contents, also accomplished some KPI targets in the second year (including, safety certification, animal experiments, etc.). Therefore, it is expected that this project could be done within 2 years (i.e. only more year apply for the current project). An extension of the first year study, our second-year study will focus on (1) the animal experiments and (2) clinical human trials, to verify to verify the effectiveness and safety of our developed tDCS system. According to the results of animal and human experiments, (3) the second run of software and hardware verifications will be also conducted at the end of the second year. Although only a small scale of clinic trial runs in the two-year project, our ultimate goal is to get the FDA, CE, and TFDA permission for the usage of t-DCS in clinical rehabilitation. Therefore, after the two-year project, we will continue to organize a large scale of clinical trials to meet the standard of FDA , CE, and TFDA approval. Hope this t-DCS device would be commercially available in medical market, and extensively used in stroke patient to improve brain neural plasticity. In this way, it can improve the rehabilitation effect, reduce the duration of rehabilitation, and decrease medical cost in stroke patients