Abstract
Study design
A randomized, sham-controlled clinical trial.
Objective
To test the effects of tDCS, combined with robotic training, on gait disability in SCI. Our hypothesis was that participants who received active tDCS would experience greater walking gains, as indexed by the WISCI-II, than those who received sham tDCS.
Setting
University of São Paulo, Brazil.
Methods
This randomized, double-blind study comprised 43 participants with incomplete SCI who underwent 30 sessions of active (n = 21) or sham (n = 22) tDCS (20 min, 2 mA) before every Lokomat session of 30 min (3 times a week over 12 weeks or 5 times a week over 6 weeks). The main outcome was the improvement in WISCI-II. Participants were assessed at baseline, after 15 and 30 sessions of Lokomat, and after three months of treatment.
Results
There was a significant difference in the percentage of participants that improved in WISCI-II at the 30-session, compared with baseline: 33.3% in the sham group and 70.0% in the active group (p = 0.046; OR: 3.7; 95% CI: 1.0–13.5). At the follow-up, the improvement compared with baseline in the sham group was 35.0% vs. 68.4% for the active group (p = 0.046; OR: 3.7; 95% CI: 1.0–13.5). There was no significant difference at the 15-session.
Conclusion
Thirty sessions of active tDCS is associated with a significant improvement in walking, compared to sham. Moreover, 15 sessions had no significant effect. The improvement in WISCI-II can be related to different aspects of motor learning, including motor recovery and compensation.
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Acknowledgements
Authors are grateful to Margarida H. Miyazaki, executive director of IMREA and Katia Lina Miyahara, Clinical Director of IMREA, for the great support of the hospital. Besides, Artur dos Santos, Antonio Migliorati, Daniel de Souza, Denise Matheus, Gerson Barbieri Filho, Karin Santos, Mariana Milazzotto, Patricia Monteiro Marchiore, Thais Terranova, Tharsila de Oliveira and Vivian da Silva for assistance with participant data collection and study monitoring.
Funding
This work was supported by grants from Ministry of Health (SIPAR: 25000.160.761/2014-54). The researchers received support from the São Paulo Research Foundation (FAPESP- SPEC, grant #2017/12943-8). The work received a support from Núcleo de Apoio a Pesquisa-Núcleo de Estudos Avançados em Reabilitação (NAP-NEAR).
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MS, FF, and LB conceptualized the paper. MS and LB applied the therapies. MS and FF analyzed the data. LCB and FF provided a critical review.
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We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research. This study was approved by the Ethics Committee for Analysis of Research Projects of the University of São Paulo Medical School.
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Simis, M., Fregni, F. & Battistella, L.R. Transcranial direct current stimulation combined with robotic training in incomplete spinal cord injury: a randomized, sham-controlled clinical trial. Spinal Cord Ser Cases 7, 87 (2021). https://doi.org/10.1038/s41394-021-00448-9
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DOI: https://doi.org/10.1038/s41394-021-00448-9
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