Clinical usability study of a home-based self-administration transcranial direct current stimulation for primary dysmenorrhea: A randomized controlled trial.

Autor: Rodrigues YT; Graduate Program in Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil., Silva TCLA; Graduate Program in Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil., Radytė E; Samphire Neuroscience Ltd, London, United Kingdom., Bernatavičius E; Samphire Neuroscience Ltd, London, United Kingdom., Cook AA; Samphire Neuroscience Ltd, London, United Kingdom., Carvalho MLAS; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil., Macedo LES; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil., Oliveira JMP; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil., Martins TD; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil., Fonseca ME; Graduate Program in Health Science, Federal University of Rio Grande do Norte, Natal, Brazil., Micussi MTABC; Graduate Program in Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil., Pegado R; Graduate Program in Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.; Graduate Program in Health Science, Federal University of Rio Grande do Norte, Natal, Brazil.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2024 May 02; Vol. 19 (5), pp. e0301851. Date of Electronic Publication: 2024 May 02 (Print Publication: 2024).
DOI: 10.1371/journal.pone.0301851
Abstrakt: This study tested the usability of a home-based self-administration transcranial direct current stimulation (tDCS) device designed specifically for women's health needs. This is a single center triple blinded clinical usability study for a new wireless, Bluetooth-controlled wearable tDCS device for women's health. The study aims to evaluate the usability and effective blinding of a home-based tDCS system. A total of forty-nine women of reproductive age were randomly allocated (1:1) to receive one session of active tDCS (n = 24) or sham tDCS (n = 25) over the motor and dorsolateral prefrontal cortex. Each participant self-administered one 20-minute session without supervision following guidance on a software application alone. The System Usability Scale (SUS) and the Patient Global Impression of Change (PGIC) were used to evaluate the usability of the system. Regardless of sham or active conditions, all users found the system easy to use without the support of researchers. Usability scores were considered to be "excellent" in both groups and no significant difference was found between sham and active groups showing effective blinding of the device (Active group: 93.7 (83.1-97.5); Sham group 90 (86.2-95) p = 0.79) and PGIC (Active group: 2 (1-2.75); Sham group 2 (1-2) p = 0.99) using an unpaired t-test or non-parametric statistical tests accordingly. The new Bluetooth-controlled wearable tDCS device is easy, safe to use and completely controlled by a smartphone app. This device is focused on women's health and will be tested as an alternative treatment for chronic pelvic pain and mood disturbance associated with menstrual cycles in further research.
Competing Interests: Emilė Radytė, Alexander Anthony Cook and Ervinas Bernatavičius are employees and own shares in Samphire Neuroscience Ltd. Samphire Neuroscience Ltd contributed to the trial design, technical feasibility, questionnaire selection and data interpretation but did not participate in data collection or analysis. Other authors declare no conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2024 Rodrigues et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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