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

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.

Transcranial Direct Current Stimulation Associated With Functional Exercise Program for Treating Fibromyalgia: A Randomized Controlled Trial.

OBJECTIVE: To investigate the effects of transcranial direct current stimulation (tDCS) associated with functional exercise on pain, functional performance, psychological symptoms, and quality of life of patients with fibromyalgia (FM). DESIGN: Randomized controlled trial. Participants were randomized by blocks into 2 groups: tDCS associated with functional exercise (n=17) and sham-tDCS associated with functional exercise (n=14). SETTING: Laboratory of neuromuscular performance in the department of physical therapy. PARTICIPANTS: Women with FM (N=31) according to American College of Rheumatology-2010 criteria. INTERVENTIONS: Anodal tDCS or sham-tDCS was applied over the left motor cortex for 5 consecutive days during the first week of intervention (2 mA; 20min). All volunteers also engaged in 8 weeks of functional exercises 3 times per week. MAIN OUTCOME MEASURES: Pain intensity, functional performance, psychological symptoms, and quality of life were assessed pre-exercise and immediately after the first, fourth, and eighth weeks of intervention. RESULTS: Pain intensity, functional performance, psychological symptoms, and quality of life increased significantly in both groups (P<.05); however, no significant differences between groups were found in all outcomes (P>.05). CONCLUSION: tDCS associated with functional exercises did not enhance the effects of physical exercise on pain, functional performance, psychological symptoms, and quality of life of patients with FM.