Usability of Home-Based, Self-Administered Transcranial Direct Current Stimulation for Women with Primary Dysmenorrhea: A Planned Clinical Trial
Usability Test, Pelvic Pain, Chronic Pain, Motor Cortex, Home Based, self-administered
Primary dysmenorrhea (PD) is a common condition that causes abdominal pain, malaise, fatigue and mood changes before and during menstruation. It significantly affects women’s functionality, work and quality of life, with drug treatments often having limited long-term results. The persistence of PD can lead to brain changes related to pain control. In recent years, neuromodulation therapies such as transcranial direct current stimulation (tDCS) have been suggested. Objective: This study evaluates the usability of a Bluetooth-controlled, self-administered home-based tDCS device with a focus on women's health. Methods: This is a double-blind, single-center clinical usability study conducted at the Federal University of Rio Grande do Norte (UFRN), Natal, Brazil. A total of forty-nine symptomatic women of reproductive age were randomly allocated (1:1) to receive either an active tDCS session (n = 24) or a sham tDCS session (n = 25) over the primary motor area and dorsolateral prefrontal cortex. Each participant self-administered a 20-minute session without supervision, following guidance only through a software application. The System Usability Scale (SUS) and the Patient Global Impression of Change (PGIC) were used to assess system usability. The clinical assessment of each participant was collected solely for sample characterization. Expected results: A positive usability assessment of the system may offer an alternative home treatment for chronic pelvic pain and mood disorders associated with menstrual cycles in future research.