Home-based transcranial electrical stimulation to scale clinical trials: methodology, safety, and beyond

Clinical trials of transcranial electrical stimulation (tES) are rapidly increasing in number as research explores potential therapeutic uses across a wide range of neurological and psychiatric conditions. Both human and mechanistic studies have shown that tES can have a cumulative benefit across multiple stimulation sessions, but this presents a practical challenge for investigators when participants are required to travel to a clinic or lab for daily treatment. The ability to deploy tDCS and other emerging TES at home is a key advantage in scaling clinical trials. Home-based tES delivery has the potential to increase participation and accommodate a larger number of tES sessions, which may be necessary for a thorough evaluation of its effects. However, there are several important factors to consider such as methodology, safety, and ethical aspects when conducting home-based tES clinical trials. This lecture will provide a comprehensive review of the methodology, instruments, and safety considerations surrounding the growing body of home-based tES trials. The discussion will also include the current regulatory landscape surrounding the home use of tES devices, addressing some of the concerns such as the lack of oversight, and how to ensure patient safety when using tES devices at home. Additionally, it will provide insights into how home-based tES clinical trials can support the scaling up of tES and its long-term benefit for patients. Research Category and Technology and Methods: Clinical Research: 9. Transcranial Direct Current Stimulation (tDCS) Keywords: Scalability, tES, tDCS, home use