Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols

Abstract

The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: (1) training of staff in tDCS treatment and supervision; (2) assessment of the user’s capability to participate in tDCS remotely; (3) ongoing training procedures and materials including assessments of the user and/or caregiver; (4) simple and fail-safe electrode preparation techniques and tDCS headgear; (5) strict dose control for each session; (6) ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol), with corresponding corrective steps as required; (7) monitoring for treatment-emergent adverse effects; (8) guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care) following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

Delayed pain decrease following M1 tDCS in spinal cord injury: A randomized controlled clinical trial

“…Therefore, it is essential to develop strategies to improve patients' adherence to collect exact data, to determine the exact proportion of patients responding to tDCS, as well as the amount of pain relief tDCS can induce. One solution that has been tested in patients with Parkinson Disease is the use of a home-based device with close supervision by researchers and clinicians [45]. In this study, the compliance was as high as 100% (for a total of 40 sessions) and no adverse events occurred, showing that remotely supervised tDCS could be a valuable option to reduce the number of drop-outs, in addition to represent a step forward in the clinical translation of tDCS.…”

Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state

“…Of course, home-based tDCS should always be monitored under close clinical supervision. To this end, Charvet and colleagues proposed 8 recommendations, which we followed in this study [29]. The same team applied these principles in a remotely-supervised tDCS randomized clinical trial (RCT) associated with cognitive training in patients with multiple sclerosis [30].…”

Brain Stimulation for Cognitive Enhancement in the Older Person: State of the Art and Future Directions

“…In a less controlled environment, the so-called DIY-tDCS movement has seen people construct and use tDCS devices in their own home. The purposes, protocols and results of at-home users vary widely (Jwa 2015), and harnessing the enthusiasm of this community would be a valuable source of information in designing safe and effective protocols for naturalistic stimulation procedures (Charvet et al 2015;Davis 2016).…”