Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Abstract

The remotely supervised tDCS (RS-tDCS) protocol enables participation from home through guided and monitored self-administration of tDCS treatment while maintaining clinical standards. The current consensus regarding the efficacy of tDCS is that multiple treatment sessions are needed to observe targeted behavioral reductions in symptom burden. However, the requirement for patients to travel to clinic daily for stimulation sessions presents a major obstacle for potential participants, due to work or family obligations or limited ability to travel. This study presents a protocol that directly overcomes these obstacles by eliminating the need to travel to clinic for daily sessions.This is an updated protocol for remotely supervised self-administration of tDCS for daily treatment sessions paired with a program of computer-based cognitive training for use in clinical trials. Participants only need to attend clinic twice, for a baseline and study-end visit. At baseline, participants are trained and provided with a study stimulation device, and a small laptop computer. Participants then complete the remainder of their stimulation sessions at home while they are monitored via videoconferencing software.Participants complete computerized cognitive remediation during stimulation sessions, which may serve a therapeutic role or as a "placeholder" for other computer-based activity. Computers are enabled for real-time monitoring and remote control by study staff.Outcome measures that assess feasibility and tolerance are administered remotely with the aid of visual analogue scales that are presented onscreen. Following completion of all RS-tDCS sessions, participants return to clinic for a study end visit in which all study equipment is returned.Results support the safety, feasibility, and scalability of the RS-tDCS protocol for use in clinical trials. Across 46 patients, 748 RS-tDCS sessions have been completed. This protocol serves as a model for use in future clinical trials involving tDCS.

Feasibility of Remotely Supervised Transcranial Direct Current Stimulation and Cognitive Remediation: A Systematic Review

“…The remaining 33 published articles reported on a sample size range of 9-135 participants. Studies were published between the years of 1995-2018, and targeted multiple diagnoses including but not limited to: multiple sclerosis [2,19,20,[26][27][28]45], Parkinson's disease [2,30,43], brain injury [44,52], and schizophrenia [29, 8 37, 46, 48, 49, 51, 55]. Only three papers [21-23] and one case study [24] were published with AD as the target population, with an additional study targeting mild vascular dementia [25].…”

“…Of the 16 tDCS studies reviewed, five were double blind randomized controlled trials [2,27,[31][32][33], two were single blind randomized sham controlled trials [25,34], two were pilot studies [20, 28], two featured a randomized double-blind cross-over design [18,35], two were open label studies [27,30], one was a multiple case study with four participants [36] and two were single case studies [24,29].…”

“…The following inclusion criteria were applied: (1) articles published in English; (2) original research with human participants, (3) home-based intervention. Excluded papers were: (1) articles reporting tDCS data from research settings, such as laboratories, hospitals, clinics, and research centers; (2) review, guideline and protocol papers without reporting original research; (3) articles that used animals as study subjects, (4) articles reporting do-it-yourself (DIY) tDCS use.…”

“…There were 16 studies total that met the inclusion criteria. Studies targeted a range of symptoms and disorders, but most research focused on multiple sclerosis [2,20,[26][27][28], schizophrenia [29], Parkinson's disease [2,30] and dementia [24,25].…”

“…Currently, 47 million people worldwide suffer from dementia, with nearly 10 million new cases each year, making it the 7th global leading cause of death [1]. Alzheimer's Dementia (AD) represents a growing health concern and contributing to 60-70% of dementia cases worldwide [2,3]. Given the growing prevalence rate of AD, preventative interventions and treatments that target individuals on a population level are crucial.…”