Safety and Feasibility of Tele-Supervised Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder

Davide Cappon, Tim den Boer, Caleb Jordan, Wanting Yu, Alexander Lo, Nicole LaGanke, Maria Chiara Biagi, Pawel Skorupinski, Giulio Ruffini, Oscar Morales, Eran Metzger, Bradley Manor, Alvaro Pascual-Leone, Davide Cappon, Tim den Boer, Caleb Jordan, Wanting Yu, Alexander Lo, Nicole LaGanke, Maria Chiara Biagi, Pawel Skorupinski, Giulio Ruffini, Oscar Morales, Eran Metzger, Bradley Manor, Alvaro Pascual-Leone

Abstract

Major depressive disorder (MDD) is a worldwide cause of disability in older age, especially during the covid pandemic. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that has shown encouraging efficacy for treatment of depression. Here, we investigate the feasibility of an innovative protocol where tDCS is administered within the homes of older adults with MDD (patient participants) with the help of a study companion (i.e. caregiver). We further analyze the feasibility of a remotely-hosted training program that provides the knowledge and skills to administer tDCS at home, without requiring them to visit the lab. We also employed a newly developed multi-channel tDCS system with real-time monitoring designed to guarantee the safety and efficacy of home-based tDCS. Patient participants underwent a total of 37 home-based tDCS sessions distributed over 12 weeks. The protocol consisted of three phases each lasting four weeks: an acute phase, containing 28 home-based tDCS sessions, a taper phase containing nine home-based tDCS sessions, and a follow up phase, with no stimulation sessions. We found that the home-based, remotely-supervised, study companion administered, multi-channel tDCS protocol for older adults with MDD was feasible and safe. Further, the study introduces a novel training program for remote instruction of study companions in the administration of tDCS. Future research is required to determine the translatability of these findings to a larger sample. Clinical Trial Registration: https://ichgcp.net/clinical-trials-registry/NCT04799405?term=NCT04799405&draw=2&rank=1, identifier NCT04799405.

Keywords: COVID-19; depression; home-based intervention; non-invasive brain stimulation; transcranial direct current stimulation (tDCS).

Conflict of interest statement

MB and PS were employed by company Neuroelectrics. GR is a shareholder and works for Neuroelectrics. AP-L is a co-founder of Linus Health and TI Solutions AG; serves on the scientific advisory boards for Starlab Neuroscience, Magstim Inc., Radiant Hearts, and MedRhythms; and is listed as an inventor on several issued and pending patents on the real-time integration of non-invasive brain stimulation with electroencephalography and magnetic resonance imaging. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Cappon, den Boer, Jordan, Yu, Lo, LaGanke, Biagi, Skorupinski, Ruffini, Morales, Metzger, Manor and Pascual-Leone.

Figures

FIGURE 1
FIGURE 1
Study design. The green vertical lines represent a day with a scheduled tDCS session, whereas the gray vertical lines represent a day without a tDCS session.
FIGURE 2
FIGURE 2
The multichannel tDCS intervention for major depressive disorder (MDD). (A) The red rectangle represents the left DLPFC, which is inclusive of evidence-based TMS targets for depression as reported by Fox et al. (2012) and the Beam F3 method (Trapp et al., 2020). First, the MNI coordinates [x,y,z] of the TMS hotspots (1: [−40.6, 41.7, 34.3; −41.5, 41.1, 33.4], 2: [39.3, 46.2 27.5; −41.3, 48.9, 27.7], 3:[−50, 30,36], 4: [−33.6, 30.8, 51.11]) were remapped on the cortex of the default brain model. Then, in order to obtain the final target map considered for this study, we drew an inner hotspot area encompassing all the mapped points and surrounded it by a buffer area. (B) The optimized four-electrode montage developed in this study to target the left DLPFC (anode shown in red, cathodes in blue) and normal component of the electric field to the cortex induced by the montage (V/m). (C) The Starstim®-Home Kit (Neuroelectrics Corp.) was used to administer stimulation.
FIGURE 3
FIGURE 3
HSL Remote Training and Supervision Program for Home-Based tDCS. (A) Study companions are provided with a training curriculum for self-study. (B) The study companion attends practice sessions with an evaluation at the end. (C) Once certified in independent tDCS administration, study companions can access remote assistance during the home-based tDCS sessions. The images in this figure were created using Apple’s iOS 12 camera filter: Comic Book, and the other elements of the figure were created using Comic Life 3 by plasq LLC.
FIGURE 4
FIGURE 4
Primary clinical outcome: MADRS results. The purple shaded area in the graph B represents a ≥50% decrease in the MADRS score, which is used as a clinical response threshold.

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