TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study

Abstract

The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials. This is due to its positive safety profile, cost-effectiveness, and potential scalability for a wide outreach in clinical practice. Here, we provide a systematic review of the available studies and also a report on the results of a randomized controlled trial (RCT) on tDCS at home for the treatment of MDD. This trial had to be prematurely terminated due to safety concerns. The HomeDC trial is a double-blinded, placebo-controlled, parallel-group study. Patients with MDD (DSM-5) were randomized to active or sham tDCS. Patients conducted tDCS at home for 6 weeks with 5 sessions/week (30 min at 2 mA) anode over F3, cathode over F4. Sham tDCS resembled active tDCS, with ramp-in and ramp-out periods, but without intermittent stimulation. The study was prematurely terminated due to an accumulation of adverse events (AEs, skin lesions), so that only 11 patients were included. Feasibility was good. Safety monitoring was not sufficient enough to detect or prevent AEs within an appropriate timeframe. Regarding antidepressant effects, the reduction in depression scales over time was significant. However, active tDCS was not superior to sham tDCS in this regard. Both the conclusions from this review and the HomeDC trial show that there are several critical issues with the use of tDCS at home that need to be addressed. Nevertheless the array of transcranial electric simulation (TES) methods that this mode of application offers, including tDCS, is highly interesting and warrants further investigation in high quality RCTs. Trial registration: www.clinicaltrials.gov. Trial registration number: NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505. Graphical abstract *Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers) **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71. For more information, visit: http://www.prisma-statement.org/

Home-based transcranial direct current stimulation RCT in major depression

“…The present protocol demonstrated greater efficacy and safety relative to recent home-based tDCS trials. 32,33 One trial had terminated early, enrolling 11 MDD participants, due to adverse events of skin lesions from an accumulation of skin burns. 32 Another trial was a single-blind RCT of tDCS augmentation to antidepressant medication, consisting of hybrid clinic- and home-based tDCS sessions, which found improved self-report depressive symptoms but not in clinician-based ratings at 6 weeks.…”

“…32,33 One trial had terminated early, enrolling 11 MDD participants, due to adverse events of skin lesions from an accumulation of skin burns. 32 Another trial was a single-blind RCT of tDCS augmentation to antidepressant medication, consisting of hybrid clinic- and home-based tDCS sessions, which found improved self-report depressive symptoms but not in clinician-based ratings at 6 weeks. 33 The present protocol was a fully remote, double-blind, sham-controlled RCT with real-time clinical assessments by video conference.…”

Acceptability of home-based transcranial direct current stimulation (tDCS) in major depression: a qualitative analysis of individual experiences

“…Nuances such as being able to distinguish participant understanding of novel sensations versus side effect profiles, which require intervention may assist in creating comprehensive safety monitoring screen tools for remote home-based tDCS protocols to prevent and detect cumulative adverse effects seen in recent remote studies (e.g. Kumpf et al , 2023).…”

Home-based transcranial direct current stimulation in bipolar depression: an open-label treatment study of clinical outcomes, acceptability and adverse events

“…Monitoring of side effects with an online daily report has also been effective in a home-based trial (Alonzo et al, 2019) as well as periodic monitoring visits in two large home-based trials (Borrione et al, 2024; Woodham et al, 2023). Safety reporting for home-based tDCS treatments is an important consideration as reports of skin burns at the electrode site have been reported (Kumpf et al, 2023; Woodham et al, 2023), which can occur with insufficient moistening with conductive saline solution (Kortteenniemi et al, 2019) or application of tap water to moisten sponges (Frank et al, 2010; Palm et al, 2008). If participants encounter potential challenges in managing side effects independently, it could lead to the exacerbation of adverse events and eventual discontinuation of treatment.…”