Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Abstract

ImportanceTranscranial direct current stimulation (tDCS) is moderately effective for depression when applied by trained staff. It is not known whether self-applied tDCS, combined or not with a digital psychological intervention, is also effective.ObjectiveTo determine whether fully unsupervised home-use tDCS, combined with a digital psychological intervention or digital placebo, is effective for a major depressive episode.Design, Setting, and ParticipantsThis was a double-blinded, sham-controlled, randomized clinical trial with 3 arms: (1) home-use tDCS plus a digital psychological intervention (double active); (2) home-use tDCS plus digital placebo (tDCS only), and (3) sham home-use tDCS plus digital placebo (double sham). The study was conducted between April 2021 and October 2022 at participants’ homes and at Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil. Included participants were aged 18 to 59 years with major depression and a Hamilton Depression Rating Scale, 17-item version (HDRS-17), score above 16, a minimum of 8 years of education, and access to a smartphone and internet at home. Exclusion criteria were other psychiatric disorders, except for anxiety; neurologic or clinical disorders; and tDCS contraindications.InterventionstDCS was administered in 2-mA, 30-minute prefrontal sessions for 15 consecutive weekdays (1-mA, 90-second duration for sham) and twice-weekly sessions for 3 weeks. The digital intervention consisted of 46 sessions based on behavioral therapy. Digital placebo was internet browsing.Main Outcomes and MeasuresChange in HDRS-17 score at week 6.ResultsOf 837 volunteers screened, 210 participants were enrolled (180 [86%] female; mean [SD] age, 38.9 [9.3] years) and allocated to double active (n = 64), tDCS only (n = 73), or double sham (n = 73). Of the 210 participants enrolled, 199 finished the trial. Linear mixed-effects models did not reveal statistically significant group differences in treatment by time interactions for HDRS-17 scores, and the estimated effect sizes between groups were as follows: double active vs tDCS only (Cohen d, 0.05; 95% CI, −0.48 to 0.58; P = .86), double active vs double sham (Cohen d, −0.20; 95% CI, −0.73 to 0.34; P = .47), and tDCS only vs double sham (Cohen d, −0.25; 95% CI, −0.76 to 0.27; P = .35). Skin redness and heat or burning sensations were more frequent in the double active and tDCS only groups. One nonfatal suicide attempt occurred in the tDCS only group.Conclusions and RelevanceUnsupervised home-use tDCS combined with a digital psychological intervention or digital placebo was not found to be superior to sham for treatment of a major depressive episode in this trial.Trial RegistrationClinicalTrials.gov Identifier: NCT04889976

Multichannel tDCS with Advanced Targeting for Major Depressive Disorder: A Tele-Supervised At-Home Pilot Study

“…The results in this study are similar to those in the active arm in the recent placebo-controlled study by Salehinejad et al (2024). They contrast with earlier recent studies that failed to show efficacy with respect to sham (Burkhardt, 2023, Borrione, 2024). An important difference in our study is the dose and the use of a specifically designed multichannel montage to target the region of interest (these other studies use a standard bifrontal montage with two large sponge electrodes).…”

“…Finally, some recent studies have produced negative results. In Borrione et al (2024), a randomized clinical trial assessing the effectiveness of unsupervised home tDCS for major depression, no significant treatment benefits were observed. The study included 210 participants who were administered tDCS with or without a digital psychological intervention versus a sham control.…”

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

“…Remote real-time supervision during stimulation allowed for close monitoring of adverse events and ensuring that the device was used correctly. 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).…”

Does tDCS Selectively Modulate the Pre-frontal Cortex Hemodynamics? An Immediate Effect-Controlled Trial on Depressed and Healthy People

“…Another network meta-analysis showed anodal tDCS over frontal lobe (F3-F4 montage) significantly improving depressive symptoms compared to sham controls with higher response rates than other types of non-invasive brain stimulation [2]. However, novel findings of 2 large-sample randomized controlled studies raised doubts over the tDCS efficacy [3,4]. They used unsupervised home-use tDCS alone or combined with a digital psychological intervention or digital Disclaimer/Publisher's Note: The statements, opinions, and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s).…”