Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes

Abstract

Current treatments for major depressive disorder (MDD) have limited effectiveness and acceptability. Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation method that has demonstrated treatment efficacy in MDD. tDCS requires daily sessions, however clinical trials have been conducted in research centers requiring repeated visits. As tDCS is portable and safe, it could be provided at home. We developed a home-based protocol with real-time supervision, and we examined the clinical outcomes, acceptability and feasibility. Participants were 26 MDD (19 women), mean age 40.9 ± 14.2 years, in current depressive episode of moderate to severe severity (mean 17-item Hamilton Rating Scale for Depression (HAMD) score 19.12 ± 2.12). tDCS was provided in a bilateral frontal montage, F3 anode, F4 cathode, 2 mA, each session 30 min, in a 6-week trial, for a total 21 sessions. Participants maintained their current treatment (antidepressant medication, psychotherapy, or were enrolled in online CBT). Two tDCS device brands were used, and a research team member was present in person or by real-time video call at each session. 92.3% MDD participants (n = 24) completed the 6-week treatment. Attrition rate was 7.7%. There was a significant improvement in depressive symptoms following treatment (mean HAMD 5.33 ± 2.33), which was maintained at 6 months (mean HAMD 5.43 ± 2.73). Acceptability was endorsed as "very acceptable" or "quite acceptable" by all participants. Due to the open-label feasibility design, efficacy findings are preliminary. In summary, home-based tDCS with real-time supervision was associated with significant clinical improvements and high acceptability which were maintained in the long term.