Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression

Non-invasive transcranial brain stimulation (NTBS) techniques are well established in experimental neuroscience and have been increasingly used in the treatment of mental illnesses, especially depressive disorders, in the last years. Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert antidepressant effects. Treatment with tDCS for MDD requires sessions several times a week, which is very time-consuming and stressful for patients, as they have to come to the clinic almost every day. At the same time, the availability of non-drug therapies for MDD is limited, especially in more rural areas. The home-treatment approach with tDCS for MDD could address this problem and is of increasing interest in times of the Covid-19 pandemic, when frequent clinic visits should be avoided. There are some studies on the home-treatment approach with tDCS for different, mainly neurological disorders such as parkinson\'s disease, multiple sclerosis and chronic pain. For the treatment of MDD with tDCS in the home treatment setting, only one pilot study has been published so far, which shows good feasibility and good antidepressant effects. However, this study does not include a placebo condition. The study will be conducted in a double-blind, placebo-controlled, parallel-group design with 16 patients per group. Patients with MDD do a 6-weeks self-administered treatment with prefrontal tDCS (anode: F3, cathode: F4, 5 sessions/week, 30min/day, 2mA intensity) or sham tDCS (parameters correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation) as adjunctive treatment to a serotonergic medication or alone. For the continuous monitoring of the technical parameters and thus for quality control and for blinding, the same technical achievements as in the DepressionDC trial are used. As a new feature, a cap is used for easier handling in the home-treatment setting, in which electrodes are already integrated at the F3 and F4 points. This study aims to investigate the feasibility and effectiveness of 6 weeks of daily home treatment with tDCS for MDD. According to the DepressionDC trial, the primary outcome parameters are the decrease in the MADRS after 6 weeks and at the end of the follow-up phase, as well as the feasibility based on the dropout rates and the outcome in the comfort rating questionnaire. Additional baseline examinations with cMRI and e-field modelling will investigate the possible influence of the individual e-field on the outcome.