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://clinicaltrials.gov/ct2/show/NCT04799405?term=NCT04799405&draw=2&rank=1, identifier NCT04799405.
Highlights
Major depressive disorder (MDD) is highly prevalent and a leading cause of disability worldwide (Kupfer et al, 2012)
Two withdrew from the study during the first week of Transcranial direct current stimulation (tDCS) sessions due to medical conditions unrelated to study treatment
The training program was well-received by the three study companions and all three were able to independently and safely administer the tDCS after the three planned practice sessions
Summary
Major depressive disorder (MDD) is highly prevalent and a leading cause of disability worldwide (Kupfer et al, 2012). Older age is a significant predictor of an unfavorable course of depression (Mitchell and Subramaniam, 2005), reduced likelihood of treatment response (Licht-Strunk et al, 2007; Tedeschini et al, 2011), and increased risk of relapse (Beekman et al, 2002). For patients with medication-resistant MDD, a few neuromodulation methods are available, including electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS). These are effective interventions; they require access to suitable clinic facilities, which was recently challenging due to the COVID-19 pandemic restrictions. The COVID-19 pandemic has increased the risk of depression due to social isolation, loneliness, high stress and fear of infection. There is an urgent need for a safe, effective, home-based intervention for acute, medication-resistant episodes of uni- or bi-polar MDD
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