ABSTRACT
Enhanced behavioral interventions are gaining increasing interest as innovative treatment strategies for major depressive disorder (MDD). In this study protocol, we propose to examine the synergistic effects of a self-administered home-treatment, encompassing transcranial direct current stimulation (tDCS) along with a video game based training of attentional control. The study is designed as a two-arm, double-blind, randomized and placebo-controlled multi-center trial (ClinicalTrials.gov: NCT04953208). At three study sites (Israel, Latvia, and Germany), 114 patients with a primary diagnosis of MDD undergo 6 weeks of intervention (30 × 30 min sessions). Patients assigned to the intervention group receive active tDCS (anode F3 and cathode F4; 2 mA intensity) and an action-like video game, while those assigned to the control group receive sham tDCS along with a control video game. An electrode-positioning algorithm is used to standardize tDCS electrode positioning. Participants perform their designated treatment at the clinical center (sessions 1-5) and continue treatment at home under remote supervision (sessions 6-30). The endpoints are feasibility (primary) and safety, treatment efficacy (secondary, i.e., change of Montgomery-Åsberg Depression Rating Scale (MADRS) scores at week six from baseline, clinical response and remission, measures of social, occupational, and psychological functioning, quality of life, and cognitive control (tertiary). Demonstrating the feasibility, safety, and efficacy of this novel combined intervention could expand the range of available treatments for MDD to neuromodulation enhanced interventions providing cost-effective, easily accessible, and low-risk treatment options.ClinicalTrials.gov: NCT04953208.
Subject(s)
Depressive Disorder, Major , Transcranial Direct Current Stimulation , Humans , Depressive Disorder, Major/therapy , Transcranial Direct Current Stimulation/methods , Depression/therapy , Quality of Life , Treatment Outcome , Double-Blind Method , Cognition , Brain , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
We report a case of spontaneous temporary resolution of congenital hydrocephalus due to drainage into the subdural space, which is not a physiological space for cerebrospinal fluid (CSF). This is the first report of spontaneous drainage of CSF into the subdural space, and we term it "ventriculosubdurostomy." We highlight the fact that spontaneous resolution of hydrocephalus due to drainage into a nonphysiological CSF space is temporary.
