a b s t r a c tBackground: Patients with chronic disorders of consciousness face a significant lack of treatment options. Objective: We aimed at investigating the feasibility and the behavioral effects of home-based transcranial direct current stimulation (tDCS), applied by relatives or caregivers, in chronic patients in minimally conscious state (MCS). Methods: Each participant received, in a randomized order, 20 sessions of active and 20 sessions of sham tDCS applied over the prefrontal cortex for 4 weeks; separated by 8 weeks of washout. Level of consciousness was assessed using the Coma Recovery Scale-Revised before the first stimulation (baseline), at the end of the 20 tDCS sessions (direct effects) and 8 weeks after the end of each stimulation period (long-term effects). Reported adverse events and data relative to the adherence (i.e., amount of sessions effectively received) were collected as well. Results: Twenty-seven patients completed the study and 22 patients received at least 80% of the stimulation sessions. All patients tolerated tDCS well, no severe adverse events were noticed after real stimulation and the overall adherence (i.e., total duration of stimulation) was good. A moderate effect size (0.47 and 0.53, for modified intention to treat and per protocol analysis, respectively) was observed at the end of the 4 weeks of tDCS in favor of the active treatment. Conclusions: We demonstrated that home-based tDCS can be used adequately outside a research facility or hospital by patients' relatives or caregivers. In addition, 4 weeks of tDCS moderately improved the recovery of signs of consciousness in chronic MCS patients.© 2018 Elsevier Inc. All rights reserved.
IntroductionPatients who suffered from a severe brain injury and stay with a disorder of consciousness (DOC) represent a challenging population to treat since, by definition, these patients are unable to communicate, and therefore to participate in active rehabilitation programs. Currently, their treatment options are limited, especially in the chronic setting. Several drugs to improve the level of consciousness have been studied (e.g., zolpidem, levodopa or baclofen) [1]. However, so far, only amantadine showed significant clinical effects [2]. Recently, transcranial direct current stimulation (tDCS) showed promising results in patients in a minimally conscious state (MCS e i.e., showing fluctuating but reproducible signs of consciousness, such as response to command or visual pursuit for instance, while being unable to functionally communicate) while patients in unresponsive wakefulness syndrome (UWS e i.e., only showing cyclic eye-opening and reflexive behaviors) seem to be less responsive to that treatment. We demonstrated that a single session of tDCS, applied with the anode over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the contralateral supraorbital area, induced transient clinical improvement [4], as