Géraldine Martens1, Nicolas Lejeune2, Anthony Terrence O'Brien3, Felipe Fregni3, Charlotte Martial4, Sarah Wannez4, Steven Laureys5, Aurore Thibaut6. 1. Coma Science Group, GIGA Research, GIGA-Consciousness & Neurology Department, University and University Hospital of Liege, Liege, Belgium. Electronic address: geraldine.martens@ulg.ac.be. 2. Coma Science Group, GIGA Research, GIGA-Consciousness & Neurology Department, University and University Hospital of Liege, Liege, Belgium; Centre Hospitalier Neurologique William Lennox, Saint-Luc University Clinics, Université Catholique de Louvain, Belgium. 3. Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA. 4. Coma Science Group, GIGA Research, GIGA-Consciousness & Neurology Department, University and University Hospital of Liege, Liege, Belgium. 5. Coma Science Group, GIGA Research, GIGA-Consciousness & Neurology Department, University and University Hospital of Liege, Liege, Belgium. Electronic address: coma@uliege.be. 6. Coma Science Group, GIGA Research, GIGA-Consciousness & Neurology Department, University and University Hospital of Liege, Liege, Belgium; Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.
Abstract
BACKGROUND: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.
RCT Entities:
BACKGROUND: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 MCSpatients.
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