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Sham-controlled randomized multicentre trial of transcranial direct current stimulation for prolonged disorders of consciousness |
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| Authors: | Aurore Thibaut Felipe Fregni Anna Estraneo Salvatore Fiorenza Enrique Noe Roberto Llorens Joan Ferri Rita Formisano Giovanni Morone Andreas Bender Martin Rosenfelder Gianfranco Lamberti Ekaterina Kodratyeva Sergey Kondratyev Liudmila Legostaeva Natalia Suponeva Carmen Krewer Friedemann Müller Nadia Dardenne Haroun Jedidi Steven Laureys Olivia Gosseries Nicolas Lejeune Géraldine Martens the IBIA DOC-SIG |
| Institution: | 1. Coma Science Group, GIGA-Consciousness, Centre du Cerveau2, University and University Hospital of Liège, Liège, Belgium;2. Neuromodulation Lab, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA;3. Neurorehabilitation Department, Scientific Institute for Research and Health Care, Don Carlo Gnocchi Foundation, Sant'Angelo dei Lombardi, Florence, Italy;4. IRENEA Instituto de Rehabilitación Neurológica, Fundación Hospitales Vithas, Valéncia, Spain;5. Santa Lucia Foundation, Neurorehabilitation and Scientific Institute for Research, Rome, Italy;6. Therapiezentrum Burgau, Burgau, Germany
Department of Neurology, Ludwig-Maximilians University of Munich, Munich, Germany;7. Therapiezentrum Burgau, Burgau, Germany Clinical and Biological Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany;8. Neurorehabilitation Department AUSL Piacenza - University of Parma, Piacenza, Italy;9. Almazov National Medical Research Center, Saint-Petersburg, Russia;10. Research Center of Neurology, Moscow, Russia;11. Department for Neurology, Research Group, Schoen Clinic Bad Aibling, Bad Aibling, Germany Chair of Human Movement Science, Department of Sports and Health Sciences, Technical University of Munich, Munich, Germany;12. Department for Neurology, Research Group, Schoen Clinic Bad Aibling, Bad Aibling, Germany;13. University and Hospital Biostatistics Center (B-STAT), Faculty of Medicine, University of Liège, Liège, Belgium;14. ISoSL, Hopital Valdor, Liège, Belgium;15. Coma Science Group, GIGA-Consciousness, Centre du Cerveau2, University and University Hospital of Liège, Liège, Belgium Joint International Research Unit on Consciousness, CERVO Brain Research Centre, CIUSS, University Laval, Quebec, Canada;16. Coma Science Group, GIGA-Consciousness, Centre du Cerveau2, University and University Hospital of Liège, Liège, Belgium Centre Hospitalier Neurologique William Lennox, Ottignies-Louvain-la-Neuve, Belgium |
| Abstract: | Background and purposeTranscranial direct current stimulation (tDCS) has been shown to improve signs of consciousness in a subset of patients with disorders of consciousness (DoC). However, no multicentre study confirmed its efficacy when applied during rehabilitation. In this randomized controlled double-blind study, the effects of tDCS whilst patients were in rehabilitation were tested at the group level and according to their diagnosis and aetiology to better target DoC patients who might repond to tDCS.MethodsPatients received 2 mA tDCS or sham applied over the left prefrontal cortex for 4 weeks. Behavioural assessments were performed weekly and up to 3 months’ follow-up. Analyses were conducted at the group and subgroup levels based on the diagnosis (minimally conscious state MCS] and unresponsive wakefulness syndrome) and the aetiology (traumatic or non-traumatic). Interim analyses were planned to continue or stop the trial.ResultsThe trial was stopped for futility when 62 patients from 10 centres were enrolled (44 ± 14 years, 37 ± 24.5 weeks post-injury, 18 women, 32 MCS, 39 non-traumatic). Whilst, at the group level, no treatment effect was found, the subgroup analyses at 3 months’ follow-up revealed a significant improvement for patients in MCS and with traumatic aetiology.ConclusionsTranscranial direct current stimulation during rehabilitation does not seem to enhance patients' recovery. However, diagnosis and aetiology appear to be important factors leading to a response to the treatment. These findings bring novel insights into possible cortical plasticity changes in DoC patients given these differential results according to the subgroups of patients. |
| Keywords: | anoxia coma disorders of consciousness minimally conscious sate rehabilitation stroke transcranial direct current stimulation traumatic brain injury vegetative state |