Article (Scientific journals)
Sham-controlled randomized multicentre trial of transcranial direct current stimulation for prolonged disorders of consciousness.
Thibaut, Aurore; Fregni, Felipe; Estraneo, Anna et al.
2023In European Journal of Neurology
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Keywords :
anoxia; coma; disorders of consciousness; minimally conscious sate; rehabilitation; stroke; transcranial direct current stimulation; traumatic brain injury; vegetative state; Neurology; Neurology (clinical)
Abstract :
[en] [en] BACKGROUND AND PURPOSE: Transcranial 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. METHODS: Patients 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. RESULTS: The 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. CONCLUSIONS: Transcranial 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.
Disciplines :
Neurosciences & behavior
Author, co-author :
Thibaut, Aurore  ;  Université de Liège - ULiège > GIGA > GIGA Consciousness - Coma Science Group
Fregni, Felipe;  Neuromodulation Lab, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA
Estraneo, Anna;  Neurorehabilitation Department, Scientific Institute for Research and Health Care, Don Carlo Gnocchi Foundation, Sant'Angelo dei Lombardi, Florence, Italy
Fiorenza, Salvatore;  Neurorehabilitation Department, Scientific Institute for Research and Health Care, Don Carlo Gnocchi Foundation, Sant'Angelo dei Lombardi, Florence, Italy
Noe, Enrique;  IRENEA Instituto de Rehabilitación Neurológica, Fundación Hospitales Vithas, Valéncia, Spain
Llorens, Roberto ;  IRENEA Instituto de Rehabilitación Neurológica, Fundación Hospitales Vithas, Valéncia, Spain ; Neurorehabilitation and Brain Research Group, Instituto Universitario de Investigación en Tecnología Centrada en el Ser Humano, Universitat Politècnica de València, Valencia, Spain
Ferri, Joan;  IRENEA Instituto de Rehabilitación Neurológica, Fundación Hospitales Vithas, Valéncia, Spain
Formisano, Rita ;  Santa Lucia Foundation, Neurorehabilitation and Scientific Institute for Research, Rome, Italy
Morone, Giovanni ;  Santa Lucia Foundation, Neurorehabilitation and Scientific Institute for Research, Rome, Italy
Bender, Andreas;  Therapiezentrum Burgau, Burgau, Germany ; Department of Neurology, Ludwig-Maximilians University of Munich, Munich, Germany
Rosenfelder, Martin;  Therapiezentrum Burgau, Burgau, Germany ; Clinical and Biological Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany
Lamberti, Gianfranco;  Neurorehabilitation Department AUSL Piacenza - University of Parma, Piacenza, Italy
Kodratyeva, Ekaterina;  Almazov National Medical Research Center, Saint-Petersburg, Russia
Kondratyev, Sergey;  Almazov National Medical Research Center, Saint-Petersburg, Russia
Legostaeva, Liudmila;  Research Center of Neurology, Moscow, Russia
Suponeva, Natalia;  Research Center of Neurology, Moscow, Russia
Krewer, Carmen;  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
Müller, Friedemann;  Department for Neurology, Research Group, Schoen Clinic Bad Aibling, Bad Aibling, Germany
Dardenne, Nadia  ;  Université de Liège - ULiège > Département des sciences de la santé publique
Jedidi, Haroun ;  Université de Liège - ULiège > Département des sciences cliniques > Neuroimagerie des troubles de la mémoire et revalidation cognitive ; ISoSL, Hopital Valdor, Liège, Belgium
Laureys, Steven  ;  Centre Hospitalier Universitaire de Liège - CHU > > Centre du Cerveau² ; Joint International Research Unit on Consciousness, CERVO Brain Research Centre, CIUSS, University Laval, Quebec, Canada
Gosseries, Olivia  ;  Université de Liège - ULiège > GIGA > GIGA Consciousness - Coma Science Group
Lejeune, Nicolas  ;  Université de Liège - ULiège > GIGA > GIGA Consciousness - Coma Science Group ; Centre Hospitalier Neurologique William Lennox, Ottignies-Louvain-la-Neuve, Belgium
Martens, Géraldine  ;  Université de Liège - ULiège > Département des sciences de la motricité
IBIA DOC-SIG
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Language :
English
Title :
Sham-controlled randomized multicentre trial of transcranial direct current stimulation for prolonged disorders of consciousness.
Publication date :
09 July 2023
Journal title :
European Journal of Neurology
ISSN :
1351-5101
eISSN :
1468-1331
Publisher :
John Wiley and Sons Inc, England
Peer reviewed :
Peer Reviewed verified by ORBi
Funding text :
The ULiege team also thank the University Hospital of Liège, the Belgian National Funds for Scientific Research (FRS‐FNRS), the European Union's Horizon 2020 Framework Programme for Research and Innovation under the Specific Grant Agreement No. 945539 (Human Brain Project SGA3), the European Space Agency (ESA) and the Belgian Federal Science Policy Office (BELSPO) in the framework of the PRODEX Programme, ‘Fondazione Europea di Ricerca Biomedica’, the BIAL Foundation, the Mind Science Foundation and the European Commission, the fund Generet, the King Baudouin Foundation and the AstraZeneca Foundation. N.L. is a postdoctoral researcher, A.T. and O.G. are research associates and S.L. is research director at the F.R.S‐FNRS. The Don Carlo Gnocchi Foundation team also thank the Italian Ministry of Health Current Research Funding, Don Gnocchi Foundation Ricerca Corrente 2019–2021.
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