Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol for a multicenter randomized double-blind sham-controlled trial

Trials

Study Protocol

Inès Mérida¹  Nicolas Costes¹  Aurélia Gay²  Jérôme Brunelin³  Filipe Galvão⁴  Maxence Rigon⁵  Eric Fakra⁶  Irène Troprès⁷  Frédéric Haesebaert⁸  Fabien Schneider⁹  Julien Bastin^1,10  Mircea Polosan^1,11  Arnaud Pouchon^1,11  Clément Dondé^1,12  Laurent Lamalle^1,13 

[1] CERMEP-Imagerie du vivant, Lyon, France;CHU Saint-Étienne, University Department of Psychiatry and Addiction, 42055, Saint-Étienne Cedex 2, France;TAPE Laboratory, EA7423, Jean Monnet University, Saint-Étienne, France;Centre Hospitalier Le Vinatier, PSYR2 team, Bat 416 – 1st floor; 95 boulevard Pinel, 69678, F-69500, Bron cedex, France;INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, F-69000, Lyon, France;Lyon 1 University, F-69000, Villeurbanne, France;Université Jean Monnet Saint Etienne, F-42000, Saint Etienne, France;Centre Hospitalier le Vinatier, F-69500, Bron, France;Psychiatry Department, University Hospital Saint-Etienne, Saint Etienne, France;Psychiatry Department, University Hospital Saint-Etienne. INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, F-69000, Lyon, France;SUR-CL3R-PEPS, Centre Hospitalier Le Vinatier, PSYR2 team, Bat 416 – 1st floor; 95 boulevard Pinel, 69678, F-69500, Bron cedex, France;SUR-CL3R-PEPS, Centre Hospitalier Le Vinatier, PSYR2 team, Bat 416 – 1st floor; 95 boulevard Pinel, 69678, F-69500, Bron cedex, France;INSERM, U1028; CNRS, UMR5292, Lyon Neuroscience Research Center, PSYR2 Team, F-69000, Lyon, France;Lyon 1 University, F-69000, Villeurbanne, France;Service de Radiologie, CHU de Saint Etienne TAPE EA 7423, Université Jean Monnet, Saint Etienne, France;Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Grenoble Institut Neurosciences, 38000, Grenoble, France;Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Grenoble Institut Neurosciences, 38000, Grenoble, France;Adult Psychiatry Department CHU Grenoble Alpes, 38000, Grenoble, France;Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Grenoble Institut Neurosciences, 38000, Grenoble, France;Adult Psychiatry Department CHU Grenoble Alpes, 38000, Grenoble, France;Early Intervention Psychiatry Department, CH Alpes-Isère, F-38000, Saint-Egrève, France;Univ. Grenoble Alpes, UMS IRMaGe CHU Grenoble, 38000, Grenoble, France;

关键词: Psychiatry;    Schizophrenia;    RCT;    Noninvasive brain stimulation;    tDCS;    Cognitive impairment;    Early auditory processing;    Biomarker;   

DOI  :  10.1186/s13063-023-07160-z

 received in 2022-08-01, accepted in 2023-02-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundIn parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. Cognitive deficits have been closely linked to alterations in early auditory processes (EAP) that occur in auditory cortical areas. Preliminary evidence indicates that cognitive deficits in schizophrenia can be improved with a reliable and safe non-invasive brain stimulation technique called tDCS (transcranial direct current stimulation). However, a significant proportion of patients derive no cognitive benefits after tDCS treatment. Furthermore, the neurobiological mechanisms of cognitive changes after tDCS have been poorly explored in trials and are thus still unclear.MethodThe study is designed as a randomized, double-blind, 2-arm parallel-group, sham-controlled, multicenter trial. Sixty participants with recent-onset schizophrenia and cognitive impairment will be randomly allocated to receive either active (n=30) or sham (n=30) tDCS (20-min, 2-mA, 10 sessions during 5 consecutive weekdays). The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left auditory cortex. Cognition, tolerance, symptoms, general outcome and EAP (measured with EEG and multimodal MRI) will be assessed prior to tDCS (baseline), after the 10 sessions, and at 1- and 3-month follow-up. The primary outcome will be the number of responders, defined as participants demonstrating a cognitive improvement ≥Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score at 1-month follow-up. Additionally, we will measure how differences in EAP modulate individual cognitive benefits from active tDCS and whether there are changes in EAP measures in responders after active tDCS.DiscussionBesides proposing a new fronto-temporal tDCS protocol by targeting the auditory cortical areas, we aim to conduct a randomized controlled trial (RCT) with follow-up assessments up to 3 months. In addition, this study will allow identifying and assessing the value of a wide range of neurobiological EAP measures for predicting and explaining cognitive deficit improvement after tDCS. The results of this trial will constitute a step toward the use of tDCS as a therapeutic tool for the treatment of cognitive impairment in recent-onset schizophrenia.Trial registrationClinicalTrials.gov NCT05440955. Prospectively registered on July 1st, 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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