![]() ![]() ![]() Grenoble Alpes, Inserm, CHU Grenoble Alpes, Grenoble Institut Neurosciences, 38000 Grenoble, FranceĢ Adult Psychiatry Department CHU Grenoble Alpes 38000 Grenoble, Franceģ Early Intervention Psychiatry Department, CH Alpes-Isère, F-38000 Saint-Egrève, France.Ĥ CERMEP-Imagerie du vivant, Lyon, France.ĥ Psychiatry Department, University Hospital Saint-Etienne. The French Ministry of Health, DGOS, PHRC IR Interrégional 2020ġ Univ. Version 0.2 on June 7 th 15th, 2021, substantial modification n☁ Original French title: Efficacité et tolérance de la stimulation électrique transcrânienne fronto-temporale gauche à courant continu (tDCS) comme traitement du déficit cognitif chez les sujets atteints de schizophrénie débutante : un essai multicentrique, randomisé, contrôlé.Ĭ registration number: NCT05440955, first posted on July 1 st, 2022 Short title: tDCS for Cognitive Impairment Associated With Recent-onset Schizophrenia (STICOG) Prospectively registered on July 1 st, 2022.Įfficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in cognitive impairment associated with recent-onset schizophrenia: study protocol for a multicenter randomized double-blind sham-controlled trial 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. 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. Discussionīesides 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. 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. 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. 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 anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left auditory cortex. 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 study is designed as a randomized, double-blind, 2-arm parallel-group, sham-controlled, multicenter trial. Furthermore, the neurobiological mechanisms of cognitive changes after tDCS have been poorly explored in trials and are thus still unclear. However, a significant proportion of patients derive no cognitive benefits after tDCS treatment. 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). Cognitive deficits have been closely linked to alterations in early auditory processes (EAP) that occur in auditory cortical areas. In parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. ![]()
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