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
Abstract Background In 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 audi...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07160-z |
| _version_ | 1797863580096266240 |
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| author | Clément Dondé Julien Bastin Arnaud Pouchon Nicolas Costes Eric Fakra Filipe Galvão Aurélia Gay Frédéric Haesebaert Laurent Lamalle Inès Mérida Maxence Rigon Fabien Schneider Irène Troprès Jérôme Brunelin Mircea Polosan |
| author_facet | Clément Dondé Julien Bastin Arnaud Pouchon Nicolas Costes Eric Fakra Filipe Galvão Aurélia Gay Frédéric Haesebaert Laurent Lamalle Inès Mérida Maxence Rigon Fabien Schneider Irène Troprès Jérôme Brunelin Mircea Polosan |
| author_sort | Clément Dondé |
| collection | DOAJ |
| description | Abstract Background In 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. Method The 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. Discussion Besides 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 registration ClinicalTrials.gov NCT05440955. Prospectively registered on July 1st, 2022. |
| first_indexed | 2024-04-09T22:38:53Z |
| format | Article |
| id | doaj.art-023e5f8a92b644789b6512ba35da71c3 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:38:53Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-023e5f8a92b644789b6512ba35da71c32023-03-22T12:18:08ZengBMCTrials1745-62152023-02-0124111710.1186/s13063-023-07160-zEfficacy 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 trialClément Dondé0Julien Bastin1Arnaud Pouchon2Nicolas Costes3Eric Fakra4Filipe Galvão5Aurélia Gay6Frédéric Haesebaert7Laurent Lamalle8Inès Mérida9Maxence Rigon10Fabien Schneider11Irène Troprès12Jérôme Brunelin13Mircea Polosan14Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Grenoble Institut NeurosciencesUniv. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Grenoble Institut NeurosciencesUniv. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Grenoble Institut NeurosciencesCERMEP-Imagerie du vivantPsychiatry Department, University Hospital Saint-Etienne. INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 TeamCentre Hospitalier le VinatierCHU Saint-Étienne, University Department of Psychiatry and AddictionSUR-CL3R-PEPS, Centre Hospitalier Le Vinatier, PSYR2 teamUniv. Grenoble Alpes, UMS IRMaGe CHU GrenobleCERMEP-Imagerie du vivantPsychiatry Department, University Hospital Saint-EtienneService de Radiologie, CHU de Saint Etienne TAPE EA 7423, Université Jean MonnetSUR-CL3R-PEPS, Centre Hospitalier Le Vinatier, PSYR2 teamCentre Hospitalier Le Vinatier, PSYR2 teamUniv. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Grenoble Institut NeurosciencesAbstract Background In 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. Method The 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. Discussion Besides 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 registration ClinicalTrials.gov NCT05440955. Prospectively registered on July 1st, 2022.https://doi.org/10.1186/s13063-023-07160-zPsychiatrySchizophreniaRCTNoninvasive brain stimulationtDCSCognitive impairment |
| spellingShingle | Clément Dondé Julien Bastin Arnaud Pouchon Nicolas Costes Eric Fakra Filipe Galvão Aurélia Gay Frédéric Haesebaert Laurent Lamalle Inès Mérida Maxence Rigon Fabien Schneider Irène Troprès Jérôme Brunelin Mircea Polosan 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 Psychiatry Schizophrenia RCT Noninvasive brain stimulation tDCS Cognitive impairment |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Psychiatry Schizophrenia RCT Noninvasive brain stimulation tDCS Cognitive impairment |
| url | https://doi.org/10.1186/s13063-023-07160-z |
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