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High-density transcranial direct current stimulation to improve upper limb motor function following stroke: study protocol for a double-blind randomized clinical trial targeting prefrontal and/or cerebellar cognitive contributions to voluntary motion

  • Datos identificativos

    Identificador: imarina:9366517
    Autores:
    Corominas-Teruel, XavierBracco, MartinaFibla, MontserratSegundo, Rosa Maria SanVillalobos-Llao, MarcGallea, CecileBeranger, BenoitToba, MonicaValero-Cabre, AntoniColomina, Maria Teresa
    Resumen:
    Background Focal brain lesions following a stroke of the middle cerebral artery induce large-scale network disarray with a potential to impact multiple cognitive and behavioral domains. Over the last 20 years, non-invasive brain neuromodulation via electrical (tCS) stimulation has shown promise to modulate motor deficits and contribute to recovery. However, weak, inconsistent, or at times heterogeneous outcomes using these techniques have also highlighted the need for novel strategies and the assessment of their efficacy in ad hoc controlled clinical trials. Methods We here present a double-blind, sham-controlled, single-center, randomized pilot clinical trial involving participants having suffered a unilateral middle cerebral artery (MCA) stroke resulting in motor paralysis of the contralateral upper limb. Patients will undergo a 10-day regime (5 days a week for 2 consecutive weeks) of a newly designed high-definition transcranial direct current stimulation (HD-tDCS) protocol. Clinical evaluations (e.g., Fugl Meyer, NIHSS), computer-based cognitive assessments (visuo-motor adaptation and AX-CPT attention tasks), and electroencephalography (resting-state and task- evoked EEG) will be carried out at 3 time points: (I) Baseline, (II) Post-tDCS, and (III) Follow-up. The study consists of a four-arm trial comparing the impact on motor recovery of three active anodal tDCS conditions: ipsilesional DLPFC tDCS, contralesional cerebellar tDCS or combined DLPFC + contralesional cerebellar tDCS, and a sham tDCS intervention. The Fugl-Meyer Assessment for the upper extremity (FMA-UE) is selected as the primary outcome measure to quantify motor recovery. In every stimulation session, participants will receive 20 min of high- density tDCS stimulation (HD-tDCS) (up to 0.63 mA/ cm(2))
  • Otros:

    Autor según el artículo: Corominas-Teruel, Xavier; Bracco, Martina; Fibla, Montserrat; Segundo, Rosa Maria San; Villalobos-Llao, Marc; Gallea, Cecile; Beranger, Benoit; Toba, Monica; Valero-Cabre, Antoni; Colomina, Maria Teresa
    Departamento: Psicologia
    Autor/es de la URV: Colomina Fosch, Maria Teresa / Corominas Teruel, Xavier / Fibla Simó, Montserrat / San Segundo Mozo, Rosa María
    Palabras clave: Upper extremity Treatment outcome Transcranial direct current stimulation Tool Tdcs Stroke rehabilitation Stroke Scale Recovery of function Randomized controlled trials as topic Randomized controlled trial Plasticity Oscillations Neurorehabilitation Network connectivity Neglect Infarction, middle cerebral artery Humans Excitability Electrical-stimulation Double-blind method Cognition Brain networks
    Resumen: Background Focal brain lesions following a stroke of the middle cerebral artery induce large-scale network disarray with a potential to impact multiple cognitive and behavioral domains. Over the last 20 years, non-invasive brain neuromodulation via electrical (tCS) stimulation has shown promise to modulate motor deficits and contribute to recovery. However, weak, inconsistent, or at times heterogeneous outcomes using these techniques have also highlighted the need for novel strategies and the assessment of their efficacy in ad hoc controlled clinical trials. Methods We here present a double-blind, sham-controlled, single-center, randomized pilot clinical trial involving participants having suffered a unilateral middle cerebral artery (MCA) stroke resulting in motor paralysis of the contralateral upper limb. Patients will undergo a 10-day regime (5 days a week for 2 consecutive weeks) of a newly designed high-definition transcranial direct current stimulation (HD-tDCS) protocol. Clinical evaluations (e.g., Fugl Meyer, NIHSS), computer-based cognitive assessments (visuo-motor adaptation and AX-CPT attention tasks), and electroencephalography (resting-state and task- evoked EEG) will be carried out at 3 time points: (I) Baseline, (II) Post-tDCS, and (III) Follow-up. The study consists of a four-arm trial comparing the impact on motor recovery of three active anodal tDCS conditions: ipsilesional DLPFC tDCS, contralesional cerebellar tDCS or combined DLPFC + contralesional cerebellar tDCS, and a sham tDCS intervention. The Fugl-Meyer Assessment for the upper extremity (FMA-UE) is selected as the primary outcome measure to quantify motor recovery. In every stimulation session, participants will receive 20 min of high- density tDCS stimulation (HD-tDCS) (up to 0.63 mA/ cm(2)) with pi cm(2) electrodes. Electrode scalp positioning relative to the cortical surface (anodes and cathodes) and intensities are based on a biophysical optimization model of current distribution ensuring a 0.25 V/m impact at each of the chosen targets. Discussion Our trial will gauge the therapeutic potential of accumulative sessions of HD-tDCS to improve upper limb motor and cognitive dysfunctions presented by middle cerebral artery stroke patients. In parallel, we aim at characterizing changes in electroencephalographic (EEG) activity as biomarkers of clinical effects and at identifying potential interactions between tDCS impact and motor performance outcomes. Our work will enrich our mechanistic understanding on prefrontal and cerebellar contributions to motor function and its rehabilitation following brain damage.
    Áreas temáticas: Saúde coletiva Psicología Pharmacology (medical) Odontología Nutrição Medicine, research & experimental Medicine (miscellaneous) Medicina iii Medicina ii Medicina i Materiais Interdisciplinar Engenharias iv Enfermagem Educação física Ciências biológicas iii Ciências biológicas ii Ciências ambientais Biotecnología Administração pública e de empresas, ciências contábeis e turismo
    Acceso a la licencia de uso: https://creativecommons.org/licenses/by/3.0/es/
    Direcció de correo del autor: montserrat.fibla@urv.cat rosamaria.sansegundo@urv.cat xavier.corominas@estudiants.urv.cat mariateresa.colomina@urv.cat
    Identificador del autor: 0000-0001-6278-9324 0000-0001-7420-2914 0000-0003-2469-2753 0000-0002-5619-4874
    Fecha de alta del registro: 2024-09-28
    Versión del articulo depositado: info:eu-repo/semantics/publishedVersion
    Enlace a la fuente original: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07680-8
    URL Documento de licencia: https://repositori.urv.cat/ca/proteccio-de-dades/
    Referencia al articulo segun fuente origial: Trials. 24 (Suppl. 1): 783-
    Referencia de l'ítem segons les normes APA: Corominas-Teruel, Xavier; Bracco, Martina; Fibla, Montserrat; Segundo, Rosa Maria San; Villalobos-Llao, Marc; Gallea, Cecile; Beranger, Benoit; Toba, (2023). High-density transcranial direct current stimulation to improve upper limb motor function following stroke: study protocol for a double-blind randomized clinical trial targeting prefrontal and/or cerebellar cognitive contributions to voluntary motion. Trials, 24(Suppl. 1), 783-. DOI: 10.1186/s13063-023-07680-8
    DOI del artículo: 10.1186/s13063-023-07680-8
    Entidad: Universitat Rovira i Virgili
    Año de publicación de la revista: 2023
    Tipo de publicación: Journal Publications
  • Palabras clave:

    Medicine (Miscellaneous),Medicine, Research & Experimental,Pharmacology (Medical)
    Upper extremity
    Treatment outcome
    Transcranial direct current stimulation
    Tool
    Tdcs
    Stroke rehabilitation
    Stroke
    Scale
    Recovery of function
    Randomized controlled trials as topic
    Randomized controlled trial
    Plasticity
    Oscillations
    Neurorehabilitation
    Network connectivity
    Neglect
    Infarction, middle cerebral artery
    Humans
    Excitability
    Electrical-stimulation
    Double-blind method
    Cognition
    Brain networks
    Saúde coletiva
    Psicología
    Pharmacology (medical)
    Odontología
    Nutrição
    Medicine, research & experimental
    Medicine (miscellaneous)
    Medicina iii
    Medicina ii
    Medicina i
    Materiais
    Interdisciplinar
    Engenharias iv
    Enfermagem
    Educação física
    Ciências biológicas iii
    Ciências biológicas ii
    Ciências ambientais
    Biotecnología
    Administração pública e de empresas, ciências contábeis e turismo
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