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 DOI Creative Commons
Xavier Corominas-Teruel, Martina Bracco, Montserrat Fibla

et al.

Trials, Journal Year: 2023, Volume and Issue: 24(1)

Published: Dec. 4, 2023

Abstract Background Focal brain lesions following a stroke of the middle cerebral artery induce large-scale network disarray with potential to impact multiple cognitive and behavioral domains. Over last 20 years, non-invasive neuromodulation via electrical (tCS) stimulation has shown promise modulate motor deficits contribute recovery. However, weak, inconsistent, or at times heterogeneous outcomes using these techniques have also highlighted need for novel strategies assessment their efficacy in ad hoc controlled clinical trials. Methods We here present double-blind, sham-controlled, single-center, randomized pilot trial involving participants having suffered unilateral (MCA) resulting paralysis contralateral upper limb. Patients will undergo 10-day regime (5 days week 2 consecutive weeks) newly designed high-definition transcranial direct current (HD-tDCS) protocol. Clinical evaluations (e.g., Fugl Meyer, NIHSS), computer-based assessments (visuo-motor adaptation AX-CPT attention tasks), electroencephalography (resting-state task-evoked EEG) be carried out 3 time points: (I) Baseline, (II) Post-tDCS, (III) Follow-up. The study consists four-arm comparing on recovery three active anodal tDCS conditions: ipsilesional DLPFC tDCS, contralesional cerebellar combined + sham intervention. Fugl-Meyer Assessment extremity (FMA-UE) is selected as primary outcome measure quantify In every session, receive min high-density (up 0.63 mA/ $${\mathrm{cm}}^{2}$$ cm 2 ) $${\mathrm{\pi cm}}^{2}$$ π electrodes. Electrode scalp positioning relative cortical surface (anodes cathodes) intensities are based biophysical optimization model distribution ensuring 0.25 V/m each chosen targets. Discussion Our gauge therapeutic accumulative sessions HD-tDCS improve limb dysfunctions presented by patients. parallel, we aim characterizing changes electroencephalographic (EEG) activity biomarkers effects identifying interactions between performance outcomes. work enrich our mechanistic understanding prefrontal contributions function its rehabilitation damage. Trial registration ClinicalTrials.gov NCT05329818. April 15, 2022.

Language: Английский

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 DOI Creative Commons
Xavier Corominas-Teruel, Martina Bracco, Montserrat Fibla

et al.

Trials, Journal Year: 2023, Volume and Issue: 24(1)

Published: Dec. 4, 2023

Abstract Background Focal brain lesions following a stroke of the middle cerebral artery induce large-scale network disarray with potential to impact multiple cognitive and behavioral domains. Over last 20 years, non-invasive neuromodulation via electrical (tCS) stimulation has shown promise modulate motor deficits contribute recovery. However, weak, inconsistent, or at times heterogeneous outcomes using these techniques have also highlighted need for novel strategies assessment their efficacy in ad hoc controlled clinical trials. Methods We here present double-blind, sham-controlled, single-center, randomized pilot trial involving participants having suffered unilateral (MCA) resulting paralysis contralateral upper limb. Patients will undergo 10-day regime (5 days week 2 consecutive weeks) newly designed high-definition transcranial direct current (HD-tDCS) protocol. Clinical evaluations (e.g., Fugl Meyer, NIHSS), computer-based assessments (visuo-motor adaptation AX-CPT attention tasks), electroencephalography (resting-state task-evoked EEG) be carried out 3 time points: (I) Baseline, (II) Post-tDCS, (III) Follow-up. The study consists four-arm comparing on recovery three active anodal tDCS conditions: ipsilesional DLPFC tDCS, contralesional cerebellar combined + sham intervention. Fugl-Meyer Assessment extremity (FMA-UE) is selected as primary outcome measure quantify In every session, receive min high-density (up 0.63 mA/ $${\mathrm{cm}}^{2}$$ cm 2 ) $${\mathrm{\pi cm}}^{2}$$ π electrodes. Electrode scalp positioning relative cortical surface (anodes cathodes) intensities are based biophysical optimization model distribution ensuring 0.25 V/m each chosen targets. Discussion Our gauge therapeutic accumulative sessions HD-tDCS improve limb dysfunctions presented by patients. parallel, we aim characterizing changes electroencephalographic (EEG) activity biomarkers effects identifying interactions between performance outcomes. work enrich our mechanistic understanding prefrontal contributions function its rehabilitation damage. Trial registration ClinicalTrials.gov NCT05329818. April 15, 2022.

Language: Английский

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