Multisite Transcranial Direct Current Stimulation to Promote Hand Function Recovery After Stroke

Официальное название

Multisite Transcranial Direct Current Stimulation Targeting Motor Network by Mapping Electric Fields With Task-based fMRI to Promote Hand Function Recovery After Stroke

Обзор

A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond traditional stimulation which targeting only one region. It showed that the excitability following multisite HD-tDCS was more than double the increase following conventional tDCS. To consider the various lesion site of different stroke survivors. The electrode placements based on personalized lesion profiles and anatomical features can be determined using finite element modeling, with lesion profiles generated from fMRI and advanced algorithms calculating the current density to maximize the modulation effect. Combining motor network interaction and the new multisite electrode montage may further provide a potential to facilitate stroke recovery.

Вмешательства

• Устройство multisite HD-tDCS EMG-driven robot hand
  Multisite HD-tDCS will individual stimulation montages with robot hand training will be applied on chronic stroke survivors. In the multisite HD-tDCS group, 5-8 sintered Ag/AgCl ring electrodes will be placed based on the neuroimaging and computation modelling. The location of the electrodes will be identified by the individual brain activity in the primary motor cortex derived from tasked-based fMRI. The Finite Element Model (FEM) will be used to simulate the electric field distribution on indi
• Устройство Sham HD-tDCS EMG-driven robot hand
  Sham stimulation with robot hand training will be applied on chronic stroke survivors. After the sham stimulation, EMG-driven robot hand training will be conducted.

Первичные конечные точки

• Fugl-Meyer Assessment Upper Extremity [Срок оценки: 6-month after intervention]

Вторичные конечные точки (4)

• Action Research Arm Test [Срок оценки: 6-month after intervention]
• Magnetic Resonance Imaging (MRI) [Срок оценки: 6-month after intervention]
• Electroencephalography (EEG) [Срок оценки: 6-month after intervention]
• Electromyography (EMG) [Срок оценки: 6-month after intervention]

Критерии участия

Критерии включения

• first-ever stroke, the duration after stroke exceeds 12 months;
• mild to moderate upper extremity motor function deficit, determined by the Fugl-meyer assessment of upper extremity (FMAUE) scores between 15 and 53;
• detectable voluntary muscle sEMG signal from flexor digitorum (FD) and extensor digitorum (ED);
• scored below 3 in the Modified Ashworh Score (MAS) of FD and ED;
• sufficient cognitive function to follow the assessment and training instructions, determined by Mini Mental State Examination score of more than 21.

Критерии исключения

• history of epilepsy, or any other contradictions of brain stimulation;
• severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Department of Biomedical Engineering, The Chinese University of Hong Kong — Гонконг

Публикации

• Hu C, Ti CHE, Yuan K, Chen C, Khan A, Shi X, Chu WC, Tong RK. Effects of high-definition tDCS targeting individual motor hotspot with EMG-driven robotic hand training on upper extremity motor function: a pilot randomized controlled trial. J Neuroeng Rehabil. 2024 Sep 20;21(1):169. doi: 10.1186/s12984-024-01468-w. PMID 39304930

Идентификаторы

NCT: NCT05638464 · 2018.661

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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