Brain-computer Interface (BCI)-Guided Upper Limb Neurorehabilitation for Acute Stroke With the recoveriX System
Stroke is a leading cause of neurological disability and upper limb impairment. While conventional rehabilitation options exist, brain-computer interface (BCI)-based neurorehabilitation has emerged as a promising approach that records and decodes neural signals to drive rehabilitation devices or functional electrical stimulation. By re-coupling cortical motor intent to limb movement, BCI systems restore closed-loop neurofeedback and facilitate neuroplasticity through residual neural pathways. Motor intent is detected non-invasively via scalp electroencephalography (EEG), using characteristic changes in mu and beta rhythm activity known as event-related desynchronisation (ERD). This study aims to investigate how these electrophysiological signals change over time following stroke and their implications for BCI-based rehabilitation.
Обзор исследования
Статус
Условия
Подробное описание
Stroke is a leading cause of neurological disability, resulting in significant upper limb impairment. Current rehabilitation approaches include conventional occupational therapy, constraint-induced movement therapy, and robot-assisted therapy. Brain-computer interface (BCI)-based neurorehabilitation has emerged as a promising addition, whereby neural signals are recorded, decoded to determine motor intent, and used to drive external devices or functional electrical stimulation of the patient's own muscles.
A key mechanism underlying BCI-based rehabilitation is the restoration of closed-loop neurofeedback. Conventional rehabilitation lacks a direct link between a patient's volitional intent and limb movement. BCI systems address this by re-coupling cortical motor signals to end-effector activity, bypassing lesioned neural pathways and facilitating Hebbian neuroplasticity. Sensory feedback from limb movement further reinforces this closed loop, promoting recovery of motor function through residual and alternative neural pathways.
Motor intent is measured non-invasively using scalp electroencephalography (EEG), which captures oscillatory brain activity - particularly the mu (8-13 Hz) and beta (13-30 Hz) rhythms - that correlate with motor preparation and execution. During movement intent, characteristic reductions in these rhythms, known as event-related desynchronisation (ERD), can be detected algorithmically and used to control rehabilitation devices. Following stroke, these electrophysiological signals are known to be altered, though how they evolve over time remains an open question that this study aims to address.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Xin Yi Lim
- Номер телефона: 63596312
- Электронная почта: xin.yi.lim1@nhghealth.com.sg
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adults between age 21 to 80 years with hemorrhagic or ischemic stroke
- Stroke onset within 2-12 weeks
- Any demonstrated voluntary finger flexion or finger extension Oxford Medical Research Council (MRC) grade 0 to 4 (total 5)
- Montreal Cognitive Assessment (MoCA) > 20
- Ability to understand written and spoken instructions, as well as stable medical and neurological status.
Exclusion Criteria:
- Presence of previous diagnosis of stroke
- Implanted pacemaker or continuous infusion pump
- History of seizures or past history of epilepsy
- Recent neurosurgery
- Medical instability deemed by study team
- Severe blindness
- Anticipated life expectancy <6 months
- Hemodialysis
- Inability to obey 1-step commands
- Severe aphasia, or dysarthria
- Severe arm/hand pain (Visual Analog Scale >4/10) or severe hemi anesthesia or spasticity in the paretic arm (modified Ashworth scale MAS >2, total 4)
- Fixed shoulder or finger joint contractures, active arthritis in any upper limb joint
- Inability to tolerate upright supported sitting posture for at least 45 minutes
- Disorders of consciousness or altered arousal states precluding active participation in the task.
- Pregnant women will be excluded from the study as the safety of FES (electrical stimulations) on foetus is unclear.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)
|
Participants will undergo BCI-based neurorehabilitation using the FDA-approved recoveriX system, comprising a wet-electrode EEG cap, EEG signal processing software, and a functional electrical stimulator (FES). Treatment consists of up to 12 sessions over 3 to 4 weeks (2-3 sessions/week), supervised by a trained study team member, alongside usual inpatient rehabilitation. Each session involves motor imagery (MI) of finger extension across 3 blocks of 80 trials (240 total). Each trial begins with a 2-second baseline, followed by an auditory and visual cue to imagine finger extension for 5 seconds. If MI is detected (assessed every 200 ms), FES is delivered to the finger extensors (50 Hz, 300 µs pulse width), titrated to produce movement without pain. Real-time feedback is provided, and a session report is generated for review. Within 2 hours of each session, participants undergo 45 minutes of conventional standard-of-care occupational therapy. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Functional Independence Measure (FIM)
Временное ограничение: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
An 18-item clinical assessment tool used to measure a patient's level of disability and determine how much assistance they require to perform basic activities of daily living. Minimum score: 18 (Patient requires total assistance for all 18 tasks), maximum score: Maximum score: 126 (Patient is completely independent in all 18 tasks), with higher score indicating better function. |
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
|
Fugl-Meyer Motor Assessment (FMA) scale
Временное ограничение: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function |
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
|
Action Research Arm Test (ARAT) Score
Временное ограничение: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function. |
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
|
Stroke Impact Scale v3.0
Временное ограничение: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
A patient-reported questionnaire used to evaluate how a stroke impacts health and quality of life. Patients rate how difficult tasks are on a 5-point Likert scale (1 = "could not do it at all" to 5 = "not difficult at all"). Scores for each domain are then standardized to range from 0 to 100, with higher scores indicating better functioning and a higher quality of life. An additional visual scale asks patients to estimate their overall stroke recovery from 0 (no recovery) to 100 (full recovery). |
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
|
EQ-5D-5L
Временное ограничение: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
EQ-5D-5L is a standardized, patient-reported questionnaire used globally to evaluate health-related quality of life. It measures 5 dimensions of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each area features 5 severity levels, from "no problems" to "extreme problems". |
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Yu Tung Lo, National Neuroscience Institute
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ECOS ref: 2024-3186
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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