Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic Mirror Therapy for Post-Stroke Upper Limb Motor Function Disorder

Официальное название

A Prospective, Randomized, Parallel-Controlled Clinical Study Protocol of Non-Invasive Brain Computer Interface Robot Based on Mirror Rehabilitation Theory in the Treatment of Upper Limb Motor Function Disorder After Stroke

Обзор

This study aims to utilize non-invasive brain-computer interface technology in conjunction with mirror therapy to design a new paradigm for rehabilitation robots to induce compensatory movements on the healthy side in stroke patients, evaluate the potential rehabilitation value of this paradigm for patients with severely impaired motor areas on the affected side, explore the neural rehabilitation compensation mechanism, and provide more personalized rehabilitation treatment strategies for patients with post-stroke motor dysfunction.

Подробное описание

This is a prospective, single-center, open-label, outcome-assessor-blinded, randomized, parallel-controlled clinical study initiated by investigators. Based on the post-stroke compensatory model theory, this study innovatively combines brain-computer interface and mirror robot technology to build a dynamic closed-loop feedback system. Using the contralesional compensatory activation mechanism and a designed robot training paradigm, it explores the efficacy of the intervention in improving upper limb motor function and its underlying neural recovery mechanisms.

Вмешательства

• Устройство Brain computer interface-robotic mirror therapy
  BCI-RMT was performed by acquiring electroencephalographic signals from the unaffected hemisphere via a brain-computer interface, analyzing the signals with artificial intelligence, and finally delivering assisted motor function rehabilitation for the affected upper extremity via an intelligent exoskeleton training robot.

Первичные конечные точки

• Changes in Fugl-Meyer Assessment of the Upper Extremity for the affected upper limb at the forth week after enrollment. [Срок оценки: 4 weeks]

Вторичные конечные точки (7)

• The improvement in the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) for the affected upper limb at the eighth week after enrollment. [Срок оценки: 8 weeks]
• Changes in neural conduction pathways at the forth week after enrollment. [Срок оценки: 4 weeks]
• Differences in changes of electroencephalographic (EEG) signals at the forth week after enrollment. [Срок оценки: 4 weeks]
• Improvements in the Wolf Motor Function Test of the affected upper extremity at the forth week and the eighth week after enrollment. [Срок оценки: 4 weeks and 8 weeks]
• Improvements in Modified Barthel Index (MBI) scores at the forth week and the eighth week after enrollment. [Срок оценки: 4 weeks and 8 weeks]
• Changes in Modified Ashworth Scale (MAS) scores at the forth week and the eighth week after enrollment. [Срок оценки: 4 weeks and 8 weeks]
• Changes in Montreal Cognitive Assessment (MoCA) scores at the forth week and the eighth week after enrollment. [Срок оценки: 4 weeks and 8 weeks]

Критерии участия

Критерии включения

• Aged 30 to 80 years
• Patients with unilateral upper limb motor dysfunction caused by primary ischemic/hemorrhagic stroke within 1 to 6 months prior to enrollment
• Cerebral magnetic resonance diffusion-weighted imaging (DWI) at the time of onset indicating that the stroke lesion is limited to the unilateral basal ganglia region
• Modified Rankin Scale (mRS) score of 0 to 2 before stroke onset
• Fugl-Meyer Motor Function Assessment of Upper Extremities (FMA-UE) score of 10 to 42
• Montreal Cognitive Assessment (MoCA) score > 18
• Fugl-Meyer Balance Assessment score > 6
• Normal binocular visual acuity or corrected visual acuity
• Normal hearing and intact verbal comprehension ability
• Provided written informed consent

Критерии исключения

• Patients with other severe cardiovascular and cerebrovascular diseases and unstable vital signs
• Patients with motor dysfunction caused by other etiologies, such as amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, etc.
• Patients with severe diseases of the lungs, liver, kidneys and other vital organs
• Patients with limb movement impairment caused by diseases such as fractures and arthritis
• Modified Ashworth Scale (MAS) score > 3
• Patients unable to understand and cooperate with limb rehabilitation training due to factors such as severe aphasia
• Presence of severe visual field defects or visual impairments (e.g., hemianopsia, hemispatial neglect, etc.
• History of previous stroke
• A history of severe motor injury and/or surgical intervention of the affected upper limb, such as muscle tear, tendon rupture, rhabdomyolysis
• Life expectancy of less than 1 year due to the underlying disease
• Undergoing major surgery within the past 30 days or planning to undergo major surgery within the next 90 days
• Pregnant or lactating women
• History of drug or alcohol abuse, head trauma or central nervous system infection; current use of cognition-impairing medications such as psychoactive or sedative drugs
• With definite psychiatric and psychological disorders, such as depression, anxiety disorder, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorder, consciousness disorder, etc.
• Having implanted electronic devices in the body that interfere with magnetic resonance imaging (MRI), such as cochlear implants, cardiac pacemakers/defibrillators, drug delivery pumps
• Poor compliance of the subject, their family members and caregivers, or inability to complete at least 12 months of follow-up as required by the study
• Having been enrolled in other clinical studies that conflict with this study
• Judged by the Indication Evaluation Committee as ineligible for or not falling within the scope of this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital, Capital Medical University — Пекин

Публикации

• Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8. doi: 10.1001/archneur.61.12.1844. PMID 15596603
• Mohapatra S, Harrington R, Chan E, Dromerick AW, Breceda EY, Harris-Love M. Role of contralesional hemisphere in paretic arm reaching in patients with severe arm paresis due to stroke: A preliminary report. Neurosci Lett. 2016 Mar 23;617:52-8. doi: 10.1016/j.neulet.2016.02.004. Epub 2016 Feb 9. PMID 26872851
• Kaiser V, Daly I, Pichiorri F, Mattia D, Muller-Putz GR, Neuper C. Relationship between electrical brain responses to motor imagery and motor impairment in stroke. Stroke. 2012 Oct;43(10):2735-40. doi: 10.1161/STROKEAHA.112.665489. Epub 2012 Aug 14. PMID 22895995
• Ma ZZ, Wu JJ, Cao Z, Hua XY, Zheng MX, Xing XX, Ma J, Xu JG. Motor imagery-based brain-computer interface rehabilitation programs enhance upper extremity performance and cortical activation in stroke patients. J Neuroeng Rehabil. 2024 May 29;21(1):91. doi: 10.1186/s12984-024-01387-w. PMID 38812014
• Liu X, Zhang W, Li W, Zhang S, Lv P, Yin Y. Effects of motor imagery based brain-computer interface on upper limb function and attention in stroke patients with hemiplegia: a randomized controlled trial. BMC Neurol. 2023 Mar 31;23(1):136. doi: 10.1186/s12883-023-03150-5. PMID 37003976
• Kruse A, Suica Z, Taeymans J, Schuster-Amft C. Effect of brain-computer interface training based on non-invasive electroencephalography using motor imagery on functional recovery after stroke - a systematic review and meta-analysis. BMC Neurol. 2020 Oct 22;20(1):385. doi: 10.1186/s12883-020-01960-5. PMID 33092554
• Martini ML, Oermann EK, Opie NL, Panov F, Oxley T, Yaeger K. Sensor Modalities for Brain-Computer Interface Technology: A Comprehensive Literature Review. Neurosurgery. 2020 Feb 1;86(2):E108-E117. doi: 10.1093/neuros/nyz286. PMID 31361011
• Colucci A, Vermehren M, Cavallo A, Angerhofer C, Peekhaus N, Zollo L, Kim WS, Paik NJ, Soekadar SR. Brain-Computer Interface-Controlled Exoskeletons in Clinical Neurorehabilitation: Ready or Not? Neurorehabil Neural Repair. 2022 Dec;36(12):747-756. doi: 10.1177/15459683221138751. Epub 2022 Nov 25. PMID 36426541

Идентификаторы

NCT: NCT07553416 · BJXZ-CY-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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