EMG Control Assistance Virtual Reality Interface Coupled With Cerebellar-iTBS for Arm Recovery After Stroke (ERICA)

Официальное название

Innovative Upper Limb Stroke Rehabilitation Approach Combining Myoelectric Control Assistance in Virtual Reality and Cerebellar TBS Plasticity Enhancement

Обзор

The investigators hypothesize that a myoelectric (EMG) controlled virtual reality (VR) interface allows for effective upper limb motor recovery of stroke patients. EMG control offers the possibility to alter visual feedback according to the recorded muscle activity in real-time. By manipulating the motion of a virtual hand associated with the recorded muscle patterns, assistance can be provided to stroke patients by correcting the error between the actual (dysfunctional) and a reference (functional) muscle pattern. Thus, through such an assistive EMG control algorithm, patients will be able to perform reaching movements with the virtual hand despite their motor impairment. By gradually reducing assistance, it is hypothesized that the salient error in the task space provided as visual feedback will systematically change the muscle patterns, thereby driving adaptation of the dysfunctional muscle patterns, enhancing motor recovery. Moreover, due to its relevant role in motor learning, it is expected that cerebellar stimulation will favor the underlying processes of adapting cerebello-cortical plasticity involved in motor learning. Therefore, it is hypothesized that an assistive EMG control algorithm in combination with cerebellar transcranial magnetic stimulation will further enhance upper limb recovery.

Подробное описание

Theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression. Theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability.

Вмешательства

• Устройство Virtual Reality Interface + Cerebellar iTBS (c-iTBS)
  Subjects will sit in a chair with their forearm inserted in a splint attached to a force transducer. The subjects' view of their hand will be occluded by a mirror displaying the virtual scene. EMGs from arm and shoulder muscles will be recorded by surface EMG electrodes. Subjects will displace a virtual handle according to either the forces recorded by the force transducer or forces estimated from the recorded EMGs (EMG control).
• Устройство Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS)
  c-iTBS will be carried out using Magstim Rapid magnetic biphasic stimulator. Twenty 2-s trains of three-pulse bursts at 50 Hz repeated every 200 ms with an inter-train interval of 10 s, for a total of 190 s will be applied over the contralesional lateral cerebellum. The coil will be positioned tangentially to the scalp for real and 90° angled for sham c-iTBS.
• Другое Physical Therapy
  Passive mobilization and motor recruitment of impaired upper limb will be performed with the support of a physical therapist specialized in neurological rehabilitation.

Первичные конечные точки

• Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE) [Срок оценки: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.]

Вторичные конечные точки (6)

• Change in the Box and Block test (BBT) [Срок оценки: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.]
• Change in modified Barthel Index (mBI) score [Срок оценки: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.]
• Change in the Nine Hole Peg Test (NHPT) [Срок оценки: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.]
• Change in muscle activation patterns (EMG) [Срок оценки: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.]
• Change in force-control [Срок оценки: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.]
• Change in Motor Evoked Potentials' (MEP) Amplitude [Срок оценки: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.]

Критерии участия

Критерии включения

• First ever ischemic stroke with mild to moderate motor impairment of upper limb;
• Left or right sub-cortical or cortical lesion of the middle cerebral artery;
• Age>18, <80 years;
• No visuospatial, cognitive, or attention deficits;
• Fugl-Meyer score<56.

Критерии исключения

• History of seizures;
• Treatment with Benzodiazepines, Baclofen;
• Pregnancy status;
• Intracranial metal implant;
• Cardiac pace-maker;
• Orthopedic upper limb limitation;
• Upper limb pain;
• Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the 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

Четверное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS Santa Lucia Foundation — Roma

Публикации

• Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. PMID 15664172
• Hummel FC, Cohen LG. Non-invasive brain stimulation: a new strategy to improve neurorehabilitation after stroke? Lancet Neurol. 2006 Aug;5(8):708-12. doi: 10.1016/S1474-4422(06)70525-7. PMID 16857577
• Spampinato D, Celnik P. Deconstructing skill learning and its physiological mechanisms. Cortex. 2018 Jul;104:90-102. doi: 10.1016/j.cortex.2018.03.017. Epub 2018 Mar 27. PMID 29775838
• Celnik P. Understanding and modulating motor learning with cerebellar stimulation. Cerebellum. 2015 Apr;14(2):171-4. doi: 10.1007/s12311-014-0607-y. PMID 25283180
• Berger DJ, Gentner R, Edmunds T, Pai DK, d'Avella A. Differences in adaptation rates after virtual surgeries provide direct evidence for modularity. J Neurosci. 2013 Jul 24;33(30):12384-94. doi: 10.1523/JNEUROSCI.0122-13.2013. PMID 23884944
• Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639. PMID 30476999

Идентификаторы

NCT: NCT06911671 · PROG.899 · GR-2019-12370271

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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