RecruitingNot ApplicableNCT06911671

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

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

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

Enrollment

45 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke Stroke, Cardiovascular

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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.

Exclusion Criteria8

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.

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Interventions

DEVICEVirtual 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).

DEVICEVirtual 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.

OTHERPhysical Therapy

Passive mobilization and motor recruitment of impaired upper limb will be performed with the support of a physical therapist specialized in neurological rehabilitation.