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

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

Status: Enrolling

Conditions: Stroke, Cardiovascular; Stroke

Treatments: Other: Physical Therapy; Device: Virtual Reality Interface + Cerebellar iTBS (c-iTBS); Device: Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06911671

GR-2019-12370271 (Other Grant/Funding Number)

PROG.899

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

EMG-VR real c-iTBS

Experimental group

Description:

Subjects will perform 12 sessions (\~30 minutes, 3 times per weeks for 4 weeks) of assisted EMG control task (aEC) after real cerebellar intermittent theta burst stimulation (c-iTBS) for paretic upper limb.

Treatment:

Device: Virtual Reality Interface + Cerebellar iTBS (c-iTBS)

EMG-VR sham c-iTBS

Sham Comparator group

Description:

Subjects will perform 12 sessions (\~30 minute, 3 times per weeks for 4 weeks) of assisted EMG control task (aEC) after sham cerebellar intermittent theta burst stimulation (c-iTBS) for paretic upper limb.

Treatment:

Device: Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS)

Conventional Physical Therapy

Active Comparator group

Description:

Subjects will perform 12 sessions (\~30 minutes, 3 times per weeks for 4 weeks) of physical therapy targeting on motor functionality of upper limb.

Treatment:

Other: Physical Therapy