EMG Control Assistance Virtual Reality Interface Coupled With Cerebellar-iTBS for Arm Recovery After Stroke (ERICA)
NCT ID: NCT06911671
Last Updated: 2025-11-21
Study Results
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Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-04-01
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EMG-VR real c-iTBS
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.
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).
EMG-VR sham c-iTBS
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.
Vitual 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.
Conventional Physical Therapy
Subjects will perform 12 sessions (\~30 minutes, 3 times per weeks for 4 weeks) of physical therapy targeting on motor functionality of upper limb.
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.
Interventions
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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).
Vitual 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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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I.R.C.C.S. Fondazione Santa Lucia
OTHER
Responsible Party
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Principal Investigators
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Giacomo Koch, Prof.
Role: STUDY_CHAIR
IRCCS Santa Lucia Foundation
Locations
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IRCCS Santa Lucia Foundation
Roma, Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Celnik P. Understanding and modulating motor learning with cerebellar stimulation. Cerebellum. 2015 Apr;14(2):171-4. doi: 10.1007/s12311-014-0607-y.
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.
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.
Other Identifiers
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GR-2019-12370271
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PROG.899
Identifier Type: -
Identifier Source: org_study_id
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