Clinical trial NCT06911671: EMG Control Assistance Virtual Reality Interface Coupled With Cerebellar-iTBS for Arm Recovery After Stroke (ERICA)
Official title: Innovative Upper Limb Stroke Rehabilitation Approach Combining Myoelectric Control Assistance in Virtual Reality and Cerebellar TBS Plasticity Enhancement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Stroke, Cardiovascular
Keywords: Virtual Reality
Brain Stimulation
Myoelectric Control
Transcranial Magnetic Stimulation
Cerebellar Stimulation
Motor Recovery
Tailored Assistance
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that a myoelectric (EMG) controlled 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
timeFrame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks): T2.
measure: Change in the Action Research Arm Test (ARAT)
timeFrame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks): T2.
measure: Change in modified Barthel Index (mBI) score
timeFrame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks): T2.
measure: Change in muscle activation patterns (EMG)
timeFrame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks): T2.
measure: Change in force-control
timeFrame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks): T2.
measure: Change in Motor Evoked Potentials' (MEP) Amplitude
timeFrame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks): T2.
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS Santa Lucia Foundation
state: Rome
Study officials:
affiliation: IRCCS Santa Lucia Foundation
name: Giacomo Koch, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Celnik P. Understanding and modulating motor learning with cerebellar stimulation. Cerebellum. 2015 Apr;14(2):171-4. doi: 10.1007/s12311-014-0607-y.
citation: 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.
citation: 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.