StrokeERICANCT06911671

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

A study testing Virtual Reality Interface + Cerebellar iTBS (c-iTBS) and Physical Therapy in people with Stroke and Stroke, Cardiovascular, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke, Stroke, Cardiovascular
What is being tested?: Virtual Reality Interface + Cerebellar iTBS (c-iTBS) and Physical Therapy
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteItaly
Study dates: 1 Apr 2025to 1 Oct 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Giacomo Koch, Prof. contact

0039 0651501181

g.koch@hsantalucia.it

Italy1 site, 1 recruiting

IRCCS Santa Lucia Foundation
Roma, Rome, 00179
Giacomo Koch, Prof., 0039 0651501181, g.koch@hsantalucia.it
Denise Berger, PhD, d.berger@hsantalucia.it
Recruiting

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions: Stroke, Stroke, Cardiovascular
Being tested: Virtual Reality Interface + Cerebellar iTBS (c-iTBS), Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS), Physical Therapy
Keywords: Virtual Reality, Brain Stimulation, Myoelectric Control, Transcranial Magnetic Stimulation, Cerebellar Stimulation, Motor Recovery, Tailored Assistance
Medical subject headings: Stroke, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality Interface + Cerebellar iTBS (c-iTBS)Device
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).
Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS)Device
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 TherapyOther
Passive mobilization and motor recruitment of impaired upper limb will be performed with the support of a physical therapist specialized in neurological rehabilitation.

Study groups in NCT06911671
Study group	Role	What they receive
EMG-VR real c-iTBS	Experimental	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. Receives: Device: Virtual Reality Interface + Cerebellar iTBS (c-iTBS)
EMG-VR sham c-iTBS	Sham comparator	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. Receives: Device: Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS)
Conventional Physical Therapy	Active comparator	Subjects will perform 12 sessions (~30 minutes, 3 times per weeks for 4 weeks) of physical therapy targeting on motor functionality of upper limb. Receives: Other: Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
Comprehensive clinical measurement tool of upper limb functions after stroke. Range score form 0 to 66 points, a higher score represents an improvement.
Measured: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.

Secondary outcomes (6)

Change in the Box and Block test (BBT)
BBT assesses the patient's manual dexterity. It is composed of a wooden box divided into two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of the box to the other of equal size within 60 seconds. The test is performed with both upper limbs separately to evaluate the manual dexterity of each arm individually.
Measured: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.
Change in modified Barthel Index (mBI) score
mBI is an ordinal scale that measures functional independence in the domains of personal care and mobility. Score range is from 0 (totally dependent) to 100 (independent).
Measured: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.
Change in the Nine Hole Peg Test (NHPT)
NHPT assesses the patient's fine manual dexterity and hand-eye coordination. It consists of a small board with nine holes and nine pegs. During the test, the patient is asked to place the pegs into the holes one by one and then remove them as quickly as possible. The total time to complete the task is recorded. The test is performed separately with each upper limb to evaluate the dexterity of both hands individually.
Measured: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.
Change in muscle activation patterns (EMG)
Task performance in the EMG-control mode will be quantified by the initial angle error and the fraction of unsuccessful trials during the task execution. To combine the initial angle error and the fraction of unsuccessful trials into a single performance index, a linear combination approach will be used. We will compare the initial, baseline performance measure of EMG index of the first session with the performance of the last session.
Measured: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.
Change in force-control
The change in force-control will be measured using EMG by analyzing the amplitude of the electromyographic signal (EMG) during the task. An increase in EMG amplitude indicates greater muscle activation, which correlates with improved muscle strength. We will compare the initial, baseline measure of force control of the first session with the measure of the last session.
Measured: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.
Change in Motor Evoked Potentials' (MEP) Amplitude
A single pulse transcranial magnetic stimulation will be applied to the primary motor cortex to produce a recordable motor-evoked potentials in contralateral muscles. The peak-to-peak amplitude of MEPs will be used to represent the cortico-spinal excitability. Both hemispheres will be investigated.
Measured: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20251 Oct 2027

First posted4 Apr 2025
Study start1 Apr 2025
Primary completion1 Aug 2027 (estimated)
Study completion1 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 45 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06911671
Sponsor's protocol ID: PROG.899
Other IDs: GR-2019-12370271
Acronym: ERICA
Status last verified: Mar 2025
First submitted: 3 Feb 2023
Last updated: 3 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 30476999

Interested in taking part?

Giacomo Koch, Prof.

0039 0651501181

g.koch@hsantalucia.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Innovative Upper Limb Stroke Rehabilitation Approach Combining Myoelectric Control Assistance in Virtual Reality and Cerebellar TBS Plasticity Enhancement
ClinicalTrials.gov ID: NCT06911671
Acronym / sponsor ID: ERICA / PROG.899
Conditions: Stroke, Stroke, Cardiovascular
Keywords: Virtual Reality, Brain Stimulation, Myoelectric Control, Transcranial Magnetic Stimulation, Cerebellar Stimulation, Motor Recovery, Tailored Assistance
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 45 participants (estimated)
Lead sponsor: I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
Study start: 1 Apr 2025 (actual)
Primary completion: 1 Aug 2027 (estimated)
Study completion: 1 Oct 2027 (estimated)
First posted: 4 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
EMG-VR real c-iTBS	Experimental	Device: Virtual Reality Interface + Cerebellar iTBS (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.
EMG-VR sham c-iTBS	Sham comparator	Device: Virtual Reality + Sham Cerebellar iTBS (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.
Conventional Physical Therapy	Active comparator	Other: Physical TherapySubjects will perform 12 sessions (~30 minutes, 3 times per weeks for 4 weeks) of physical therapy targeting on motor functionality of upper limb.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

History of seizures;
Treatment with Benzodiazepines, Baclofen;
Pregnancy status;
Intracranial metal implant;
Cardiac pace-maker;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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).	Device	EMG-VR real c-iTBS
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.	Device	EMG-VR sham c-iTBS
Physical TherapyPassive mobilization and motor recruitment of impaired upper limb will be performed with the support of a physical therapist specialized in neurological rehabilitation.	Other	Conventional Physical Therapy

Primary outcome

Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
Time frame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.
Comprehensive clinical measurement tool of upper limb functions after stroke. Range score form 0 to 66 points, a higher score represents an improvement.

6 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
Background: PubMed 15664172Huang 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.
Background: PubMed 16857577Hummel 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.
Background: PubMed 29775838Spampinato 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.
Background: PubMed 25283180Celnik P. Understanding and modulating motor learning with cerebellar stimulation. Cerebellum. 2015 Apr;14(2):171-4. doi: 10.1007/s12311-014-0607-y.
Background: PubMed 23884944Berger 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.
Background: PubMed 30476999Koch 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Giacomo Koch, Prof. contact

0039 0651501181

g.koch@hsantalucia.it

Giacomo Koch, Prof. study chair

IRCCS Santa Lucia Foundation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giacomo Koch, Prof. (0039 0651501181, g.koch@hsantalucia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE) (time frame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06911671, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.