NCT06911671 EMG Control Assistance Virtual Reality Interface Coupled With Cerebellar-iTBS for Arm Recovery After Stroke (ERICA)
| NCT ID | NCT06911671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-04-01 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Giacomo Koch, Prof.
STUDY CHAIR
IRCCS Santa Lucia Foundation
Frequently Asked Questions
Who can join the NCT06911671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06911671 currently recruiting?
Yes, NCT06911671 is actively recruiting participants. Contact the research team at g.koch@hsantalucia.it for enrollment information.
Where is the NCT06911671 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06911671 clinical trial?
NCT06911671 is sponsored by I.R.C.C.S. Fondazione Santa Lucia. The principal investigator is Giacomo Koch, Prof. at IRCCS Santa Lucia Foundation. The trial plans to enroll 45 participants.
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