EMG-controlled virtual hand with cerebellar magnetic stimulation to improve arm recovery after stroke
Official title: Innovative Upper Limb Stroke Rehabilitation Approach Combining Myoelectric Control Assistance in Virtual Reality and Cerebellar TBS Plasticity Enhancement
Run by LIFE - Research and Care Institute - Santa Lucia IRCCS · NCT06911671 · Data updated 2026-11-12
This program will test whether an EMG-controlled virtual reality hand combined with brief cerebellar magnetic stimulation helps adults (18–79) with mild-to-moderate upper-limb weakness after a first ischemic stroke regain reaching ability and arm function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | LIFE - Research and Care Institute - Santa Lucia IRCCS Academic / other |
| Locations | 1 site (Roma, Rome) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | August 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT06911671 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18–79 with a first-ever ischemic stroke and mild-to-moderate upper-limb motor impairment (Fugl-Meyer <56) without visuospatial, cognitive, or attention deficits.
✕Probably not a fit
Patients with severe paralysis, a history of seizures, intracranial metal implants or pacemakers, pregnancy, current use of benzodiazepines or baclofen, significant upper-limb orthopedic or pain limitations, or other neurologic/psychiatric conditions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants use an EMG-controlled interface that moves a virtual hand according to their muscle activity, with the system providing assistive visual feedback to correct dysfunctional muscle patterns so reaching movements can be performed. Assistance is gradually reduced to make errors more salient and drive adaptation of the patient’s own muscle activity. Some participants receive intermittent theta-burst stimulation to the cerebellum (c-iTBS) intended to boost cerebellar excitability and support motor learning, while others receive sham stimulation or standard physical therapy. Primary outcomes focus on upper-limb motor recovery measures such as the Fugl-Meyer score and functional reaching ability.
Why it matters
Potential benefit: If successful, this approach could speed and improve recovery of reaching and overall arm function beyond standard therapy.
How similar studies have gone: Previous small trials suggest EMG-guided VR and transcranial theta-burst stimulation can each support motor relearning, but combining EMG-assistive VR with cerebellar iTBS is relatively novel and not yet widely tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
IRCCS Santa Lucia Foundation
Roma, Rome, Italy Recruiting
Study contacts
- Study coordinator: Giacomo Koch, Prof.
- Email: g.koch@hsantalucia.it
- Phone: 0039 0651501181
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.