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

Study acronym: ERICA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: 7 to 1
    • Interventions: Physical Therapy (Other), Virtual Reality Interface + Cerebellar iTBS (c-iTBS) (Device), Vitual Reality + Sham Cerebellar iTBS (sham… to Physical Therapy (Other), Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS) (Device), Virtual Reality Interface + Cerebellar iTBS…
    • Secondary endpoints expanded, about 39 words
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 6 to 7
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06911671
Lead Sponsor I.R.C.C.S. Fondazione Santa Lucia
Conditions
(from sponsor)		 Stroke, Stroke, Cardiovascular
Related terms Myocardial Infarction, Stroke
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov