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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Santa Lucia Foundation
RECRUITING
Roma
Contact Information
Primary
Giacomo Koch, Prof.
g.koch@hsantalucia.it
0039 0651501181
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 45
Treatments
Experimental: EMG-VR real 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.
Sham_comparator: EMG-VR 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.
Active_comparator: Conventional Physical Therapy
Subjects will perform 12 sessions (\~30 minutes, 3 times per weeks for 4 weeks) of physical therapy targeting on motor functionality of upper limb.
Related Therapeutic Areas
Sponsors
Leads: I.R.C.C.S. Fondazione Santa Lucia

This content was sourced from clinicaltrials.gov