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

January 30, 2026 updated by: I.R.C.C.S. Fondazione Santa Lucia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Rome
      • Roma, Rome, Italy, 00179
        • Recruiting
        • IRCCS Santa Lucia Foundation
        • Sub-Investigator:
          • Alex Martino Cinnera, MSc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea D'Avella, Prof.
        • Sub-Investigator:
          • Danny Spampinato, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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).
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.
Device: 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.
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.
Other: Physical Therapy
Passive mobilization and motor recruitment of impaired upper limb will be performed with the support of a physical therapist specialized in neurological rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Box and Block test (BBT)
Time Frame: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

Investigators

  • Study Chair: Giacomo Koch, Prof., IRCCS Santa Lucia Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROG.899
  • GR-2019-12370271 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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