NCT05713890 Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
| NCT ID | NCT05713890 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2026-09 |
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 60 participants in total. It began in 2023-11-02 with a primary completion date of 2026-09.
⚠ 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
Action Observation Treatment (AOT) is a rehabilitative strategy which has been proposed as a promising approach to improve motor performance in neurological conditions, including multiple sclerosis (MS). In this clinical trial, the investigators aim to explore the role of a home-based AOT with virtual reality (VR) in improving upper limb motor function in people with MS (PwMS). The objectives are: * To compare the effects of home-based VR-AOT versus VR-landscape observation (LO) on upper limb motor performance; * To measure brain network functional changes (functional plasticity) and structural variations of gray matter (GM) and white matter (WM) (structural plasticity) using advanced magnetic resonance imaging (MRI) techniques following VR-AOT and VR-LO; * To study the correlations between MRI changes and clinical improvements and the predictors of VR-AOT efficacy. All participants will undergo treatment sessions for 3 weeks (5 consecutive days/week, total=15 sessions lasting 30 minutes each). Those in the VR-AOT group will observe, imagine and execute two upper limb motor tasks in each session. Those in the VR-LO group will perform the same tasks, but they will observe inanimate landscapes beforehand instead.
Eligibility Criteria
Inclusion Criteria: * Age 18-65 years; * Diagnosis of MS according to 2017 revised McDonald criteria; * Ability to understand the purpose and risks of the study and provide signed informed consent; * Ability to remotely perform VR-AOT; * Right pre-morbid handedness (EHI\>50); * Muscle strength deficit involving the right upper limb (≥1 point decrease of MRC scale); * Presence of activity limitation of the right hand (need of adaptations, supervision or help by another person for the execution of daily living activities according to items 1-6 of the FIM); * EDSS score 2.0-7.0 (inclusive); * Cerebellar functional system score of the EDSS ≤1; * Baseline 9HPT score \>21 seconds and \<180 seconds. Exclusion Criteria: * MRI contraindications; * Significant visual deficits not allowing to observe VR stimuli; * Moderate to severe pain disturbances (VAS≥4); * Concomitant neuro-psychiatric or systemic diseases (other than MS); * Clinical relapses or steroid treatment in the past 3 months; * Modification of symptomatic treatment or botulin toxin injection in the upper limb in the past 3 months; * Stable disease-modifying treatment for MS for ≤6 months; * Rehabilitation treatment in the past 3 months.
Contact & Investigator
Maria A Rocca, MD
PRINCIPAL INVESTIGATOR
IRCCS Ospedale San Raffaele
Frequently Asked Questions
Who can join the NCT05713890 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05713890 currently recruiting?
Yes, NCT05713890 is actively recruiting participants. Contact the research team at rocca.mara@hsr.it for enrollment information.
Where is the NCT05713890 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05713890 clinical trial?
NCT05713890 is sponsored by IRCCS San Raffaele. The principal investigator is Maria A Rocca, MD at IRCCS Ospedale San Raffaele. The trial plans to enroll 60 participants.
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