Home-based virtual reality treatment for arm rehabilitation in multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of home-based Action Observation Treatment (AOT) using virtual reality (VR) to enhance upper limb motor function in individuals with multiple sclerosis (MS). Participants will engage in either VR-AOT or VR-landscape observation for 15 sessions over three weeks. The study aims to assess improvements in motor performance and analyze brain changes through advanced MRI techniques. Additionally, it will explore the relationship between MRI findings and clinical outcomes to identify predictors of treatment efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS San Raffaele
  Milan, Milan, Italy Recruiting

Study contacts

• Principal investigator: Maria A Rocca, MD — IRCCS Ospedale San Raffaele
• Study coordinator: Maria A Rocca, MD
• Email: rocca.mara@hsr.it
• Phone: 0226433019

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.