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

An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis: a Clinical and Neuroimaging Study

This study tests if using virtual reality at home can help people with multiple sclerosis improve their arm movement and function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: IRCCS San Raffaele (other)
• Locations: 1 site (Milan, Milan)
• Trial ID: NCT05713890 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of multiple sclerosis and specific motor function limitations in the right upper limb.

Not a fit: Patients with significant visual deficits, severe pain, or other neuro-psychiatric conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for patients with multiple sclerosis.

How similar studies have performed: Other studies have shown promise in using virtual reality for rehabilitation in neurological conditions, suggesting potential success for this approach.

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.

Where this trial is running

Milan, Milan

• 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

Conditions: Multiple Sclerosis