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Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05713890
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IRCCS San Raffaele
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Maria A Rocca, MD
Principal Investigator Affiliation	IRCCS Ospedale San Raffaele
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

Experimental: VR-AOT

Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation

Active Comparator: VR-LO

Home-based landscape observation with virtual-reality for upper limb rehabilitation

Interventions

Other: - Home-based Action Observation Treatment with virtual-reality for upper limb rehabilitation

Observation of a VR scenario depicting multiple repetitions of a specific upper limb motor task belonging to typical activities of daily living, followed by mental imagination of the action observed and then by the execution of the same task, using objects provided in a kit. In each session, patients will watch 2 different videos and will perform the two corresponding actions. The time scheduled for observation, imagery and execution of each action will be of 5, 3, and 7 minutes, respectively, so that each session will last about 30 minutes. New actions, chosen from a dataset of 50 stimuli showing progressively increasing levels of difficulty, will be weekly administered on the basis of patient's degree of motor impairment, to involve different manual skills. 30 minutes sessions, 5 times a week for 3 consecutive weeks (15 sessions in total).

Other: - Home-based landscape observation with virtual-reality for upper limb rehabilitation

Observation of virtually explorable landscapes followed by rest with eyes closed without focusing on any thought in particular and then execution of the same actions requested to VR-AOT-group. In each session, patients will explore 2 different landscapes and perform 2 different actions. The time scheduled for observation, rest and action execution will be of 5, 3, and 7 minutes, respectively, so that each session will last about 30 minutes.New actions, chosen from a dataset of 50 stimuli showing progressively increasing levels of difficulty, will be weekly administered on the basis of patient's degree of motor impairment, to involve different manual skills. 30 minutes sessions, 5 times a week for 3 consecutive weeks (15 sessions in total).

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International Sites

IRCCS San Raffaele, Milan, Italy

Status

Recruiting

Address

IRCCS San Raffaele

Milan, , 20132

Site Contact

Massimo Filippi, MD

[email protected]

00390226433054

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