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New treatment option for Multiple Sclerosis
Official title Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis
ClinicalTrials.gov ID: NCT05713890
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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);
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.