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Sponsor: Fondazione Don Carlo Gnocchi ETS
Conditions: Multiple Sclerosis
Interventions: VRRS Khymeia, Usual care program, VRRS Khymeia plus active tDCS, VRRS Khymeia plus placebo tDCS
Countries: Italy
The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS, Khymeia) compared to usual care treatment for patients with MS at home. The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care training. The investigators will assess the effect of VRRS system on the quality of life, motor, and cognitive abilities. (Phase I) In the second phase of the present study we aim to evaluate the effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (lDLPFC) combined with VRRS compared to placebo tDCS stimulation combined with VRRS. The effects of the intervention patient-relevant outcomes will be assessed using a randomized controlled trial design with four groups. The investigators will assess the effect of VRRS system on patient-relevant outcomes motor, cognitive and participation. (Phase II)
Sex: ALL
Age: 25 Years to 70 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Confirmed diagnosis of Multiple Sclerosis (RR and SP) based on McDonald criteria * Education ≥ 8 ages * Italian mother language * Right-handedness * Use of corticosteroids for three months prior to the study, having and no acute exacerbations of symptoms within three months of the study. Exclusion Criteria: * Existence of visual acuity and acoustic perception problems, to prevent performance of VRRS activities * Relapses next to the time of enrolment (3 months) * EDSS \> 6.5.
- Milan, MI, Italy