An interventional study of VRRS Khymeia and Usual care program in Multiple Sclerosis, sponsored by Fondazione Don Carlo Gnocchi Onlus. Active, not recruiting at 1 site in Italy. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
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Among 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus — 7 open to participants now, 8 under way, none of them phase 3. Multiple Sclerosis · Fondazione Don Carlo Gnocchi Onlus.
Among the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus, this one is the 4th largest by enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2018, is one of 20 with no phase, and was the 9th registered.
3,269 studies on the registry are indexed under Multiple Sclerosis; 663 are open to participants now.
Browse Multiple Sclerosis studies →7 of the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus are open now, in 1 country. Recruiting first, the newest first:
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 25–85
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–85
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–60 · Healthy volunteers
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18+
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–70
By country, each count listing its studies:
Of the 431 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 212 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 25 Years to 70 Years · all sexes · no healthy volunteers.
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25 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2018.
This study's enrollment of 136 is above the median of 50 across 2,205 interventional studies indexed under Multiple Sclerosis.
Median enrollment 48 across the 21 interventional studies, 142 across the 4 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
1 of the studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05493514Fondazione Don Carlo Gnocchi OnlusClinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System | 2027-04-01 |
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Among the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group will receive a kit home-based (a tablet home, an exercise equipment, access to a daily individualized training program). The exercise program will be remotely charged by therapist on the patient's computer. Each patient's performed session will be reviewed remotely by the therapist.
Behavioral: VRRS Khymeia
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
Behavioral: Usual care program
The group will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training
Behavioral: VRRS Khymeia plus active tDCS
The group will receive 5 sessions of an individualized home-based VRRS training combined with placebo tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training
Behavioral: VRRS Khymeia plus placebo tDCS
Participants will receive an individualized exercise program set up by the therapist. The intervention applied to the experimental group will consist of 30 sessions of Khymeia VRRS training distributed in five sessions for week, each lasting 45 minutes. Each session is constructed by alternating physical with cognitive activities. The sessions will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training. The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training. The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.
Change in measure of quality of life
Quality of life will be measured by 54-item Multiple Sclerosis Quality of Life (MSQOL-54) questionnaire There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In addition, there are 12 subscales: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. There are also two single-item measures: satisfaction with sexual function and change in health. Administration forms and scoring instructions can be downloaded (https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/MSQOL54_995.pdf ). Higher values represent a better outcome
Time frame: Baseline up to 6 weeks and 6 months
Change in balance
Mini-Balance Evalutation System (mini-BES) Test
Time frame: Baseline up to 6 weeks and 6 months
Change in gait
12-item Multiple Sclerosis Walking Scale
Time frame: Baseline up to 6 weeks and 6 months
Change gross manual dexterity
Box and Block Test
Time frame: Baseline up to 6 weeks and 6 months
Change in global cognitive status
Montreal Cognitive Assessment (MoCA) test
Time frame: Baseline up to 6 weeks and 6 months
Change cognitive status
Symbol Digit Modalities Test (Form Brief Repeatable Battery of Neuropsychological Tests )
Time frame: Baseline up to 6 weeks and 6 months
Change in fatigue
Fatigue Severity Scale A questionnaire with 9 items (questions) Grading of each FSS item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items Higher values represent a worse outcome
Time frame: Baseline up to 6 weeks and 6 months
Change in Emotional Traits
The Regulatory Emotional Self-Efficacy (RESE) scale The RESE scale assesses self-efficacy in expressing positive emotions and self-efficacy in managing negative emotions. With this scale, participants rate (ranging from 1 \[not well at all\] to 5 \[very well\]) their capability to manage their emotional life. RESE scale consists of 12 items and are calculated 3 scores: 1) self-efficacy in expressing positive emotions (POS) score; 2)self-efficacy in managing negative emotions (NEG) score; 3)self-efficacy in managing despondency/distress (DES) score Higher values within each score represent a better outcome
Time frame: Baseline up to 6 weeks and 6 months
Change in Behavioral (depression)
Beck Depression Inventory
Time frame: Baseline up to 6 weeks and 6 months
Change in Behavioral (anxiety)
State-trait anxiety inventory
Time frame: Baseline up to 6 weeks and 6 months
Plan to share: Undecided
Ran from Feb 2018 to primary completion in Dec 2018, 10 months.
Of 849 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 10 months is below that.
Counting every sponsor, half of 871 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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