Personalized rehabilitation for early onset multiple sclerosis
Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis at High Risk of disEase Acitivity Through a Preventive personaLised and InnovAtive rehaBiLitation stratEgy. (RELIABLE)
NA · Fondazione Don Carlo Gnocchi Onlus · NCT06303024
This study is testing a personalized rehab program for people with early-stage relapsing-remitting multiple sclerosis to see if it can help slow down their disease progression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 1 site (Firenze) |
| Trial ID | NCT06303024 on ClinicalTrials.gov |
What this trial studies
This project focuses on an individualized rehabilitation approach for patients with early-stage relapsing-remitting multiple sclerosis (RRMS). It involves a comprehensive assessment of clinical, neuropsychological, and physical parameters to create a risk score that predicts disease progression. Patients will be evaluated at baseline and again after one year to stratify their risk and apply a tailored rehabilitation strategy aimed at reducing disease activity. The study is multicentric and includes collaboration between multiple medical centers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of relapsing-remitting multiple sclerosis and a disease duration of less than 5 years.
Not a fit: Patients with significant psychiatric comorbidities or other non-MS related impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management and outcomes for patients with early onset multiple sclerosis.
How similar studies have performed: While individualized rehabilitation approaches have been explored, this specific method of risk stratification and intervention in early RRMS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of RRMS based on the 2017 McDonald criteria; * age ≥ 18 years; * EDSS ≤ 2.0; * disease duration ≤ 5 years; * verification of MS subtype, * duration of disease and EDSS will be accomplished by obtaining a signed consent form for the release of medical information from the treating neurologist. Exclusion Criteria: * history of relevant psychiatric comorbidities. * Severely depressed subjects assessed through the Beck Depression Inventory (scores ≥ 29); * relapses or corticosteroid treatment in the 30 days before inclusion; * history of substance abuse; * presence of non-MS related physical or cognitive impairment that could make the patient unable to complete the study assessments.
Where this trial is running
Firenze
- IRCCS Fondazione Don Carlo Gnocchi ONLUS — Firenze, Italy (RECRUITING)
Study contacts
- Study coordinator: Maria Pia Amato, Prof
- Email: mpamato@dongnocchi.it
- Phone: 0557947836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Relapsing-Remitting