Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303024
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-04
Brief Title:
Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELIABLE
Brief Summary:
Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission RR MS This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice This risk score will be obtained from an extensive neuropsychological psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-upThe risk score will allow a better stratification of patients risk of disease worseningprogression and the application of a preventive and personalized strategy
Detailed Description:
This is a multicentric no-profit pilot study composed by two phases The objective of the first phase is to create a multi-factorial assessment and prognostic profiling into different risk categories integrating different techniques in a common evaluation approach MS patients referred to the MS Centers of Careggi University Hospital and the Sheba Medical Centre in Tel-Aviv will be recruit and assess at baseline and 12-months follow-up using a comprehensive approach The patients will undergo an advanced motor performance evaluation neuropsychological assessment and a brain MRI scan to evaluate the presence of newenlarging T2 lesions new gadolinium-positive lesions and volumetric analyses eg total brain volume grey matter volume white matter volume T2 lesions volume normalized thalamic and hippocampal volume Data collected from the comprehensive baseline and 12 months assessment will be used to generate a risk score for disease worsening in the short-term classifying the patients into lowmild moderate or high risk All the variables significantly associated with disease activity will be combined in the risk scoreThe objectives of II Phase are to apply the previously obtained risk score on a novel cohort using the same inclusionexclusion criteria to evaluate the impact of a combined rehabilitation approach in reducing the proportion of patients with disease activityThe risk score obtained from follow-up data of the test cohort applied to the newly recruited patients Only patients with moderate to high risk of worsening in this new cohort will be included in the rehabilitation program The included patients will receive an innovative and personalized rehabilitation approach including counselling on lifestyle habits an aerobic moderate to high-intensity physical training and a computerized cognitive rehabilitation programThe efficacy of the rehabilitation approach will be then evaluated by comparing patients included in this cohort with patients in the same risk groups included in the phase 1 cohort Across Phases of the study Uppsala University partner will conduct a surveillance and will consider Social and ethical aspects of the integrated rehabilitation approach Personalized preventive interventions and tailored risk information may raise pressing ethical issues that need careful reflection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None