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Rehabilitative Protocols in Progressive Multiple Sclerosis Treated with Anti CD20 Monoclonal Antibodies

NCT06894940 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-03-25

No results posted yet for this study

Summary

Progressive multiple sclerosis (MS) patients have usually a worsening clinical course and it remains unclear if rehabilitation can indeed slow down the progression of the disease. Recently, clinical studies demonstrated that a treatment with monoclonal antibodies against B lymphocytes can have a positive effect on the progression of disability. Therefore now the investigators have, in this phase of the disease, a treatment that can impact the clinical course, even if the effect is not complete. The present study project has the aim to verify if, in progressive MS treated with monoclonal antibodies, a high technology rehabilitative protocol added to an intensive rehabilitation program is more effective on the motor recovery, in particular of the upper limb, as compared to an intensive traditional scheme of rehabilitation and to a passive treatment therapy, Moreover, the MRI functional reorganization of the central nervous system will be evaluated as well as the duration of the rehabilitative effect.

Conditions

Interventions

BEHAVIORAL

Active Comparator #1

task oriented rehabilitation

BEHAVIORAL

Placebo

passive rehabilitation

BEHAVIORAL

Experimental

rehabilitation with virtual reality

Sponsors & Collaborators

  • University of Genova

    collaborator OTHER

  • Consorzio per Valutazioni Biologiche e Farmacologiche

    collaborator OTHER

  • A.O.U. Città della Salute e della Scienza

    collaborator OTHER

  • University of Pavia

    lead OTHER

Principal Investigators

  • antonio nardone, prof · University of Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894940 on ClinicalTrials.gov