CompletedPhase 2Progressive MSNCT06894940

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Experimental

Compared with

  • Active Comparator #1

Placebo or sham

  • Placebo

What it measured

Main measures

  • The Primary endpoint is the improvement in the distal motility of the upper limb evaluated with the Nine Hole Peg test.

    baseline and after 2 and 5 months

    Arm and hand function

Other measures (1)

  • Patients will be evaluated at baseline, at the end of the treatment period and after 3 months with the the action research arm test (ARAT).

    at baseline, after 2 and 5 months

    Arm and hand function

Who could take part

Progressive MS · 25 to 65

Inclusion criteria: * age 25-65 years; * right-handed * progressive active form of MS treated with anti B monoclonal antibodies, Ocrelizumab or Rituximab since at least 6 months. * EDSS 3-7. * absence of relevant cognitive deficiency, as evaluated with Brief International Cognitive Assessment for MS (Bicams) °absence of visual or audio deficit disorders. Exclusion criteria: * history of a cardiovascular disorder or any other disease that can hamper the active participation to the research project. * Contraindication to perform MRI exams

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jun 2021

    2. Main results due

      Nov 2024

    3. Finished

      Nov 2024

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