OngoingPhase 2MS (type not specified)2012-000287-17

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • 1. To establish the clinical benefit of rehab on right upper limb function and to identify imaging markers of clinical improvements. Rehab clinical benefits will be assessed using 9-hole peg test. MRI markers of clinical improvements will be identified through correlations between functional changes in patterns of brain activations and performance improvements.

    Disability progressionMRI lesionsArm and hand function

Other measures (1)

  • Indirect clinical benefit of rehab in association with drug. This additional benefit will be assessed using quality of life (MSQoL-54), and mood and anxiety (Beck Depression Inventory Scale and STAI) tests.

    Mood and sleepQuality of life (reported by participants)

Who could take part

MS (type not specified)

Inclusion: Right handed Multiple Sclerosis patients without relapses in the previous year and, if under pharmacological treatment, with a stable dose regimen for at least 3 months. Patients will be included if they present with a right hand dexterity impairment (average of 2 performances in 9-hole peg test: >30 seconds). Exclusion: Rehab in the previous 6 months; significant cognitive deficit that may prevent engagement in the study; contraindications to MRI scan; allergy to the drug or the eccipients; any relevant pathology that contraindicate drug intake.

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

About this trial

In the sponsor's words

1. To investigate the brain correlates of rehabilitation (rehab)-related clinical benefits on upper limb function in Multiple Sclerosis (MS) and to qualify imaging markers associated with performance improvements. Patterns of movement control can be adaptively driven by rehab through re-learning of lost function. Rehab-mediated improvements may be associated with brain functional changes in sensorimotor regions that can be measured with neuroimaging methods.

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History

    1. Started

      Jun 2012

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