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Clinical Trials/NCT03608527
NCT03608527
Completed
N/A

The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients

Fondazione Italiana Sclerosi Multipla0 sites30 target enrollmentSeptember 9, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Fondazione Italiana Sclerosi Multipla
Enrollment
30
Primary Endpoint
Change in the time to perform the Nine Hole Peg Test (NHPT)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined.

Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks.

Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.

Registry
clinicaltrials.gov
Start Date
September 9, 2013
End Date
March 4, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fondazione Italiana Sclerosi Multipla
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Multiple sclerosis diagnosis according to McDonald criteria
  • right handedness as assessed by the Edinburgh Handedness Inventory
  • absence of relapses in the last three months
  • mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)

Exclusion Criteria

  • steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
  • psychiatric disorders
  • severe cognitive impairment
  • magnetic resonance imaging contraindications

Outcomes

Primary Outcomes

Change in the time to perform the Nine Hole Peg Test (NHPT)

Time Frame: Baseline and 8 weeks

The NHPT is a brief, standardized, quantitative test of upper extremity function, requiring participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.

Secondary Outcomes

  • Grip and pinch strength(Baseline and 8 weeks)
  • Brain activity (blood-oxygenation-level dependent signal)(Baseline and 8 weeks)
  • Score obtained at the Action Research Arm Test (ARAT)(Baseline and 8 weeks)

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