Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Voluntary-based upper limb motor rehabilitation; Behavioral: Passive upper limb mobilization

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active motor treatment (AMT) group; 15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week).	Behavioral: Voluntary-based upper limb motor rehabilitation; Exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, mainly including task-oriented movements with the goal to improve activities of daily living. Both proximal and distal muscles are involved, in actions such as grasping wooden cubes of different sizes, pinching, reaching targets displayed in front of the patient, and doing patchwork or paper mandala.
Active Comparator: Passive motor treatment (PMT) group; 15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week).	Behavioral: Passive upper limb mobilization; Passive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the time to perform the Nine Hole Peg Test (NHPT)	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.	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score obtained at the Action Research Arm Test (ARAT)	The Action Research Arm Test is an observational measure used to assess upper extremity performance (coordination, dexterity and functioning). The scale ranges from 0 to 57, with higher scores indicating better outcomes. Items are categorized into four subscales: grasp (score 0-18) , grip (0-12), pinch (0-18) and gross movement (0-9) which are arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task.	Baseline and 8 weeks
Grip and pinch strength	Force applied by the hand and the fingers measured by means of specific dynamometers	Baseline and 8 weeks
Brain activity (blood-oxygenation-level dependent signal)	Task-related brain activations assessed by means of functional magnetic resonance imaging during a finger-to-thumb opposition sequence	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Fondazione Italiana Sclerosi Multipla
• Collaborators: Universita degli Studi di Genova
• Investigators: Principal Investigator: Marco Bove, Prof, University of Genoa

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2013
• Primary Completion (Actual): December 22, 2014
• Study Completion (Actual): March 4, 2015

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: functional magnetic resonance imaging; Upper limb motor rehabilitation; Voluntary movements
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: FISM 2011R8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No