To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL). The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.

Detailed Description
-----------------
One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability. The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity. The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS. The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.

Official Title
-----------------
Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina

Conditions
-----------------
Multiple Sclerosis, Relapsing Remitting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged from 21 60 years of age Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005 Subjects with a diagnosis of RRMS for more than one year The subject who have signed the Informed Consent Exclusion Criteria: Subjects with other causes of spasticity Subjects with other clinical forms of MS (different from relapsing-remitting)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the prevalence of spasticity in subjects with RRMS | Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36 | Initial visit (Day 0) to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the impact of spasticity on the quality of life of subjects with RRMS |  | Initial visit (Day 0) to 24 months | 
| Evaluation of the changes in spasticity after 24 months |  | Initial visit (Day 0) to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Relapsing Remitting, Quality of life