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Multiple Sclerosis | Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino

Multiple Sclerosis research study

What is the primary objective of this study?

Fatigue is a common symptom in patients with multiple sclerosis, however, its nature is not completely understood. Fatigue overlaps often with other symptoms such as somnolence, depression and cognitive disorders, from which it is not always readily distinguished. The evaluation of fatigue and the three most frequently associated symptoms using a multidimensional approach might allow to understand, which methodology is the best indicated to estimate the prevalence of fatigue with greatest accuracy, leading to a better differentiation of the symptoms in the diagnostic setting.

Who is eligible to participate?

Inclusion Criteria: - Definite diagnosis of MS (14,15) or CIS (16);according to the most recent standard criteria - Expanded Disability Status Scale (EDSS) score < 7.0 (17); - Last magnetic resonance imaging (MRI) within the previous 12 months; - Male or female; - >18 years old; - Willing to perform the study procedures; - Signed Informed consent. Exclusion Criteria: - Mini Mental Status Examination (MMSE) score < 24; - Relapse within the last 3 months; - Radiologically isolated syndrome (RIS); - History of drug and/or alcohol abuse; - Any serious general medical condition like decompensated cardiopulmonary disease, cancer or decompensated renal failure, as well as any neurological condition (other than MS) that can interfere with the correct execution of the study design.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Multiple Sclerosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MS-GroupMS-Group

Healthy controlHealthy control

Study Status

Recruiting

Start Date: November 2013

Completed Date: December 2018

Phase:

Type: Observational

Design:

Primary Outcome: Fatigue Severity Scale

Secondary Outcome: Modified Fatigue Impact Scale

Study sponsors, principal investigator, and references

Principal Investigator: Claudio Gobbi, MD

Lead Sponsor: Claudio Gobbi

Collaborator: Swiss Multiple Sclerosis Registry

More information:https://clinicaltrials.gov/show/NCT02082002

Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. Epub 2007 Apr 4. Review.

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