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

Claudio Gobbi

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT02082002

EOC.NSI.13.02

Details and patient eligibility

About

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.

Full description

Objectives: 1- to provide a detailed characterization of fatigue in a cohort of selected MS patients, including a definition of the boundaries and the overlaps between fatigue, somnolence, mood disorders and attention dysfunction; 2- to see how the prevalence and the overlaps between fatigue, somnolence, depression and attention dysfunction are influenced by the method of assessment. 3-To better characterize the sleep structure in MS patients with fatigue under both the macro- and microstructural point of view.

Enrollment: 93 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

93 participants in 2 patient groups

MS-Group

Description:

MS-Group

Healthy control

Description:

Healthy control