Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-12-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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MS-Group

No interventions assigned to this group

Healthy control

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes