Clinical trial NCT02082002: Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino
Official title: Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple scerlosis
Fatigue
Sleep
Somnolence
Depression
Cognitive disorders
Lead sponsor: Ospedale Civico, Lugano
Sponsor class: OTHER_GOV
Collaborators: name: Swiss Multiple Sclerosis Society
First posted: 2014-03-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple sclerosis

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 1 Day
Secondary outcomes:
measure: Modified Fatigue Impact Scale
timeFrame: 1 Day
measure: Fatigue Scale for Motor and Cognitive functions
timeFrame: 1 Day
measure: Visual analogue scale for fatigue
timeFrame: 1 Day
measure: Maintenance of wakefulness test
timeFrame: 1 Day
measure: Epworth Sleepiness Scale
timeFrame: 1 Day
measure: Visual analogue scale for somnolence
timeFrame: 1 Day
measure: Beck depression inventory II
timeFrame: 1 Day
measure: Mongomery Asberg Depression Rating Scale
timeFrame: 1 Day
measure: Symbol Digit Modalities Test
timeFrame: 1 Day
measure: Paced Auditory Serial Addition Test
timeFrame: 1 Day
measure: Stroop Test
timeFrame: 1 Day
Other outcomes:
measure: State-Trait Anxiety Inventory Form Y
timeFrame: 1 Day
measure: SCID-I Disorders- Patient Edition
timeFrame: 1 Day
measure: Selective Reminding Test
timeFrame: 1 Day
measure: 10/36 Spatial Recall Test
timeFrame: 1 Day
measure: Word List Generation
timeFrame: 1 Day
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 Day
measure: Psychomotor Vigilance Task
timeFrame: 1 Day
measure: Multiple Sclerosis quality of life (MSQol-54)
timeFrame: 1 Day
measure: Sleep parameter time in bed
timeFrame: 1 Day
measure: Sleep parameter Total Sleep Time (min)
timeFrame: 1 Day
measure: Sleep parameter Sleep efficiency (% TST/Time spent in bed)
timeFrame: 1 Day
measure: Sleep parameter Wake after sleep onset
timeFrame: 1 Day
measure: Sleep parameter Number of awakenings
timeFrame: 1 Day
measure: Sleep parameter Stage N1 (% of TST)
timeFrame: 1 Day
measure: Sleep parameter Stage N2 (% of TST)
timeFrame: 1 Day
measure: Sleep parameter Stage N3 (% of TST)
timeFrame: 1 Day
measure: Sleep parameter Stage REM (% of TST)
timeFrame: 1 Day
measure: Sleep parameter Total arousal index
timeFrame: 1 Day
measure: Sleep parameter Limb movements index (nr/hour of sleep)
timeFrame: 1 Day
measure: Sleep parameter Periodic limb movement index (nr/hr of sleep)
timeFrame: 1 Day
measure: Sleep parameter Apnea/hypopnea Index (nr/hr of sleep)
timeFrame: 1 Day
measure: Sleep parameter Oxygen desaturation index (nr of desaturations ≥ 4% /hr of sleep)
timeFrame: 1 Day
measure: Sleep parameter Cyclic alternating pattern rate
timeFrame: 1 Day
measure: Sleep parameter Phases A1 rate (nr/hr of non-REM)
timeFrame: 1 Day
measure: Sleep parameter Phases A2 rate (nr/hr of non-REM)
timeFrame: 1 Day
measure: Sleep parameter Phases A3 (nr/hr of non-REM)
timeFrame: 1 Day
Locations:
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano - Civico
state: Ticino
Study officials:
affiliation: Ospedale Regionale di Lugano - Civico
name: Claudio Gobbi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1177/1545968306298934. Epub 2007 Apr 4.
citation: Bamer AM, Johnson KL, Amtmann D, Kraft GH. Prevalence of sleep problems in individuals with multiple sclerosis. Mult Scler. 2008 Sep;14(8):1127-30. doi: 10.1177/1352458508092807. Epub 2008 Jul 16.
citation: Attarian HP, Brown KM, Duntley SP, Carter JD, Cross AH. The relationship of sleep disturbances and fatigue in multiple sclerosis. Arch Neurol. 2004 Apr;61(4):525-8. doi: 10.1001/archneur.61.4.525.
citation: Mohr DC, Hart SL, Goldberg A. Effects of treatment for depression on fatigue in multiple sclerosis. Psychosom Med. 2003 Jul-Aug;65(4):542-7. doi: 10.1097/01.psy.0000074757.11682.96.
citation: Jongen PJ, Ter Horst AT, Brands AM. Cognitive impairment in multiple sclerosis. Minerva Med. 2012 Apr;103(2):73-96.