NCT02082002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

5.1 years

First QC Date

March 6, 2014

Last Update Submit

March 20, 2019

Conditions

Multiple Sclerosis

Keywords

Multiple scerlosisFatigueSleepSomnolenceDepressionCognitive disorders

Outcome Measures

Primary Outcomes (1)

  • Fatigue Severity Scale

    a self-administered 9-items scale. The patient gives a score from 1 to 7 to each item. The resulting score is given as the mean value. Subjects with a score higher that 4 are considered fatigued. This scale assesses the impact of fatigue on multiple outcomes, with a physical focus. FSS has been validated for MS, it has an acceptable internal consistency, it is a reliable, completely safe and brief scale, which in addition has been shown to follow clinical changes in fatigue perception over time. Furthermore, FSS scores correlate with other commonly used fatigue scales, like the Modified Fatigue Impact Scale

    1 Day

Secondary Outcomes (11)

  • Modified Fatigue Impact Scale

    1 Day

  • Fatigue Scale for Motor and Cognitive functions

    1 Day

  • Visual analogue scale for fatigue

    1 Day

  • Maintenance of wakefulness test

    1 Day

  • Epworth Sleepiness Scale

    1 Day

  • +6 more secondary outcomes

Other Outcomes (26)

  • State-Trait Anxiety Inventory Form Y

    1 Day

  • SCID-I Disorders- Patient Edition

    1 Day

  • Selective Reminding Test

    1 Day

  • +23 more other outcomes

Study Arms (2)

MS-Group

MS-Group

Healthy control

Healthy control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multiple sclerosis

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale di Lugano - Civico

Lugano, Canton Ticino, 6903, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 17409388BACKGROUND

  • 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.

    PMID: 18632776BACKGROUND

  • 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.

    PMID: 15096400BACKGROUND

  • 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.

    PMID: 12883103BACKGROUND

  • Jongen PJ, Ter Horst AT, Brands AM. Cognitive impairment in multiple sclerosis. Minerva Med. 2012 Apr;103(2):73-96.

    PMID: 22513513BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple SclerosisFatigueSleepinessDepressionCognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Claudio Gobbi, MD

    Ospedale Regionale di Lugano - Civico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr med., Vice head physician

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 7, 2014

Study Start

November 1, 2013

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)