Mapping the Longitudinal, Multidimensional Impact of MS in Relation to Variables Indicative of Neurological Reserve

NCT06410326 | Completed

• 1 other identifier: Resilience
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

Some MS patients quickly accumulate neurological deficits, while others remain well for decades. Even though associations with age, sex, health behaviors, comorbidities and social determinants of health are widely acknowledged, the clinical heterogeneity in MS is poorly understood and variables with a robust prognostic value are lacking. Recent data suggest a key role for resilience in the central nervous system, potentially supporting the concept of neurological reserve in MS.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• EDSS

  The EDSS ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. In the lower part of its range, the EDSS score predominantly reflects the result of the examination by a neurologist, primarily a measure of impairment in eight functional systems (FS). In the middle part of its range, the EDSS score is primarily a measure of ambulation ability. At the higher end, upper limb and bulbar function as well as the ability to accomplish activities of daily living determine the score. The EDSS is considered to be an ordinal scale. The point estimates of the central tendency should be presented as median values and the measures of dispersion as interquartile ranges (Uitdehaag B, 2014). According to Havardova et al, MSJ 2017, the following disease severity groups can be distinguished: Mild EDSS 0-3 Moderate EDSS 4-6.5 Severe EDSS 7-9

  2 years

• Functional tests

  Functional tests of upper limbs (9-HPT) and lower limbs (25FWT) are measured in seconds. Higher scores indicate a worse function. A 20% change of the scores is considered to be a reasonable cutoff value for reliably detecting a clinically meaningful change.

  2 years

• Cognitive tests

  Cognitive screening tests include the PASAT (till 2015) and the SDMT (since 2015). The results are corresponding to the number of correct answers in a fixed time frame. Higher scores indicate a better function. The tests were usually performed on a yearly basis to limit learning effects.

  2 years

• The EQ-Visual Analog Score (EQ-VAS)

  The EQ-Visual Analog Score (EQ-VAS) records the patient's self-rated health on a vertical visual analogue scale, a kind of 'thermometer' where the endpoints are labelled 'The best health you can image' (endpoint 100 at the top) and 'The worst health you can image' (endpoint 0 at the bottom). The patient is asked to draw a line from the box marked 'Your health status today' to the appropriate point on the 'thermometer' scale. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. Five questions assessing five domains (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are included. A single index value can be generated.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis patients followed in the National MS center Belgium

You may qualify if:

• diagnosis of MS needs to be based on diagnostic criteria valid at the time of data entry and confirmed during follow up

You may not qualify if:

• Neuromyelitis Optica diagnosis, AQ4 positive or MOG positive

Sponsors & Collaborators

• National MS Center Melsbroek: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

Nationaal Multiple Sclerose Centrum Melsbroek

Melsbroek, Vlaams-Brabant, 1820, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr D'hooghe

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: May 13, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

BE (1)