Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Fatigue, Nutritional Status, Disability.
Brief summary
Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of disability after injury accidents in young adults. Among the many symptoms, fatigue is very common with a significant impact on quality of life. Also, the disability caused by multiple sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often deficient in this population with consequences in physical performance such as endurance and muscle strength. We propose to study the link between fatigue and shortcomings encountered in a defined population of MS patients.
Interventions
PROCEDUREBlood sampling
A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.
OTHERGustatory sensitivity test using Taste strips
16 Taste Strips impregnated with 4 flavors (sweet, sour, salty, bitter, each flavor present at 4 different concentrations), are offered to the patient one after the other in a so-called pseudorandomized sequence. The task of the patient is to choose one of the following answers: sweet / sour / salty / bitter / no taste. Each correct answer is granted one point. In addition to the impregnated strips, two tasteless strips can be integrated in the examination at any point of time (no point)
OTHERQuestionnaires
Evaluation of the following parameters by validated questionnaires (name of the questionnaire in bracket): * Fatigue (EMIF-SEP) * Dysphagia (DYMUS) * Food intake (semi-structured questionnaire) * Depression (BDI-II) * Daily energy expenditure (NAP) * Visual analog scale to study quality of sleep
Sponsors
Lille Catholic University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18 and 65 years old * Expended disability status scale (EDSS) between 0 and 7 * Diagnosis of MS according to the revised criteria of McDonald * Clinically stable patients in the past 3 months * Coverage of the social insurance * Informed consent to participate
Exclusion criteria
* Cognitive disorders that can hinder answering questionnaires * Presence of uncontrolled metabolic disease(s) * Malabsorption * Patients with a gastrostomy * Active cancer under treatment * Anorexia * Pregnancy or breast feeding * Severe psychiatric disorder(s) * No informed consent to participate * No coverage by the social insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the score of fatigue EMIF-SEP and the dosage of nutrients in blood (vitamins, minerals, proteins) adjusted by the EDSS status | Baseline | The objective is to construct and validate a regression model between the scale of fatigue and biological variables |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of physical activity and daily energy expenditure | Baseline | — |
| Assessment of dysphagia according to the score of the Dymus Test | Baseline | — |
| Score of the taste sensibility test | Baseline | — |
| Presence or absence of clinical manifestations | Baseline | — |
| Score of the Beck depression inventory test | Baseline | This test is a 21-question multiple-choice self-report inventory for measuring the severity of depression |
| Score of the visual analog scale for the evaluation of sleep quality | Baseline | — |
| Score of the Nutrition and Eating Habits Questionnaire | Baseline | — |
| Presence or absence of sociodemographic variables | Baseline | — |
Countries
France
Outcome results
None listed