Depicting Neurogenic Dysphagia in Multiple Sclerosis Patients; Clinical and Endoscopic Studies
Condition: Multiple Sclerosis
MeSH terms: Deglutition Disorders; Multiple Sclerosis; Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to evaluate neurogenic dysphagia in Multiple Sclerosis patients
      using dysphagia questionnaires and endoscopic study; and to correlate that to MS types,
      severity, duration, and imaging modalities
    

Detailed description: 
      Objectives:

      The purpose of this study is to evaluate neurogenic dysphagia in Multiple Sclerosis patients
      using dysphagia questionnaires and endoscopic study; and to correlate that to MS types,
      severity, duration, and imaging modalities

      Study Design:

      Observational, descriptive study

      Population of study and disease condition:

      Egyptian patients with Clinically Definite Multiple sclerosis according to the MAGNIMS
      consensus Guidelines and MCdonald's criteria 2017

      Selected patients will be all Multiple Sclerosis patients attending Neurology Outpatient
      Clinic & Neurology Department at Kasr Alainy Hospital within a definite time interval
      (January 2018- June 2018) with an estimate of 100 patients.

      A written consent, approved by the ethical committee of Neurology Department, faculty of
      medicine, Cairo University will be obtained for each participant.

      Methodology in details:

      Patients in this study will be submitted to the following:

        1. Through history taking and meticulous neurological examination.

        2. Clinical & assessment scales:

             1. Expanded Disability status scale (EDSS)

             2. 10-item Dysphagia in Multiple Sclerosis questionnaire (DYMUS): Ten-item
                questionnaire for assessment of dysphagia in multiple sclerosis. The questionnaire
                can be divided into two subscales; for the assessment of dysphagia for solids (7
                items, in bold), and for the assessment of dysphagia for liquids (3 items, in
                italics). Instructions for the patient: This questionnaire is about your ability to
                swallow.

             3. Dysphagia handicap index (DHI): new, easy-to-complete, statistically robust,
                patient-reported outcomes measure for assessing the handicapping effect of
                dysphagia. These statements were 60 in number and were sorted into three subscales
                based on their content. The emotional subscale consisted of 16 statements
                representing a person's affective response to their dysphagia. There were 27
                statements representing a person's self-perception of physical discomfort due to
                dysphagia. There were 27 statements representing a person's self-perception of
                physical discomfort due to dysphagia. In order to evaluate an overall picture of
                the patient's perception of their dysphagia, all subscales were combined to provide
                an overall total DHI score. At the completion of the test, subjects were asked to
                self-rate the severity of their dysphagia on a 7-point equal appearing interval
                scale.

        3. Flexible Endoscopic Evaluation of Swallowing (FEES): will be performed to MS patients
           with dysphagia as detected by dysphagia questionnaires.

        4. Neuro-imaging: Magnetic Resonance imaging of the brain and spinal cord with contrast
           were performed for patients on a 1.5 Tesla Phillips Intera® Scanner at the Magnetic
           Resonance unit, Department of Radio-diagnosis, Cairo University. The following protocols
           were used:

             -  T1-weighted images (axial & sagittal)

             -  T2-weighted images (axial & coronal)

             -  Fluid attenuated inversion recovery (FLAIR) sequence

      Correlation of endoscopy result with type of MS (whether RRMS or progressive form), severity
      of disease (as assessed by EDSS), duration of disease (number of years since first symptom),
      and lesion load (assessed by MRI)

      Possible Risk:

      Uncommon complications of FEES as epistaxis and vasovagal attack (very rare).

      Primary outcomes:

      To screen the prevalence of neurogenic dysphagia in Egyptian MS patients attending Neurology
      Outpatient Clinic & Neurology Department at Kasr Alainy Hospital within a definite time
      interval( January 2018 - June 2018)

      Secondary outcome parameters (other outcomes to be assessed) To depict neurogenic dysphagia
      in MS and assessment of its efficiency as a biomarker for disease progression.

      Statistical analysis:

      Results will be evaluated statistically by Statistical Package for the Social Sciences "SPSS"
      version 16.

      Data will be summarized using mean and standard deviation for quantitative variables and
      percent for qualitative variables.

      Comparison between groups will be done using chi square test for quantitative variables &
      ANOVA (analysis of variance).

      Multiple comparisons will be done using post Hoc test for normally distributed quantitative
      variables and parametrical. Mann-Whitney test for not normally distributed quantitative
      variables.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Egyptian patients with Clinically Definite Multiple sclerosis according McDonald's criteria
        2017

        Selected patients will be all Multiple Sclerosis patients attending Neurology Outpatient
        Clinic & Neurology Department at Kasr Alainy Hospital within a definite time interval
        (January 2018- June 2018) with an estimate of 100 patients
      
Keywords: Neurogenic Dysphagia; Multiple Sclerosis