Clinical trial NCT03552185: Depicting Neurogenic Dysphagia in Multiple Sclerosis Patients; Clinical and Endoscopic Studies
Official title: Depicting Neurogenic Dysphagia in Multiple Sclerosis Patients; Clinical and Endoscopic Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Neurogenic Dysphagia
Multiple Sclerosis
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
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

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Multiple Sclerosis

Exclusion Criteria:

* Local causes of Dysphagia excluded by proper history taking, proper clinical examination (e.g.; esophageal tumor, GERD, Achalasia, Radiation therapy)
* Anatomical changes in the oral cavity, pharynx and larynx that might interfere with swallowing (i.e.: , history of recent trauma to the nasal cavity or surrounding tissue )
* Patients with tracheostomy or a history of having been submitted to it.
* Patients with contraindications of Flexible Endoscopic Evaluation of Swallowing as severe dyskinesia.
* Severe bleeding disorders and/or recent severe epistaxis, and bilateral obstruction of the nasal passages.
* History of major systemic disease e.g.; renal, hepatic, thyroid diseases, and collagen vascular disorders.
* Non cooperative patients

Primary outcomes:
measure: screen the prevalence of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires
timeFrame: January 2018 - June 2018
measure: screen the prevalence of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires
timeFrame: January 2018 - June 2018
measure: Assessment of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires
timeFrame: January 2018 - June 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy hospital
Study officials:
References: