Depicting Neurogenic Dysphagia in Multiple Sclerosis Patients; Clinical and Endoscopic Studies

NCT03552185 | Completed DMC

• 1 other identifier: SF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Keywords

Neurogenic Dysphagia; Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• screen the prevalence of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires

  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 using Ten-item questionnaire for assessment of dysphagia in multiple sclerosis (DYMUS). The higher the score the more or worse dysphagia. the score range from 0 - 10. Patient scored 3 or more on DYMUS questionnaire considered to have dysphagia

  January 2018 - June 2018

• screen the prevalence of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires

  To screen the prevalence of neurogenic dysphagia in Egyptian MS patients having dysphagia by questionnaires attending Neurology Outpatient Clinic \& Neurology Department at Kasr Alainy Hospital within a definite time interval using Dysphagia handicap index (DHI). The higher the score the more or worse dysphagia. the score range from 1 - 7. no cut off value

  January 2018 - June 2018

• Assessment of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires

  To assess severity/degree of neurogenic dysphagia in Egyptian MS patients attending Neurology Outpatient Clinic \& Neurology Department at Kasr Alainy Hospital within a definite time interval using Flexible Endoscopic Evaluation of Swallowing (FEES) for MS patients with dysphagia. it measures degree of dysphagia endoscopically, and the higher the score the more or worse dysphagia. no cut off value. the score range from 1 - 15.

  January 2018 - June 2018

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Patients diagnosed with Multiple Sclerosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy hospital

Cairo, 11562, Egypt

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: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 11, 2018
• Study Start: January 1, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

EG (1)