Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552185
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Shereen M Fathi,MD, Kasr El Aini Hospital

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

Condition or disease
Multiple Sclerosis

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Depicting Neurogenic Dysphagia in Multiple Sclerosis Patients; Clinical and Endoscopic Studies
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. screen the prevalence of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires [ Time Frame: January 2018 - June 2018 ]
    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

  2. screen the prevalence of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires [ Time Frame: January 2018 - June 2018 ]
    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

  3. Assessment of neurogenic dysphagia in Egyptian MS patients attending Kasr Alainy hospital during specified peroid of time using validated dysphagia Questionnaires [ Time Frame: January 2018 - June 2018 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552185


Locations
Layout table for location information
Egypt
Kasralainy hospital
Cairo, Egypt, 11562
Sponsors and Collaborators
Kasr El Aini Hospital

Additional Information:

Layout table for additonal information
Responsible Party: Shereen M Fathi,MD, professor, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03552185     History of Changes
Other Study ID Numbers: SF
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shereen M Fathi,MD, Kasr El Aini Hospital:
Neurogenic Dysphagia
Multiple Sclerosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Deglutition Disorders
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases