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Dysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up (OPMD)

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ClinicalTrials.gov Identifier: NCT01167439
Recruitment Status : Unknown
Verified December 2009 by Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:
Hillel Yaffe Medical Center

Brief Summary:
The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in order to identify the best candidates and the proper timing to perform dysphagia alleviating procedures in both heterozygote and homozygote patients from the large pool of cases with this disease in Israel.

Condition or disease Intervention/treatment Phase
Dysphagia Procedure: Upper esophageal sphincter myotomy Phase 1

Detailed Description:
Clinical evaluation of patients suspected of having OPMD. Genetic confirmatory tests (diagnostic DNA test) at the genetic unit in Afula Hospital. Clinical follow-up with endoscopic fiber optic evaluation of swallowing. Pre-operative assessment. Crycopharyngeal myotomy intervention in selected patients. Nutrition follow-up.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dysphagia in Oculopharyngeal Muscular Dystrophy. Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up.
Study Start Date : July 2009
Estimated Primary Completion Date : July 2011


Arm Intervention/treatment
No Intervention: Mild dysphagia
Active Comparator: Severe dysphagia Procedure: Upper esophageal sphincter myotomy
Upper esophageal sphincter release operation to allow better swallowing. The intervention is done under GA and by extra-mucosal approach.



Primary Outcome Measures :
  1. Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty. [ Time Frame: at least 3 years ]
    Dysphagia, quality of life. Proper intervention timing in OPMD patients is very important and must be based on deep knowledge about the natural history of the feeding difficulty.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • heterozygote and homozygote OPMD patients

Exclusion Criteria:


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): NCT01167439


Contacts
Contact: Sergiu C. Blumen, MD 972-4-630-4262

Locations
Israel
Israel National Center for OPMD and Dysphagia, HYMC Recruiting
POB 169, Hadera, Israel, 38100
Contact: Sergiu C. Blumen, MD    972-52-2645938    navabl@hotmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Itzhak Bravermen, MD, Hillel Yaffe Medical Center, Hadera, Israel
ClinicalTrials.gov Identifier: NCT01167439     History of Changes
Other Study ID Numbers: 0027-09-HYMC
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: December 2009

Keywords provided by Hillel Yaffe Medical Center:
OPMD, dysphagia
Dysphagia severity
Nutritional state
Speech quality
Upper esophageal sphincter myotomy

Additional relevant MeSH terms:
Deglutition Disorders
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Muscular Dystrophies
Muscular Dystrophy, Oculopharyngeal