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

Dysphagia Clinical Trial

— OPMD  

Official title:

Dysphagia in Oculopharyngeal Muscular Dystrophy. Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01167439
• Other study ID #: 0027-09-HYMC
• Status: Recruiting
• Phase: Phase 1
• First received: July 21, 2010
• Last updated: July 21, 2010
• Start date: July 2009

Study information

• Verified date: December 2009
• Source: Hillel Yaffe Medical Center
• Contact: Sergiu C. Blumen, MD
• Phone: 972-4-630-4262
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• heterozygote and homozygote OPMD patients

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Muscular Dystrophies
• Muscular Dystrophy, Oculopharyngeal

Intervention

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.

Locations

Country	Name	City	State
Israel	Israel National Center for OPMD and Dysphagia, HYMC	POB 169, Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty.	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.	at least 3 years	Yes