Implementation of FEES in Spinal Muscle Atrophy
NCT04773470 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2025-12-10
Summary
The major aim of this project is to assess comprehensively frequency and extent of dysphagia and bulbar dysfunction in SMA1, 2, and 3 patients by applying FEES and validated dysphagia scores. Further aims are to follow changes of dysphagia over time in newly diagnosed patients, and in subjects starting treatment with one of the new therapeutic SMA drugs. Special attention will be paid to subjects treated with Risdiplam. If applicable, the data will be compared between groups receiving different drugs.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
Flexible Endoscopic Evaluation of Swallowing
Endoscopical swallowing study
Sponsors & Collaborators
-
University of Giessen
lead OTHER
Principal Investigators
-
Samra Hamzic, MA · University Giessen
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2024-09-01
- Completion
- 2024-09-30
Countries
- Germany
Study Locations
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