Implementation of FEES in Spinal Muscle Atrophy

NCT04773470 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-12-10

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04773470 on ClinicalTrials.gov