Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging
The purpose of this investigation is to determine cortical mechanisms of adaptation to
surgical rehabilitation of patients with unilateral vocal cord paralysis (UVCP) undergoing
either type I thyroplasty or unilateral vocal fold augmentation for the management of
unilateral vocal cord paralysis. This study will use the non-invasive imaging technique,
Functional Magnetic Resonance Imaging (fMRI), to investigate cortical responses and
responses in the larynx of patients with UVCP who have been deemed to be candidates for
either type I thyroplasty or unilateral vocal fold augmentation for the purpose of
rehabilitating this UVCP. Patterns of brain activity from the fMRI studies will be compared
with the preoperative study with each patient serving as their own control for the purpose
of evaluating the alterations in sensory motor organization of the brain in response to
UVCP. In addition, responses in patients with UVCP will be compared to normal controls. This
will allow us to identify the impact on speech and swallowing and the subsequent
reorganization which we theorize will occur in response to the vocal cord medialization.
Patients will undergo standardized voice evaluation with improvement in voice serving as a
secondary endpoint. The results of the current investigation will provide needed information
on both central and peripheral mechanisms of adaptation.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
utilize fMRI technique to characterize adaptation to alterations in vocal cord morphology, speech & swallowing function in patients with UVCP undergoing procedure for rehab of speech and swallowing, either type I thyroplasty or vocal fold augment.
conclusion of study
No
Kyung Peck, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
05-036
NCT00597844
July 2005
July 2013
Name | Location |
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Memorial Sloan Kettering Cancer Center | New York, New York 10021 |