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Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging


N/A
18 Years
85 Years
Open (Enrolling)
Both
Intrathoracic Malignancies, Unilateral Vocal Cord Paralysis

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Trial Information

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.


Inclusion Criteria:



- Patients with UVCP undergoing type I thyroplasty or vocal fold augmentation for
rehabilitation of speech and swallowing.

- Inclusion criteria for the healthy subjects:

- From age 18-85

Exclusion Criteria:

- for the UVCP patients includes the following:

- History of significant psychiatric condition (e.g. schizophrenia,
obsessive-compulsive disorder, significant dementia),

- History of the following neurological conditions: CVA, seizure disorders,
demyelinating conditions, systemic neuromuscular disorders, cerebral palsy,
Alzheimer's disease.

- History of previous moderate to severe traumatic brain injury.

- History of significant cardiovascular, gastrointestinal or renal disease (e.g.
myocardial infarction within the previous 12 months, significant vaso-occlusive
disease, severe or advanced asthma, or renal compromise)

- History of achalasia

- History of dysphagia, odynophagia, or aphasia unrelated to present illness.

- History of significant claustrophobic reactions.

- Standard contraindications to MR examinations (e.g. implanted stimulators,
pregnancy).

Exclusion criteria for the healthy subjects includes the following:

- All of the conditions listed for the UVCP patients.

- Significant surgery or previous radiation therapy to the head and neck.

- History of other neoplasms involving the brain, head and neck, or gastrointestinal
system.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Kyung Peck, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

05-036

NCT ID:

NCT00597844

Start Date:

July 2005

Completion Date:

July 2013

Related Keywords:

  • Intrathoracic Malignancies
  • Unilateral Vocal Cord Paralysis
  • type I thyroplasty
  • unilateral vocal fold augmentation
  • Neoplasms
  • Vocal Cord Paralysis
  • Paralysis

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021