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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00597844
• Date of registration: 09/01/2008
• Primary sponsor: Memorial Sloan-Kettering Cancer Center
• Public title: Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging
• Scientific title: Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging
• Date of first enrolment: July 2005
• Target sample size: 48
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00597844
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Kyung Peck, PhD
• Affiliation: Memorial Sloan-Kettering Cancer Center

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Intrathoracic Malignancies

Unilateral Vocal Cord Paralysis

Intervention(s)

Other: undergo voice evaluation and fMRI prior

Other: voice evaluation and fMRI

Primary Outcome(s)

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. [Time Frame: conclusion of study]

Secondary Outcome(s)

is to develop a better understanding of central sensory motor reorganization in a response to both a peripheral injury to the speech and swallowing mechanism and surgical repair of the speech and swallowing mechanism [Time Frame: conclusion of study]

Secondary ID(s)

05-036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors