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

NCT00597844 | Completed

• 1 other identifier: 05-036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how the brain re-learns to control the larynx in speaking and swallowing when undergoing surgical rehabilitation in the form of either thyroplasty or vocal fold augmentation for unilateral vocal cord paralysis. What is needed is information on how the brain re-learns to control speaking and swallowing so that we can eventually learn how to help patients re-learn faster after their procedure. Functional Magnetic Resonance Imaging (or fMRI) will allow us to image your brain as you speak and swallow. We will produce "brain maps" for speaking, swallowing and hand movements.

Conditions

Intrathoracic Malignancies; Unilateral Vocal Cord Paralysis

Keywords

type I thyroplasty; unilateral vocal fold augmentation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

  conclusion of study

Study Arms (2)

1

EXPERIMENTAL

voice evaluation and fMRI prior to surgical rehabilitation of UVCP

Other: voice evaluation and fMRI

2

OTHER

Healthy volunteers-voice evaluation and fMRI

Other: undergo voice evaluation and fMRI prior

Interventions

voice evaluation and fMRI OTHER

will undergo voice evaluation and fMRI prior to surgical rehabilitation of UVCP and in approximately one month and six months following treatment.

1

undergo voice evaluation and fMRI prior OTHER

in approximately one month and six months

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with UVCP undergoing type I thyroplasty or vocal fold augmentation for rehabilitation of speech and swallowing.
• From age 18-85

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyung Peck, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: July 1, 2005
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)