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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00597844
First received: January 9, 2008
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Intrathoracic Malignancies
Unilateral Vocal Cord Paralysis
Other: voice evaluation and fMRI
Other: undergo voice evaluation and fMRI prior

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: July 2005
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
voice evaluation and fMRI prior to surgical rehabilitation of UVCP
Other: voice evaluation and fMRI
will undergo voice evaluation and fMRI prior to surgical rehabilitation of UVCP and in approximately one month and six months following treatment.
2
Healthy volunteers-voice evaluation and fMRI
Other: undergo voice evaluation and fMRI prior
in approximately one month and six months

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597844

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Kyung Peck, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00597844     History of Changes
Other Study ID Numbers: 05-036
Study First Received: January 9, 2008
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
type I thyroplasty
unilateral vocal fold augmentation

Additional relevant MeSH terms:
Paralysis
Vocal Cord Paralysis
Cranial Nerve Diseases
Laryngeal Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Signs and Symptoms
Vagus Nerve Diseases

ClinicalTrials.gov processed this record on November 25, 2014