Back to resultsImproving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging
Primary Purpose
Intrathoracic Malignancies, Unilateral Vocal Cord Paralysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
voice evaluation and fMRI
undergo voice evaluation and fMRI prior
Sponsored by
About this trial
This is an interventional diagnostic trial for Intrathoracic Malignancies focused on measuring type I thyroplasty, unilateral vocal fold augmentation
Eligibility 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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
voice evaluation and fMRI prior to surgical rehabilitation of UVCP
Healthy volunteers-voice evaluation and fMRI
Outcomes
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.
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
Full Information
NCT ID
NCT00597844
First Posted
January 9, 2008
Last Updated
September 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00597844
Brief Title
Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging
Official Title
Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrathoracic Malignancies, Unilateral Vocal Cord Paralysis
Keywords
type I thyroplasty, unilateral vocal fold augmentation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
voice evaluation and fMRI prior to surgical rehabilitation of UVCP
Arm Title
2
Arm Type
Other
Arm Description
Healthy volunteers-voice evaluation and fMRI
Intervention Type
Other
Intervention Name(s)
voice evaluation and fMRI
Intervention Description
will undergo voice evaluation and fMRI prior to surgical rehabilitation of UVCP and in approximately one month and six months following treatment.
Intervention Type
Other
Intervention Name(s)
undergo voice evaluation and fMRI prior
Intervention Description
in approximately one month and six months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Peck, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging
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