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

Unilateral Vocal Cord Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597844
• Other study ID #: 05-036
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: September 4, 2013
• Start date: July 2005
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Intrathoracic Malignancies
• Paralysis
• Unilateral Vocal Cord Paralysis
• Vocal Cord Paralysis

Intervention

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.
• undergo voice evaluation and fMRI prior
in approximately one month and six months

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes

External Links

•   Memorial Sloan-Kettering Cancer Center