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

September 4, 2013 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
OTHER: 2
Healthy volunteers-voice evaluation and fMRI
Other: undergo voice evaluation and fMRI prior
in approximately one month and six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (ESTIMATE)

January 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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