Status:
ACTIVE_NOT_RECRUITING
Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Bilateral Vocal Fold Paralysis (BVFP)
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The primary purpose of this project is to evaluate the safety of new treatment termed bilateral laryngeal pacing to improve treatment outcomes in patients with bilateral vocal fold paralysis (BVFP) (A...
Detailed Description
Despite recent advances in medicine, rehabilitation of the paralyzed larynx remains a complex clinical problem. Based on national health statistics, it is anticipated approximately 7,000 patients will...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form.
- Willingness to comply with all study procedures and availability for the duration of the study.
- Male or female adult patients, 22 years of age or older.
- Diagnosis of one of the following at least ten months prior to study enrollment:
- Complete bilateral vocal fold paralysis, with suspected etiological event occurring at least ten months prior to study enrollment. Diagnosis will be documented via medical records and confirmed during the onsite screening visit by a Vanderbilt board certified laryngologist via endoscopy, electromyography and direct laryngoscopy.
- Incomplete bilateral vocal fold paralysis (severe paresis) which significantly impedes respiration may also be considered for participation under the same conditions and per physician recommendation. Patients must present with an NGA less than 20, representing severe laryngeal obstruction. Diagnosis will be documented via medical records and confirmed during the onsite screening visit by a Vanderbilt board certified laryngologist via endoscopy, electromyography, and direct laryngoscopy.
- Patients receiving repeated botulinum toxin (botox) injections into the thyroarytenoid muscle to treat BVFP may be eligible for participation per physician recommendation.
- Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles (i.e. mean NGA ≥0.05 per vocal fold tested).
- Patients who have previously undergone a recurrent laryngeal nerve reinnervation procedure may be eligible for participation per physician recommendation. Patients must have undergone the laryngeal nerve reinnervation surgery at least 10 months prior to enrollment in the laryngeal pacing study.
- Patients who have previously undergone a recurrent laryngeal nerve reinnervation procedure may be eligible for participation per physician recommendation. Patients must have undergone the laryngeal nerve reinnervation surgery at least 10 months prior to enrollment in the laryngeal pacing study.
- Patients with or without a tracheostomy
- Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles (i.e. mean NGA ≥0.05 per vocal fold tested).
Exclusion
- Any active illness that is associated with an auto-immune disorder (such as diabetes).
- History of cardiac dysrhythmias or implanted cardiac pacemaker.
- Cardiac irregularities identified in screening electrocardiogram.
- Any electronic implanted medical device that, in the investigator's opinion, could interact with the laryngeal pacemaker.
- Active cardiac disease manifested by unstable angina, recent myocardial infarction, malignant arrhythmias, uncontrolled hypertension (diastolic greater than 110), or decompensated congestive heart failure.
- Patients with underlying comorbidities that, in the investigator's opinion, could potentially warrant a need for oxygen therapy, including but not limited to: Chronic obstructive pulmonary disease, asthma, emphysema, recurrent bronchitis, pneumonia or interstitial lung disease.
- Bilateral laryngeal immobility from stenosis or arthritis.
- Poor surgical risk patients as determined by the treating surgeon or Vanderbilt Preoperative Evaluation Center (VPEC).
- The abundance of interstitial fat may impede the surgical dissection. In the opinion of the principal investigator or treating physician(s), patients with factors that may complicate the surgical intervention will be excluded.
- Known allergy to barium dye or anesthetics.
- Known allergy to any of the device materials.
- History of aspiration pneumonia, secondary to bilateral vocal fold paralysis
- Persistent thin liquid dysphagia despite standard of care dysphagia management strategies (e.g. small sips, chin tuck, etc.)
- Presence of significant tracheal narrowing.
- Any anatomical abnormality that would jeopardize safe implantation, per the surgeon.
- Any medical condition, that in the opinion of the principal investigator or treating physician would jeopardize the outcome or welfare of the participant.
- Any previous medical treatment that in the opinion of the principal investigator or treating physician would confound the effects of laryngeal pacing.
- Females who are pregnant or plan a pregnancy within 2 years. A pregnancy test will be done as part of the routine pre-operative assessment for all females of child-bearing potential.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04028674
Start Date
January 14 2021
End Date
December 1 2025
Last Update
October 15 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232