Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04028674 |
Other study ID # |
200932 |
Secondary ID |
5U01DC016033 |
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 14, 2021 |
Est. completion date |
December 2025 |
Study information
Verified date |
April 2024 |
Source |
Vanderbilt University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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) (Aim 1). Outcome measures related to voice and ventilation will also
provide initial insights into the efficacy of bilateral (Aim 2) and unilateral (Aim 3)
stimulation of the implanted device to improve treatment outcomes in patients with BVFP.
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 be diagnosed with BVFP in the United States each year. BVFP is a serious and
often life-threatening clinical condition. The recurrent laryngeal nerve (RLN) carries motor
fibers that innervate both the abductor muscle (posterior cricoarytenoid muscle) and adductor
muscles of the vocal folds. Damage to the nerve compromises both of these functions and
arrests the vocal folds in a near-closed position. With BVFP, voice tends to be functional,
but airway compromise is often severe enough to warrant tracheotomy to relieve inspiratory
stridor and dyspnea. If spontaneous recovery does not occur within one year, it is likely
that the patient's vocal folds will be chronically paralyzed. In such instances, long-term
tracheostomy can be considered. Unfortunately, permanent tracheostomy is associated with
complications such as tracheal stenosis, chronic infection, and psycho-social impairment. For
this reason, laryngeal surgery is usually recommended to enlarge the airway and restore
breathing through the mouth. Procedures such as arytenoidectomy, cordotomy, or repeated Botox
injections, regarded as the standard of care for enlarging the airway, also have inherent
complications. Specifically, they impair voice and compromise airway protection during
swallowing. The limitations associated with these current treatments have prompted
investigation into a more physiologic, dynamic approach to rehabilitation: reanimation of the
paralyzed PCA muscle by functional electrical stimulation (FES). Ideally, stimulation should
be applied during the inspiratory phase of respiration to abduct the vocal folds. This has
been termed "laryngeal pacing". During non-inspiratory phases, stimulation would cease, and
the vocal folds would passively relax to the midline to allow for normal voice production and
airway protection. Previously, our clinical trial of unilateral pacing demonstrated a
significantly greater return of ventilation without any compromise of voice or swallowing.
However, the level of ventilation was only marginally better than that associated with
cordotomy.
In the current project, we will investigate the safety of a novel intervention (laryngeal
pacing) for BVFP (Aim 1). The overarching hypothesis is that neuromuscular activation of the
PCA muscles bilaterally reestablishes bilateral glottal opening and ventilation through the
mouth without alteration of voice or swallowing, compared to a sham-operated control (Aim 2).
The ventilation from bilateral pacing should be significantly greater than from unilateral
pacing and allow the patient to engage in a normal pre-paralysis activity level (Aim 3).