Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03085316 |
Other study ID # |
141242 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 26, 2015 |
Est. completion date |
December 2025 |
Study information
Verified date |
December 2023 |
Source |
Vanderbilt University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Standard treatment options for patients who are diagnosed with BVFP include tracheostomy,
cordotomy, arytenoidectomy, and suture tie-back. These standard treatment options may result
in permanent damage to the vocal fold, therefore affecting the patient's ability to speak and
compromising airway protection during swallowing. Additionally, these routine procedures
cannot provide sufficient airway to permit significant aerobic activity. The goal in
conducting this early feasibility study is to investigate the use of this device as a
laryngeal pacemaker to treat BVFP.
Description:
The recurrent laryngeal nerve (RLN) carries motor fibers that innervate both the abductor
(PCA, opener) muscle and adductor (closer) muscles of the vocal folds. Damage to the nerve
compromises both of these functions and arrests the vocal folds in a near-closed position. In
case of BVFP, voice tends to be functional but airway embarrassment is often severe enough to
warrant tracheostomy to relieve inspiratory stridor and dyspnea.
If spontaneous recovery from nerve injury does not occur within one year, it is likely the
patient will be chronically paralyzed. In such instances, long-term tracheostomy could be
considered. Unfortunately, permanent tracheostomy is known to have the complications of
tracheal stenosis, chronic infection, and psycho-social impairment. For this reason,
laryngeal surgery is offered to enlarge the airway and restore breathing through the mouth.
These procedures, such as arytenoidectomy and cordotomy, where a portion of the larynx is
surgically resected to enlarge the airway, also have inherent complications.
Although they represent the standard of care, they adversely affect voice and may compromise
airway protection during swallowing. Further, they cannot provide sufficient airway to permit
significant aerobic activity. The limitations associated with these current therapies have
prompted investigation into a more physiologic, dynamic approach to rehabilitation:
reanimation of the paralyzed PCA muscle by functional electrical stimulation (FES).
Stimulation would be applied to the PCA muscle during the inspiratory phase of respiration to
open the vocal folds. During noninspiratory phases, stimulation would cease and the vocal
folds would passively relax to the midline to allow for normal voice production and airway
protection in swallowing. Based on the research the investigators have conducted, the
investigators expect patients would benefit from bilateral pacing through implantation of the
neurostimulator by restoring normal ventilation, without negatively affecting the patient's
voice or swallowing ability.
The investigators are collecting data in this study to show that this procedure is an
effective means of a surgical approach for implantation of device with insertion and
anchoring of the electrode leads. Incidence of complications both intraoperatively and
postoperatively will also be collected and assessed. Any complications will be addressed
according to current standard practice under the supervision of the operating surgeon. The
device should produce an airway that will allow patients to breathe without a tracheostomy
tube in place. Patients will be monitored for adverse events and managed accordingly.