Bilateral Vocal Fold Paralysis (BVFP) Clinical Trial
Official title:
Electrical Stimulation of Laryngeal Muscles to Restore Glottal Opening in Patients With Bilateral Vocal Fold Paralysis
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04028674 -
Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx
|
N/A |