Laryngeal Pacing Device vs Repeated Botox Injections for BVFP
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04028674|
Recruitment Status : Not yet recruiting
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Vocal Fold Paralysis (BVFP)||Device: Laryngeal Pacing Device Drug: Botulinum toxin type A||Early Phase 1|
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 (PCA, opener) 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. 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. A previous 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. Ventilation outcomes compared to repeated Botox injections is unknown.
In the current project, investigators are collecting data to prove the overarching hypothesis that neuromuscular activation of the PCA muscles bilaterally reestablishes bilateral glottal opening and ventilation through the mouth without alteration of voice or swallowing, as occurs with Botox injections (Aim 1). 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 2). Incidence of complications intraoperatively/postoperatively and pre/post injection will also be collected and assessed. Any complications will be addressed according to current standard practice under the supervision of the treating physician. Patients will be monitored for adverse events and managed accordingly.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||All patients who meet eligibility will be randomly assigned to either arm. Treatments are administered and results compared.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Clinically-certified Speech Language Pathologists (SLPs) involved in perceptual ratings of voice quality (CAPE-V protocol) will be blinded to experimental condition and data collection time point. The procedures which will be blinded include PIF, CAPE-V, and NGA. Research team members performing the Exercise Tolerance and Flexible Endoscopic Examination of Swallowing (FEES) testing and are aware of the treatment condition. Due to the radiological nature of the Modified Barium Swallow (MBS) and Chest x-ray (CXR), technicians reading these exams cannot be blinded to condition. QOL assessments, including patient-reported breathing, voice, and swallowing function, Voice Handicap Index (VHI), Dysphagia Handicap Index (DHI) and Short Form 36 Health Survey (SF-36) surveys are self-reported measures and are therefore unblinded.|
|Official Title:||Comparison of Functional Electrical Stimulation to Repeated Botox Injections for the Treatment of the Bilaterally Paralyzed Human Larynx|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: Laryngeal Pacing Device
Patient who meets eligibility and randomized to this arm will be implanted with the St. Jude Medical Infinity™ Implantable Pulse Generator System (P140049), St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) Directional Lead and Extension (P140009), Swift-Lock™ Anchor (K092371), Butterfly anchor (P140009), manufactured by St. Jude Medical, Inc.
Device: Laryngeal Pacing Device
Device is an implantable neurostimulation system designed to deliver low-intensity electrical impulses to nerve structures.
Active Comparator: Repeated Botox Injections
Patients who meet eligibility and randomized to this arm will receive repeated Botulinum Toxin A injections.
Drug: Botulinum toxin type A
Repeated Botox injections
Other Name: Botox
- Improved ventilation due to laryngeal pacing device as assessed by increase in standard assessment testing (peak inspiratory flow or PIF). [ Time Frame: 15 months ]
- Better voice quality as assessed by decrease in standard assessment testing (Consensus Auditory Perceptual Evaluation of Voice or CAPE-V). [ Time Frame: 15 months ]
- Increased glottal area due to laryngeal pacing device as assessed by increase in normalized glottal area (NGA) results. [ Time Frame: 15 months ]
- Increase in exercise tolerance due to laryngeal pacing device as assessed by treadmill testing. [ Time Frame: 15 months ]
- Better quality of life (QOL) outcomes due to laryngeal pacing device, self assessed via patient reported outcome surveys. [ Time Frame: 15 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028674
|Contact: Kate Von Wahlde, MJfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||David L. Zealear, PhD||Vanderbilt University Medical Center|