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Trial record 4 of 9 for:    Pacemakers OR pacemaker | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Laryngeal Pacing Device vs Repeated Botox Injections for BVFP

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ClinicalTrials.gov Identifier: NCT04028674
Recruitment Status : Not yet recruiting
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
David Zealear, Vanderbilt University Medical Center

Brief Summary:
The purpose of this project is to compare the safety and efficacy of a new treatment termed bilateral laryngeal pacing to a standard of care option, botulinum toxin A injections (Botox), for the treatment of bilateral vocal fold paralysis (BVFP). Participants will be randomized to receive either standard of care (SOC) treatment or implantation of laryngeal pacemaker. Longitudinal outcomes related to ventilation, voicing, and swallowing will be used to evaluate the efficacy of each treatment paradigm.

Condition or disease Intervention/treatment Phase
Bilateral Vocal Fold Paralysis (BVFP) Device: Laryngeal Pacing Device Drug: Botulinum toxin type A Early Phase 1

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Paralysis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Improved ventilation due to laryngeal pacing device as assessed by increase in standard assessment testing (peak inspiratory flow or PIF). [ Time Frame: 15 months ]
  2. Better voice quality as assessed by decrease in standard assessment testing (Consensus Auditory Perceptual Evaluation of Voice or CAPE-V). [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. Increased glottal area due to laryngeal pacing device as assessed by increase in normalized glottal area (NGA) results. [ Time Frame: 15 months ]
  2. Increase in exercise tolerance due to laryngeal pacing device as assessed by treadmill testing. [ Time Frame: 15 months ]
  3. Better quality of life (QOL) outcomes due to laryngeal pacing device, self assessed via patient reported outcome surveys. [ Time Frame: 15 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 bilateral vocal fold paralysis, at least ten months prior to study enrollment. This 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.
  • Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles (i.e. mean NGA ≥0.05 per vocal fold tested).

Exclusion Criteria:

  • History of cardiac dysrhythmias or implanted cardiac pacemaker
  • 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
  • Known allergy to Botulinum Toxin A (Botox)
  • Patients with pre-existing liquid dysphagia
  • 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 either repeated Botox injections or laryngeal pacing procedures
  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Kate Von Wahlde, MJ 615-322-0333 kate.vonwahlde@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: David L. Zealear, PhD Vanderbilt University Medical Center

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Responsible Party: David Zealear, Professor, Department of Otolaryngology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04028674     History of Changes
Other Study ID Numbers: pending IRB number
5U01DC016033 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents