Laryngeal Pacing Study (BVFP IDE)

February 25, 2025 updated by: David Zealear, PhD, Vanderbilt University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female adult patients, 22 years of age or older
  • Diagnosis of bilateral vocal fold paralysis, at least one year prior to study enrollment
  • Must have tracheostomy in place minimum of 6 weeks prior to implantation of St.Jude Medical Infinity™ IPG device
  • Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles
  • Demonstrated peak inspiratory flow with respiratory testing through the mouth of at least 0.4 L/sec

Exclusion Criteria:

  • Any active illness that is associated with an immune disorder (such as diabetes)
  • 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)
  • Patients with acute or chronic infections
  • 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
  • Patients who in the opinion of the investigator, based on needle stimulation testing, have insufficient PCA muscle mass to implant leads
  • Patients with pre-existing liquid dysphagia
  • Presence of significant tracheal narrowing
  • Any anatomical abnormality that would jeopardize safe implantation, per the treating 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 history of keloid formation or hypertrophic scarring
  • Females who are pregnant or plan a pregnancy within 1 year. A pregnancy test will be done as part of the routine pre-operative assessment for all females of childbearing potential.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational Device
Patient who meets eligibility to 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: Investigational device
Device is an implantable neurostimulation system designed to deliver low-intensity electrical impulses to nerve structures.
Other Names:
  • St. Jude Medical Infinity™ Implantable Pulse Generator System (P140049), Deep Brain Stimulation (DBS) Directional Lead and Extension (P140009), Swift-Lock™ Anchor (K092371), Butterfly anchor (P140009)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Demonstration of a consistent surgical approach with successful implantation and functionality of a laryngeal pacemaker, as indicated by the presence of stimulated motion of the chronically paralyzed vocal fold.
Time Frame: 12 to 15 months
12 to 15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Increased glottal area due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.
Time Frame: 12 to 15 months
12 to 15 months
Increased ventilation due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.
Time Frame: 12 to 15 months
12 to 15 months
Minimal impairment of voice due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.
Time Frame: 12 to 15 months
12 to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David L. Zealear, PhD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 141242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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