Bilateral Vocal Fold Paralysis (BVFP)BVFP IDENCT03085316
Laryngeal Pacing Study
A study testing Investigational device in people with Bilateral Vocal Fold Paralysis (BVFP), run by Vanderbilt University Medical Center.
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Bilateral Vocal Fold Paralysis (BVFP)
- What is being tested?
- Investigational device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2015to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
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.
Read the 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.
- Conditions
- Bilateral Vocal Fold Paralysis (BVFP)
- Being tested
- Investigational device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational deviceDevice
Also called 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)
Device is an implantable neurostimulation system designed to deliver low-intensity electrical impulses to nerve structures.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Experimental | 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. Receives: Device: Investigational device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 to 15 months
Secondary outcomes (3)
Increased glottal area due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.
Measured: 12 to 15 months
Increased ventilation due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.
Measured: 12 to 15 months
Minimal impairment of voice due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.
Measured: 12 to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start26 Oct 2015
- Primary completion19 Jul 2023
- Study completion7 Nov 2023
Why it stopped: The study was halted early as grant funding was awarded for a new study, which was opened in place of this one.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Vocal Fold Paralysis (BVFP)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients who meet eligibility will undergo device implantation surgery and follow up per protocol.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, David Zealear, PhD, Vanderbilt University Medical Center
- Investigators
- David L. Zealear, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085316
- Sponsor's protocol ID
- 141242
- Acronym
- BVFP IDE
- Status last verified
- Jan 2025
- First submitted
- 14 Mar 2017
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation of Laryngeal Muscles to Restore Glottal Opening in Patients with Bilateral Vocal Fold Paralysis
- ClinicalTrials.gov ID
- NCT03085316
- Acronym / sponsor ID
- BVFP IDE / 141242
- Conditions
- Bilateral Vocal Fold Paralysis (BVFP)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted early as grant funding was awarded for a new study, which was opened in place of this one.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 26 Oct 2015 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients who meet eligibility will undergo device implantation surgery and follow up per protocol.
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: Investigational devicePatient 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational deviceAlso: 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)Device is an implantable neurostimulation system designed to deliver low-intensity electrical impulses to nerve structures. | Device | Investigational Device |
Primary outcome
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
3 secondary outcomes
Increased glottal area due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.
Time frame: 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
Minimal impairment of voice due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.
Time frame: 12 to 15 months
Results and safety
The study was stopped early (reason given: The study was halted early as grant funding was awarded for a new study, which was opened in place of this one.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Bilateral Vocal Fold Paralysis (BVFP)
Active, not recruiting
Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx
Bilateral Vocal Fold Paralysis (BVFP)
Active, not recruiting
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
Bilateral Vocal Cord Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L. Zealear, PhD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device in people with Bilateral Vocal Fold Paralysis (BVFP), run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was halted early as grant funding was awarded for a new study, which was opened in place of this one.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.