Laryngeal Pacing Device for Vocal Fold Paralysis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Laryngeal Pacing Device, designed to assist individuals with vocal fold paralysis, which impairs speaking and breathing. The study aims to determine if the device is safe and effective in improving voice and breathing through electrical stimulation of the vocal cords. Participants will have the device activated either early or after a short delay to compare results. Adults who have experienced vocal fold paralysis for at least 10 months and face significant breathing issues may be suitable for the trial. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatment options for vocal fold paralysis.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the laryngeal pacing device is safe for patients with vocal fold paralysis?
Research shows that the laryngeal pacing device may improve voice and breathing for people with paralyzed vocal cords. Earlier studies primarily assessed the device's safety. It sends electrical signals to help move the vocal cords.
Although detailed safety data is limited, researchers closely monitor how patients handle the device due to the focus on safety. Since this trial is beyond its early stages, the device has already passed some initial safety checks.
Studies reviewed have not reported serious side effects in detail, suggesting that patients might tolerate the device well. However, potential participants should discuss any concerns with the trial organizers and their doctor.12345Why are researchers excited about this trial?
Unlike the standard treatments for vocal fold paralysis, which often include voice therapy or surgical interventions like thyroplasty, the laryngeal pacing device offers a novel approach by directly stimulating the muscles controlling the vocal folds. Researchers are excited about this device because it acts as a sort of "pacemaker" for the larynx, potentially restoring voice function by reactivating the paralyzed muscles. This method could provide a more dynamic and natural way of regaining vocal function compared to more static solutions like implants or injections. Additionally, the option for early activation after implantation might lead to quicker improvements in voice quality, offering hope for faster recovery.
What evidence suggests that the laryngeal pacing device is effective for vocal fold paralysis?
Research shows that the laryngeal pacing device can help people with bilateral vocal fold paralysis (BVFP) breathe more easily. Studies have found that this device uses electrical signals to open the vocal cords, aiding in breathing. Earlier studies demonstrated that the device successfully got paralyzed vocal cords moving again. In this trial, participants will be assigned to either early activation or delayed activation of the laryngeal pacing device. People with BVFP have reported better breathing with long-term use of the device. These findings suggest that the device could effectively improve both voice and breathing for those with BVFP.34567
Who Is on the Research Team?
David L. Zealear, PhD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
Adults over 22 with bilateral vocal fold paralysis, who've had repeated botox treatments or nerve reinnervation surgery, may join this trial. They must show a certain level of glottal opening and be willing to follow the study's procedures. Those with autoimmune diseases, heart issues, implanted electronic devices, allergies to device materials or barium dye, significant swallowing difficulties or tracheal narrowing are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo implantation of the laryngeal pacing device followed by activation at one or two months post-implantation
Follow-up
Participants are monitored for safety and effectiveness of the laryngeal pacing device
What Are the Treatments Tested in This Trial?
Interventions
- Laryngeal Pacing Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator