Treatment outcomes of selective laryngeal reinnervation for vocal fold paralysis
Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis
Weill Medical College of Cornell University · NCT03980275
This study is testing if a specific surgery can help people with vocal fold paralysis regain their voice and reduce complications after not improving for at least six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03980275 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the outcomes of selective laryngeal reinnervation procedures in patients suffering from bilateral vocal fold paralysis. It aims to assess the effectiveness of this surgical intervention in improving vocal function and reducing complications associated with the condition. The study will include patients aged 18-70 who have not experienced improvement in their condition for at least six months. By closely monitoring these patients, the study seeks to gather valuable data on the long-term benefits and potential risks of the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with bilateral vocal fold paralysis who have not shown improvement for six months.
Not a fit: Patients with severe respiratory compromise or those with certain medical implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve vocal function and quality of life for patients with bilateral vocal fold paralysis.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in improving outcomes for patients with vocal fold paralysis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-70 * Patients with bilateral vocal fold paralysis without any improvement for 6 months Exclusion Criteria: * Patients with neck or chest radiation * Patients with severe respiratory compromise * Patients with cricoarytenoid ankylosis * Patients with pacemakers * Patients who are pregnant * Patients with cochlear implant, or any nerve stimulator implants
Where this trial is running
New York, New York
- Sean Parker Institute for the Voice — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Babak Sadoughi, MD — Weill Medical College of Cornell University
- Study coordinator: Babak Sadoughi, MD
- Email: bas9049@med.cornell.edu
- Phone: 646-962-4712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bilateral Vocal Cord Paralysis, Bilateral vocal fold paralysis, Tracheostomy dependency, Glottic airway obstruction, Stridor