Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness. (NCT02973152) | Clinical Trial Compass
CompletedPhase 2
Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.
United Kingdom23 participantsStarted 2016-05
Plain-language summary
The purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis.
There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Doctors place a small piece of safe plastic into the side of the participant's voice box to push the weak vocal cord into a position to enable better speech and swallowing. In the other operation called laryngeal reinnervation, doctors repair the neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better speech and swallowing. The investigators do not know which of these methods is better and are conducting this study to start comparing the two operations so that a larger clinical trial can be conducted in the future to tell us which operation is best.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 60 months duration. Or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision.
* Age from 18 to 70 years old
* Male or female
* Able to provide informed consent
* A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-10 score \>16)
* Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades 2-5) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the paralysed side.
Exclusion Criteria:
* Impaired vocal fold mobility but a normal EMG (Koufman Grade I)
* Severe lung disorders
* Structural vocal fold lesions such as polyp
* Previous laryngeal framework surgery
* Cricoarytenoid joint fixation (CAJF)
* Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
* Previous Level 2, 3 or 4 thyroid neck dissection
* Previous ipsilateral surgical neck dissection
* Previous radiotherapy to the head and neck
* Laryngeal injection of a rapidly absorbable material in the last 6 months.
* Previous laryngeal injection of a non-rapidly absorbable material (e.g. bioplastics, VOX)
* Neuromuscular disease affecting the larynx or multiple crania…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Whether the participant was randomised (yes/no)
Timeframe: 24 months
2
Whether the participant successfully received the allocated operation (yes/no)
Timeframe: 24 months
3
Whether the participant completed the trial (yes/no)
Timeframe: 24 months
Trial details
NCT IDNCT02973152
SponsorRoyal National Throat, Nose and Ear Hospital