Topic: Ear, Nose and Throat
Conditions
Interventions
Interventions as of 08/09/2016:
Participants are randomly allocated to one of two groups.
Group 1: Participants receive laryngeal reinnervation treatment with temporary medialisation (via an injectio
Sponsors
University College London Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Age from 18 to 70 years old. 3. Male or female 4. Able to provide informed consent 5. A significant voice disorder as measured by perceptual rating (Grade =2 GRBAS Scale) and Voice Handicap Index (VHI-10 score >16) 6. Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades 2-5) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the paralysed side Original inclusion criteria 1-2: 1. UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 36 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 2. Aged between 18 and 60
Exclusion criteria
Exclusion criteria: 1. Impaired vocal fold mobility but a normal EMG (Koufman Grade I) 2. Severe lung disorders 3. Structural vocal fold lesions such as polyp 4. Previous laryngeal framework surgery 5. Cricoarytenoid joint fixation (CAJF) 6. Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists) 7. Previous Level 2,3 or 4 thyroid neck dissection 8. Previous ipsilateral surgical neck dissection 9. Previous radiotherapy to the head and neck 10. Laryngeal injection of a rapidly absorbable material in the last 6 months 11. Previous laryngeal injection of a non-rapidly absorbable material (e.g bioplastics, VOX) 12. Neuromuscular disease affecting the larynx or multiple cranial nerve palsies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
England, United Kingdom
Outcome results
None listed