Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for patients with Unilateral Vocal Fold Paralysis (VOCALIST): a feasibility study

niversity College London Hospitals NHS Foundation Trust0 个研究点目标入组 30 人开始时间: 2015年12月16日最近更新: 2021年1月5日

适应症

试验速览

•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

•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

发起方

niversity College London Hospitals NHS Foundation Trust