Adductor Spasmodic Dysphonia
Conditions
Interventions
Sponsors
Kumamoto University
Hokkaido University Hospital Yokohama City University Hospital Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of adductor spasmodic dysphonia by a board certified otorhinolaryngologist certified by the Oto-Rhino-Laryngological Society of Japan, Inc. 2. At least 1 year experience of subjective or objective labored speech production, or pauses on certain sounds, due to adductor spasmodic dysphonia 3. A total score of 20 or more on the Voice Handicap Index-10 (VHI-10) 4. Non-responders to voice therapy performed before informed consent 5. 18 through 80 years of age inclusive at the time of informed consent 6. Written informed consent to participate in this study, provided by patients or their legally acceptable representatives
Exclusion criteria
Exclusion criteria: 1. Dysphagia, laryngeal paralysis, or any structural disorder in the vocal cord 2. Previous surgery for adductor spasmodic dysphonia 3. Local injection of botulinum toxin type A into the intralaryngeal muscles within 6 months before informed consent 4. Serious concomitant diseases 5. Surgery with general anesthesia scheduled during the study period or surgery performed within the past 4 weeks 6. Participation in any other study using any other intervention within 12 weeks before informed consent, or planned participation in such a study during the study period after enrollment in this study 7. Psychiatric disorder requiring treatment, or mental or intellectual disability that may affect the conduct of the study 8. A history of alcoholism or drug abuse 9. A history of hypersensitivity to pure titanium 10. Women who are pregnant or planning to become pregnant during the study period 11. Patients deemed ineligible for this study by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in VHI-10 scores at 13 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in VHI-10 scores before and after surgery 2. Changes in VHI scores before and after surgery 3. Changes in VHI subscale scores in the functional (F), (P), and (E) 4. Changes in phonatory function test results before and after surgery 5. Changes in acoustic analysis results 6. Frequency of adverse events and device defects | — |
Countries
Japan
Contacts
Public ContactTetsuji Sanuki
Department of Otolaryngology-Head and Neck Surgery,Kumamoto University Hospital Office for TS-001 Clinical Trial
Outcome results
None listed