Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty using Titanium Bridges
- Conditions
- Adductor Spasmodic Dysphonia
- Registration Number
- JPRN-UMIN000018626
- Lead Sponsor
- Kumamoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in VHI-10 scores at 13 weeks after surgery
- Secondary Outcome Measures
Name Time Method 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