Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT02528006
Eligibility 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:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02528006
Study Brief:
Protocol Section:
NCT02528006