Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty Using Titanium Bridges (NCT02528006) | Clinical Trial Compass
CompletedPhase 2/3
Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty Using Titanium Bridges
Japan20 participantsStarted 2015-07-27
Plain-language summary
For adductor spasmodic dysphonia, there is a need for establishing a new therapy under the present circumstance where no standard therapy has been established yet and existing therapies fail to provide permanent effect. Evaluation of the efficacy of type 2 thyroplasty using titanium bridges will expand the therapeutic options available for adductor spasmodic dysphonia and establishment of a standard therapy.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of adductor spasmodic dysphonia by a board certified otorhinolaryngologist certified by the Oto-Rhino-Laryngological Society of Japan, Inc.
✓. At least 1 year experience of subjective or objective labored speech production, or pauses on certain sounds, due to adductor spasmodic dysphonia
✓. A total score of 20 or more on the Voice Handicap Index-10 (VHI-10)
✓. Non-responders to voice therapy performed before informed consent
✓. 18 through 80 years of age inclusive at the time of informed consent
✓. Written informed consent to participate in this study, provided by patients or their legally acceptable representatives
Exclusion criteria
✕. Dysphagia, laryngeal paralysis, or any structural disorder in the vocal cord
✕. Previous surgery for adductor spasmodic dysphonia
✕. Local injection of botulinum toxin type A into the intralaryngeal muscles within 6 months before informed consent
✕. Serious concomitant diseases
✕. Surgery with general anesthesia scheduled during the study period or surgery performed within the past 4 weeks
✕. 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
What they're measuring
1
Change in VHI-10 scores assessed by Change from baseline in VHI-10 scores at 13 weeks after surgery